Press Release: Sanofi and Regeneron’s Dupixent approved in Japan for children aged 6 to 11 years with bronchial asthma

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Press Release: Sanofi and Regeneron’s Dupixent approved in Japan for children aged 6 to 11 years with bronchial asthma

Press Release: Sanofi and Regeneron’s Dupixent approved in Japan for children aged 6 to 11 years with bronchial asthma

Sanofi and Regeneron’s Dupixent approved in Japan for children aged 6 to 11 years with bronchial asthma

Approval based on global phase 3 program in children demonstrating Dupixent significantly reduced exacerbations (by 54% to 65%) and improved lung function compared to placebo (by 4.68% to 5.32%)
Dupixent is the first and only biologic medicine to demonstrate improved lung function in this young patient group in a randomized phase 3 study, and inhibits IL-4 and IL-13, two key and central drivers of type 2 inflammation

Paris and Tarrytown, NY, December 23, 2025. The Ministry of Health, Labour and Welfare in Japan has granted marketing and manufacturing authorization for Dupixent (dupilumab) for the treatment of bronchial asthma in children aged 6 to 11 years with severe or refractory disease whose symptoms are inadequately controlled with existing therapy. This expands the previous approval in Japan in this indication for patients aged 12 years and older.

The approval in Japan is based on data from the overall population and those with a type 2 inflammation phenotype (defined by raised blood eosinophils and/or fractional exhaled nitric oxide) in VOYAGE (NCT02948959), a global phase 3 study evaluating Dupixent in children aged 6 to 11 years with uncontrolled moderate-to-severe asthma. Additionally, data from EXCURSION (NCT03560466), an open-label extension of VOYAGE that included a sub-study of exclusively Japanese pediatric patients supported the approval. In the VOYAGE study, Dupixent added to standard-of-care asthma therapy significantly reduced severe exacerbations (by 54% to 65%, p<0.0001) and improved lung function (by 4.68% to 5.32%, p=0.0012, p=0.0009 and p=0.0036, respectively) in the overall population, those with type 2 inflammation , and those with raised blood eosinophils, compared to placebo. In the sub-study of Japanese pediatric patients, Dupixent improved lung function from baseline at 12 weeks and resulted in a low rate of severe asthma exacerbations over one year. The treatment-related adverse events most commonly reported with Dupixent were injection site reactions (erythema, edema, and induration) in VOYAGE and fever, oral herpes, eosinophilia, and injection site reactions (erythema and induration) in EXCURSION.

Asthma is one of the most common chronic diseases in children. Despite treatment with current standard-of-care inhaled corticosteroids and bronchodilators, children may continue to experience serious symptoms such as coughing, wheezing, and difficulty breathing. Additionally, impaired lung function in young children can have potentially long-lasting impacts such as reduced lung growth and persistent airway obstruction, if not addressed early. Patients also may require the use of multiple courses of systemic corticosteroids that carry significant risks. Uncontrolled asthma can interfere with day-to-day activities, like sleeping, attending school, and playing sports.

In addition to asthma, Dupixent is approved in Japan in certain patients with atopic dermatitis, chronic rhinosinusitis with nasal polyposis (CRSwNP), prurigo nodularis, chronic spontaneous urticaria (CSU), and chronic obstructive pulmonary disease (COPD). Dupixent has been approved in 50 countries around the world for the treatment of asthma in children aged 6 to 11 years.
About Dupixent
Dupixent (dupilumab) is available in Japan as a 200 mg or 300 mg pre-filled syringe or pre-filled pen and is now available for children aged 6 to 11 years with asthma. Dupixent is intended for injection under the skin (subcutaneous injection) and is given every two or four weeks based on weight. It can be given in a clinic or at home by self-administration after training by a healthcare professional. In children younger than 12 years of age, Dupixent should be administered by a caregiver if given at home.

Dupixent is a fully human monoclonal antibody that inhibits the signaling of the interleukin-4 (IL4) and interleukin-13 (IL13) pathways and is not an immunosuppressant. The Dupixent development program has shown significant clinical benefit and a decrease in type 2 inflammation in phase 3 studies, establishing that IL4 and IL13 are two of the key and central drivers of the type 2 inflammation that plays a major role in multiple related and often co-morbid diseases.

Dupixent has received regulatory approvals in more than 60 countries in one or more indications including certain patients with atopic dermatitis, asthma, CRSwNP, eosinophilic esophagitis, prurigo nodularis, CSU, COPD, and BP in different age populations. More than 1.3 million patients are being treated with Dupixent globally.

Dupilumab development program
Dupilumab is being jointly developed by Sanofi and Regeneron under a global collaboration agreement. To date, dupilumab has been studied across more than 60 clinical studies involving more than 10,000 patients with various chronic diseases driven in part by type 2 inflammation.

In addition to the currently approved indications, Sanofi and Regeneron are studying dupilumab in a broad range of diseases driven by type 2 inflammation or other allergic processes in phase 3 studies, including chronic pruritus of unknown origin, lichen simplex chronicus, and allergic fungal rhinosinusitis. These potential uses of dupilumab are currently under clinical investigation, and the safety and efficacy in these conditions have not been fully evaluated by any regulatory authority.

About Regeneron
Regeneron (NASDAQ: REGN) is a leading biotechnology company that invents, develops and commercializes life-transforming medicines for people with serious diseases. Founded and led by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to numerous approved treatments and product candidates in development, most of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, neurological diseases, hematologic conditions, infectious diseases, and rare diseases.

Regeneron pushes the boundaries of scientific discovery and accelerates drug development using our proprietary technologies, such as VelociSuite^®, which produces optimized fully human antibodies and new classes of bispecific antibodies. We are shaping the next frontier of medicine with data-powered insights from the Regeneron Genetics Center^® and pioneering genetic medicine platforms, enabling us to identify innovative targets and complementary approaches to potentially treat or cure diseases.

For more information, please visit www.Regeneron.com or follow Regeneron on LinkedIn, Instagram, Facebook or X.

About Sanofi
Sanofi is an R&D driven, AI-powered biopharma company committed to improving people’s lives and delivering compelling growth. We apply our deep understanding of the immune system to invent medicines and vaccines that treat and protect millions of people around the world, with an innovative pipeline that could benefit millions more. Our team is guided by one purpose: we chase the miracles of science to improve people’s lives; this inspires us to drive progress and deliver positive impact for our people and the communities we serve, by addressing the most urgent healthcare, environmental, and societal challenges of our time.

Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY.

Sanofi Media Relations
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Regeneron Media Relations
Sharon Chen | +1 914-847-1546| sharon.chen@regeneron.com

Regeneron Investor Relations
Mark Hudson | +1 914-847-3482 | mark.hudson@regeneron.com

Sanofi forward-looking statements
This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include projections and estimates regarding the marketing and other potential of the product, or regarding potential future revenues from the product. Forward-looking statements are generally identified by the words “expects”, “anticipates”, “believes”, “intends”, “estimates”, “plans”, and similar expressions. Although Sanofi’s management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Sanofi, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, unexpected regulatory actions or delays, or government regulation generally, that could affect the availability or commercial potential of the product, the fact that product may not be commercially successful, the uncertainties inherent in research and development, including future clinical data and analysis of existing clinical data relating to the product, including post marketing, unexpected safety, quality or manufacturing issues, competition in general, risks associated with intellectual property and any related future litigation and the ultimate outcome of such litigation, and volatile economic and market conditions, and the impact that global crises may have on us, our customers, suppliers, vendors, and other business partners, and the financial condition of any one of them, as well as on our employees and on the global economy as a whole. The risks and uncertainties also include the uncertainties discussed or identified in the public filings with the SEC and the AMF made by Sanofi, including those listed under “Risk Factors” and “Cautionary Statement Regarding Forward-Looking Statements” in Sanofi’s annual report on Form 20-F for the year ended December 31, 2024. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements.

All trademarks mentioned in this press release are the property of the Sanofi group except for VelociSuite and Regeneron Genetics Center.

Regeneron Forward-Looking Statements and Use of Digital Media
This press release includes forward-looking statements that involve risks and uncertainties relating to future events and the future performance of Regeneron Pharmaceuticals, Inc. (“Regeneron” or the “Company”), and actual events or results may differ materially from these forward-looking statements. Words such as “anticipate,” “expect,” “intend,” “plan,” “believe,” “seek,” “estimate,” variations of such words, and similar expressions are intended to identify such forward-looking statements, although not all forward-looking statements contain these identifying words. These statements concern, and these risks and uncertainties include, among others, the nature, timing, and possible success and therapeutic applications of products marketed or otherwise commercialized by Regeneron and/or its collaborators or licensees (collectively, “Regeneron’s Products”) and product candidates being developed by Regeneron and/or its collaborators or licensees (collectively, “Regeneron’s Product Candidates”) and research and clinical programs now underway or planned, including without limitation Dupixent^® (dupilumab) for the treatment of bronchial asthma in children aged 6 to 11 years pursuant to the approval by Japan’s Ministry of Health, Labour and Welfare (MHLW) discussed in this press release; the likelihood, timing, and scope of possible regulatory approval and commercial launch of Regeneron’s Product Candidates and new indications for Regeneron’s Products, including Dupixent for the treatment of chronic pruritus of unknown origin, lichen simplex chronicus, allergic fungal rhinosinusitis, and other potential indications; uncertainty of the utilization, market acceptance, and commercial success of Regeneron’s Products (such as Dupixent) and Regeneron’s Product Candidates and the impact of studies (whether conducted by Regeneron or others and whether mandated or voluntary), including the studies discussed or referenced in this press release, on any of the foregoing; the ability of Regeneron’s collaborators, licensees, suppliers, or other third parties (as applicable) to perform manufacturing, filling, finishing, packaging, labeling, distribution, and other steps related to Regeneron’s Products and Regeneron’s Product Candidates; the ability of Regeneron to manage supply chains for multiple products and product candidates and risks associated with tariffs and other trade restrictions; safety issues resulting from the administration of Regeneron’s Products (such as Dupixent) and Regeneron’s Product Candidates in patients, including serious complications or side effects in connection with the use of Regeneron’s Products and Regeneron’s Product Candidates in clinical trials; determinations by regulatory and administrative governmental authorities which may delay or restrict Regeneron’s ability to continue to develop or commercialize Regeneron’s Products and Regeneron’s Product Candidates; ongoing regulatory obligations and oversight impacting Regeneron’s Products, research and clinical programs, and business, including those relating to patient privacy; the availability and extent of reimbursement or copay assistance for Regeneron’s Products from third-party payors and other third parties, including private payor healthcare and insurance programs, health maintenance organizations, pharmacy benefit management companies, and government programs such as Medicare and Medicaid; coverage and reimbursement determinations by such payors and other third parties and new policies and procedures adopted by such payors and other third parties; changes to drug pricing regulations and requirements and Regeneron’s pricing strategy; other changes in laws, regulations, and policies affecting the healthcare industry; competing drugs and product candidates that may be superior to, or more cost effective than, Regeneron’s Products and Regeneron’s Product Candidates (including biosimilar versions of Regeneron’s Products); the extent to which the results from the research and development programs conducted by Regeneron and/or its collaborators or licensees may be replicated in other studies and/or lead to advancement of product candidates to clinical trials, therapeutic applications, or regulatory approval; unanticipated expenses; the costs of developing, producing, and selling products; the ability of Regeneron to meet any of its financial projections or guidance and changes to the assumptions underlying those projections or guidance; the potential for any license, collaboration, or supply agreement, including Regeneron’s agreements with Sanofi and Bayer (or their respective affiliated companies, as applicable), to be cancelled or terminated; the impact of public health outbreaks, epidemics, or pandemics on Regeneron’s business; and risks associated with litigation and other proceedings and government investigations relating to the Company and/or its operations (including the pending civil proceedings initiated or joined by the U.S. Department of Justice and the U.S. Attorney’s Office for the District of Massachusetts), risks associated with intellectual property of other parties and pending or future litigation relating thereto (including without limitation the patent litigation and other related proceedings relating to EYLEA® (aflibercept) Injection), the ultimate outcome of any such proceedings and investigations, and the impact any of the foregoing may have on Regeneron’s business, prospects, operating results, and financial condition. A more complete description of these and other material risks can be found in Regeneron’s filings with the U.S. Securities and Exchange Commission, including its Form 10-K for the year ended December 31, 2024 and its Form 10-Q for the quarterly period ended September 30, 2025. Any forward-looking statements are made based on management’s current beliefs and judgment, and the reader is cautioned not to rely on any forward-looking statements made by Regeneron. Regeneron does not undertake any obligation to update (publicly or otherwise) any forward-looking statement, including without limitation any financial projection or guidance, whether as a result of new information, future events, or otherwise.

Regeneron uses its media and investor relations website and social media outlets to publish important information about the Company, including information that may be deemed material to investors. Financial and other information about Regeneron is routinely posted and is accessible on Regeneron’s media and investor relations website (https://investor.regeneron.com) and its LinkedIn page (https://www.linkedin.com/company/regeneron-pharmaceuticals).

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Press_Release

Press Release: Sanofi and Regeneron’s Dupixent approved in Japan for children aged 6 to 11 years with bronchial asthma

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Sanofi and Regeneron’s Dupixent approved in Japan for children aged 6 to 11 years with bronchial asthma

Approval based on global phase 3 program in children demonstrating Dupixent significantly reduced exacerbations (by 54% to 65%) and improved lung function compared to placebo (by 4.68% to 5.32%)
Dupixent is the first and only biologic medicine to demonstrate improved lung function in this young patient group in a randomized phase 3 study, and inhibits IL-4 and IL-13, two key and central drivers of type 2 inflammation

For more information, please visit www.Regeneron.com or follow Regeneron on LinkedIn, Instagram, Facebook or X.

Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY.

Regeneron Media Relations
Sharon Chen | +1 914-847-1546| sharon.chen@regeneron.com

Regeneron Investor Relations
Mark Hudson | +1 914-847-3482 | mark.hudson@regeneron.com

All trademarks mentioned in this press release are the property of the Sanofi group except for VelociSuite and Regeneron Genetics Center.

Attachment

Press_Release

Dupixent® (dupilumab) Approved in Japan for Children Aged 6 to 11 Years with Bronchial Asthma

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Dupixent® (dupilumab) Approved in Japan for Children Aged 6 to 11 Years with Bronchial Asthma

Dupixent® (dupilumab) Approved in Japan for Children Aged 6 to 11 Years with Bronchial Asthma

Approval based on global Phase 3 program in children demonstrating Dupixent significantly reduced exacerbations (by 54% to 65%) and improved lung function (by 4.68% to 5.32%) compared to placebo

Dupixent is the first and only biologic medicine to demonstrate improved lung function in this young patient group in a randomized Phase 3 trial, and inhibits IL-4 and IL-13, two key and central drivers of type 2 inflammation

TARRYTOWN, N.Y. and PARIS, Dec. 23, 2025 (GLOBE NEWSWIRE) — Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced that the Ministry of Health, Labour and Welfare (MHLW) in Japan has granted marketing and manufacturing authorization for Dupixent^® (dupilumab) for the treatment of bronchial asthma in children aged 6 to 11 years with severe or refractory disease whose symptoms are inadequately controlled with existing therapy. This expands the previous approval in Japan in this indication for patients aged 12 years and older.

The approval in Japan is based on data from the overall population and those with a type 2 inflammation phenotype (defined by raised blood eosinophils and/or fractional exhaled nitric oxide) in VOYAGE, a global Phase 3 trial evaluating Dupixent in children aged 6 to 11 years with uncontrolled moderate-to-severe asthma. Additionally, data from EXCURSION, an open-label extension of VOYAGE that included a sub-study of exclusively Japanese pediatric patients supported the approval. In the VOYAGE trial, Dupixent added to standard-of-care asthma therapy significantly reduced severe exacerbations (by 54% to 65%, p<0.0001) and improved lung function (by 4.68% to 5.32%, p=0.0012, p=0.0009 and p=0.0036, respectively) in the overall population, those with type 2 inflammation, and those with raised blood eosinophils, compared to placebo. In the sub-study of Japanese pediatric patients, Dupixent improved lung function from baseline at 12 weeks and resulted in a low rate of severe asthma exacerbations over one year. The treatment-related adverse events most commonly reported with Dupixent were injection site reactions (erythema, edema and induration) in VOYAGE and fever, oral herpes, eosinophilia and injection site reactions (erythema and induration) in EXCURSION.

Asthma is one of the most common chronic diseases in children. Despite treatment with current standard-of-care inhaled corticosteroids and bronchodilators, children may continue to experience serious symptoms, such as coughing, wheezing and difficulty breathing. Additionally, impaired lung function in young children can have potentially long-lasting impacts, such as reduced lung growth and persistent airway obstruction, if not addressed early. Patients also may require the use of multiple courses of systemic corticosteroids that carry significant risks. Uncontrolled asthma can interfere with day-to-day activities, like sleeping, attending school and playing sports.

About Dupixent
Dupixent is available in Japan as a 200 mg or 300 mg pre-filled syringe or pre-filled pen and is now available for children aged 6 to 11 years with asthma. Dupixent is intended for injection under the skin (subcutaneous injection) and is given every two or four weeks based on weight. It can be given in a clinic or at home by self-administration after training by a healthcare professional. In children younger than 12 years of age, Dupixent should be administered by a caregiver if given at home.

Dupixent, which was invented using Regeneron’s proprietary VelocImmune^® technology, is a fully human monoclonal antibody that inhibits the signaling of the interleukin-4 (IL-4) and interleukin-13 (IL-13) pathways and is not an immunosuppressant. The Dupixent development program has shown significant clinical benefit and a decrease in type 2 inflammation in Phase 3 trials, establishing that IL-4 and IL-13 are two of the key and central drivers of the type 2 inflammation that plays a major role in multiple related and often co-morbid diseases.

Dupixent has received regulatory approvals in more than 60 countries in one or more indications including certain patients with atopic dermatitis, asthma, CRSwNP, eosinophilic esophagitis (EoE), prurigo nodularis, CSU, COPD and bullous pemphigoid (BP) in different age populations. More than 1,300,000 patients are being treated with Dupixent globally.¹

About Regeneron’s VelocImmune Technology
Regeneron’s VelocImmune technology utilizes a proprietary genetically engineered mouse platform endowed with a genetically humanized immune system to produce optimized fully human antibodies. When Regeneron’s co-Founder, President and Chief Scientific Officer George D. Yancopoulos was a graduate student with his mentor Frederick W. Alt in 1985, they were the first to envision making such a genetically humanized mouse, and Regeneron has spent decades inventing and developing VelocImmune and related VelociSuite^® technologies. Dr. Yancopoulos and his team have used VelocImmune technology to create a substantial proportion of all original, FDA-approved fully human monoclonal antibodies. This includes Dupixent^® (dupilumab), Libtayo^®(cemiplimab-rwlc), Praluent^® (alirocumab), Kevzara^® (sarilumab), Evkeeza^® (evinacumab-dgnb), Inmazeb^® (atoltivimab, maftivimab and odesivimab-ebgn) and Veopoz^® (pozelimab-bbfg). In addition, REGEN-COV^® (casirivimab and imdevimab) had been authorized by the FDA during the COVID-19 pandemic until 2024.

Dupilumab Development Program
Dupilumab is being jointly developed by Regeneron and Sanofi under a global collaboration agreement. To date, dupilumab has been studied across more than 60 clinical trials involving more than 10,000 patients with various chronic diseases driven in part by type 2 inflammation.

In addition to the currently approved indications, Regeneron and Sanofi are studying dupilumab in a broad range of diseases driven by type 2 inflammation or other allergic processes in Phase 3 trials, including chronic pruritus of unknown origin, lichen simplex chronicus and allergic fungal rhinosinusitis. These potential uses of dupilumab are currently under clinical investigation, and the safety and efficacy in these conditions have not been fully evaluated by any regulatory authority.

U.S. INDICATIONS
DUPIXENT is a prescription medicine used:

to treat adults and children 6 months of age and older with moderate-to-severe eczema (atopic dermatitis or AD) that is not well controlled with prescription therapies used on the skin (topical), or who cannot use topical therapies. DUPIXENT can be used with or without topical corticosteroids. It is not known if DUPIXENT is safe and effective in children with AD under 6 months of age.
with other asthma medicines for the maintenance treatment of moderate-to-severe eosinophilic or oral steroid dependent asthma in adults and children 6 years of age and older whose asthma is not controlled with their current asthma medicines. DUPIXENT helps prevent severe asthma attacks (exacerbations) and can improve your breathing. DUPIXENT may also help reduce the amount of oral corticosteroids you need while preventing severe asthma attacks and improving your breathing. It is not known if DUPIXENT is safe and effective in children with asthma under 6 years of age.
with other medicines for the maintenance treatment of chronic rhinosinusitis with nasal polyps (CRSwNP) in adults and children 12 years of age and older whose disease is not controlled. It is not known if DUPIXENT is safe and effective in children with CRSwNP under 12 years of age.
to treat adults and children 1 year of age and older with eosinophilic esophagitis (EoE), who weigh at least 33 pounds (15 kg). It is not known if DUPIXENT is safe and effective in children with EoE under 1 year of age, or who weigh less than 33 pounds (15 kg).
to treat adults with prurigo nodularis (PN). It is not known if DUPIXENT is safe and effective in children with PN under 18 years of age.
with other medicines for the maintenance treatment of adults with inadequately controlled chronic obstructive pulmonary disease (COPD) and a high number of blood eosinophils (a type of white blood cell that may contribute to your COPD). DUPIXENT is used to reduce the number of flare-ups (the worsening of your COPD symptoms for several days) and can improve your breathing. It is not known if DUPIXENT is safe and effective in children with COPD under 18 years of age.
to treat adults and children 12 years of age and older with chronic spontaneous urticaria (CSU) who continue to have hives that are not controlled with H1 antihistamine treatment. It is not known if DUPIXENT is safe and effective in children with CSU under 12 years of age, or who weigh less than 66 pounds (30 kg).
to treat adults with bullous pemphigoid (BP). It is not known if DUPIXENT is safe and effective in children with BP under 18 years of age.

DUPIXENT is not used to relieve sudden breathing problems and will not replace an inhaled rescue medicine or to treat any other forms of hives (urticaria).

IMPORTANT SAFETY INFORMATION

Do not use if you are allergic to dupilumab or to any of the ingredients in DUPIXENT^®.

Before using DUPIXENT, tell your healthcare provider about all your medical conditions, including if you:

have eye problems.
have a parasitic (helminth) infection.
are scheduled to receive any vaccinations. You should not receive a “live vaccine” right before and during treatment with DUPIXENT.
are pregnant or plan to become pregnant. It is not known whether DUPIXENT will harm your unborn baby.
- A pregnancy registry for women who take DUPIXENT during pregnancy collects information about the health of you and your baby. To enroll or get more information call 1-877-311-8972 or go to https://mothertobaby.org/ongoing-study/dupixent/.
are breastfeeding or plan to breastfeed. It is not known whether DUPIXENT passes into your breast milk.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Especially tell your healthcare provider if you are taking oral, topical, or inhaled corticosteroid medicines; have asthma and use an asthma medicine; or have AD, CRSwNP, EoE, PN, COPD, CSU, or BP and also have asthma. Do not change or stop your other medicines, including corticosteroid medicine or other asthma medicine, without talking to your healthcare provider. This may cause other symptoms that were controlled by those medicines to come back.

DUPIXENT can cause serious side effects, including:

Allergic reactions. DUPIXENT can cause allergic reactions, including skin reactions, that can sometimes be severe. Stop using DUPIXENT and tell your healthcare provider or get emergency help right away if you get any of the following signs or symptoms: breathing problems or wheezing, swelling of the face, lips, mouth, tongue or throat, fainting, dizziness, feeling lightheaded, fast pulse, fever, hives, skin rash, including rash that looks like a bullseye, painful red or blue bumps under the skin, or red pus-filled spots on the skin, general ill feeling, itching, swollen lymph nodes, nausea or vomiting, joint pain, or cramps in your stomach area.
Eye problems. Tell your healthcare provider if you have any new or worsening eye problems, including eye pain or changes in vision, such as blurred vision. Your healthcare provider may send you to an ophthalmologist for an exam if needed.
Inflammation of your blood vessels. Rarely, this can happen in people with asthma who receive DUPIXENT. This may happen in people who also take a steroid medicine by mouth that is being stopped or the dose is being lowered. Tell your healthcare provider right away if you get: rash, chest pain, worsening shortness of breath, brown or dark colored urine, persistent fever, or a feeling of pins and needles or numbness of your arms or legs.
Psoriasis. This can happen in people with atopic dermatitis and asthma who receive DUPIXENT. Tell your healthcare provider about any new skin symptoms. Your healthcare provider may send you to a dermatologist for an examination if needed.
Joint aches and pain. Some people who use DUPIXENT have had trouble walking or moving due to their joint symptoms, and in some cases needed to be hospitalized. Tell your healthcare provider about any new or worsening joint symptoms. Your healthcare provider may stop DUPIXENT if you develop joint symptoms.

The most common side effects include:

Eczema: injection site reactions, eye problems, including eye and eyelid inflammation, redness, swelling, itching, eye infection, dry eye, and blurred vision, cold sores in your mouth or on your lips, and high count of a certain white blood cell (eosinophilia).
Asthma: injection site reactions, high count of a certain white blood cell (eosinophilia), pain in the throat (oropharyngeal pain), and parasitic (helminth) infections.
Chronic Rhinosinusitis with Nasal Polyps: injection site reactions, eye problems, including eye and eyelid inflammation, redness, swelling, itching, eye infection, and blurred vision, high count of a certain white blood cell (eosinophilia), stomach problems (gastritis), joint pain (arthralgia), trouble sleeping (insomnia), and toothache.
Eosinophilic Esophagitis: injection site reactions, upper respiratory tract infections, cold sores in your mouth or on your lips, and joint pain (arthralgia).
Prurigo Nodularis: eye problems, including eye and eyelid inflammation, redness, swelling, itching, and blurred vision, herpes virus infections, common cold symptoms (nasopharyngitis), dizziness, muscle pain, and diarrhea.
Chronic Obstructive Pulmonary Disease: injection site reactions, common cold symptoms (nasopharyngitis), high count of a certain white blood cell (eosinophilia), viral infection, back pain, inflammation inside the nose (rhinitis), diarrhea, stomach problems (gastritis), joint pain (arthralgia), toothache, headache, and urinary tract infection.
Chronic Spontaneous Urticaria: injection site reactions.
Bullous Pemphigoid: joint pain (arthralgia), eye problems, including eye and eyelid inflammation, redness, swelling, itching, and blurred vision, and herpes virus infections.

Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of DUPIXENT. Call your doctor for medical advice about side effects. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

Use DUPIXENT exactly as prescribed by your healthcare provider. It’s an injection given under the skin (subcutaneous injection). Your healthcare provider will decide if you or your caregiver can inject DUPIXENT. Do not try to prepare and inject DUPIXENT until you or your caregiver have been trained by your healthcare provider. In children 12 years of age and older, it’s recommended DUPIXENT be administered by or under supervision of an adult. In children 6 months to less than 12 years of age, DUPIXENT should be given by a caregiver.

Please see accompanying full Prescribing Information including Patient Information.

Regeneron pushes the boundaries of scientific discovery and accelerates drug development using our proprietary technologies, such as VelociSuite, which produces optimized fully human antibodies and new classes of bispecific antibodies. We are shaping the next frontier of medicine with data-powered insights from the Regeneron Genetics Center^® and pioneering genetic medicine platforms, enabling us to identify innovative targets and complementary approaches to potentially treat or cure diseases.

For more information, please visit www.Regeneron.com or follow Regeneron on LinkedIn, Instagram, Facebook or X.

About Sanofi
Sanofi is an R&D driven, AI-powered biopharma company committed to improving people’s lives and delivering compelling growth. We apply our deep understanding of the immune system to invent medicines and vaccines that treat and protect millions of people around the world, with an innovative pipeline that could benefit millions more. Our team is guided by one purpose: we chase the miracles of science to improve people’s lives; this inspires us to drive progress and deliver positive impact for our people and the communities we serve, by addressing the most urgent healthcare, environmental, and societal challenges of our time.

Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY

Regeneron Forward-Looking Statements and Use of Digital Media
This press release includes forward-looking statements that involve risks and uncertainties relating to future events and the future performance of Regeneron Pharmaceuticals, Inc. (“Regeneron” or the “Company”), and actual events or results may differ materially from these forward-looking statements. Words such as “anticipate,” “expect,” “intend,” “plan,” “believe,” “seek,” “estimate,” variations of such words, and similar expressions are intended to identify such forward-looking statements, although not all forward-looking statements contain these identifying words. These statements concern, and these risks and uncertainties include, among others, the nature, timing, and possible success and therapeutic applications of products marketed or otherwise commercialized by Regeneron and/or its collaborators or licensees (collectively, “Regeneron’s Products”) and product candidates being developed by Regeneron and/or its collaborators or licensees (collectively, “Regeneron’s Product Candidates”) and research and clinical programs now underway or planned, including without limitation Dupixent® (dupilumab) for the treatment of bronchial asthma in children aged 6 to 11 years pursuant to the approval by Japan’s Ministry of Health, Labour and Welfare (MHLW) discussed in this press release; the likelihood, timing, and scope of possible regulatory approval and commercial launch of Regeneron’s Product Candidates and new indications for Regeneron’s Products, including Dupixent for the treatment of chronic pruritus of unknown origin, lichen simplex chronicus, allergic fungal rhinosinusitis, and other potential indications; uncertainty of the utilization, market acceptance, and commercial success of Regeneron’s Products (such as Dupixent) and Regeneron’s Product Candidates and the impact of studies (whether conducted by Regeneron or others and whether mandated or voluntary), including the studies discussed or referenced in this press release, on any of the foregoing; the ability of Regeneron’s collaborators, licensees, suppliers, or other third parties (as applicable) to perform manufacturing, filling, finishing, packaging, labeling, distribution, and other steps related to Regeneron’s Products and Regeneron’s Product Candidates; the ability of Regeneron to manage supply chains for multiple products and product candidates and risks associated with tariffs and other trade restrictions; safety issues resulting from the administration of Regeneron’s Products (such as Dupixent) and Regeneron’s Product Candidates in patients, including serious complications or side effects in connection with the use of Regeneron’s Products and Regeneron’s Product Candidates in clinical trials; determinations by regulatory and administrative governmental authorities which may delay or restrict Regeneron’s ability to continue to develop or commercialize Regeneron’s Products and Regeneron’s Product Candidates; ongoing regulatory obligations and oversight impacting Regeneron’s Products, research and clinical programs, and business, including those relating to patient privacy; the availability and extent of reimbursement or copay assistance for Regeneron’s Products from third-party payors and other third parties, including private payor healthcare and insurance programs, health maintenance organizations, pharmacy benefit management companies, and government programs such as Medicare and Medicaid; coverage and reimbursement determinations by such payors and other third parties and new policies and procedures adopted by such payors and other third parties; changes to drug pricing regulations and requirements and Regeneron’s pricing strategy; other changes in laws, regulations, and policies affecting the healthcare industry; competing drugs and product candidates that may be superior to, or more cost effective than, Regeneron’s Products and Regeneron’s Product Candidates (including biosimilar versions of Regeneron’s Products); the extent to which the results from the research and development programs conducted by Regeneron and/or its collaborators or licensees may be replicated in other studies and/or lead to advancement of product candidates to clinical trials, therapeutic applications, or regulatory approval; unanticipated expenses; the costs of developing, producing, and selling products; the ability of Regeneron to meet any of its financial projections or guidance and changes to the assumptions underlying those projections or guidance; the potential for any license, collaboration, or supply agreement, including Regeneron’s agreements with Sanofi and Bayer (or their respective affiliated companies, as applicable), to be cancelled or terminated; the impact of public health outbreaks, epidemics, or pandemics on Regeneron’s business; and risks associated with litigation and other proceedings and government investigations relating to the Company and/or its operations (including the pending civil proceedings initiated or joined by the U.S. Department of Justice and the U.S. Attorney’s Office for the District of Massachusetts), risks associated with intellectual property of other parties and pending or future litigation relating thereto (including without limitation the patent litigation and other related proceedings relating to EYLEA® (aflibercept) Injection), the ultimate outcome of any such proceedings and investigations, and the impact any of the foregoing may have on Regeneron’s business, prospects, operating results, and financial condition. A more complete description of these and other material risks can be found in Regeneron’s filings with the U.S. Securities and Exchange Commission, including its Form 10-K for the year ended December 31, 2024 and its Form 10-Q for the quarterly period ended September 30, 2025. Any forward-looking statements are made based on management’s current beliefs and judgment, and the reader is cautioned not to rely on any forward-looking statements made by Regeneron. Regeneron does not undertake any obligation to update (publicly or otherwise) any forward-looking statement, including without limitation any financial projection or guidance, whether as a result of new information, future events, or otherwise.

Regeneron uses its media and investor relations website and social media outlets to publish important information about the Company, including information that may be deemed material to investors. Financial and other information about Regeneron is routinely posted and is accessible on Regeneron’s media and investor relations website (https://investor.regeneron.com) and its LinkedIn page (https://www.linkedin.com/company/regeneron-pharmaceuticals)

Sanofi Disclaimers or Forward-Looking Statements
This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include projections and estimates regarding the marketing and other potential of the product, or regarding potential future revenues from the product. Forward-looking statements are generally identified by the words “expects”, “anticipates”, “believes”, “intends”, “estimates”, “plans”, and similar expressions. Although Sanofi’s management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Sanofi, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, unexpected regulatory actions or delays, or government regulation generally, that could affect the availability or commercial potential of the product, the fact that product may not be commercially successful, the uncertainties inherent in research and development, including future clinical data and analysis of existing clinical data relating to the product, including post marketing, unexpected safety, quality or manufacturing issues, competition in general, risks associated with intellectual property and any related future litigation and the ultimate outcome of such litigation, and volatile economic and market conditions, and the impact that global crises may have on us, our customers, suppliers, vendors, and other business partners, and the financial condition of any one of them, as well as on our employees and on the global economy as a whole. The risks and uncertainties also include the uncertainties discussed or identified in the public filings with the SEC and the AMF made by Sanofi, including those listed under “Risk Factors” and “Cautionary Statement Regarding Forward-Looking Statements” in Sanofi’s annual report on Form 20-F for the year ended December 31, 2024. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements.

All trademarks mentioned in this press release are the property of the Sanofi group except for VelociSuite and Regeneron Genetics Center.

Regeneron Contacts: Media Relations Sharon Chen Tel: +1 914-847-1546 Sharon.Chen@regeneron.com	Investor Relations Mark Hudson Tel: +1 914-847-3482 Mark.Hudson@regeneron.com

Sanofi Contacts: Media Relations Sandrine Guendoul Tel: +33 6 25 09 14 25 Sandrine.Guendoul@sanofi.com	Investor Relations Thomas Kudsk Larsen Tel: +44 7545 513 693 Thomas.Larsen@sanofi.com

Evan Berland Tel: +1 215-432-0234 Evan.Berland@sanofi.com Léo Le Bourhis Tel: + 33 6 75 06 43 81 leo.lebourhis@sanofi.com Victor Rouault Tel: +33 6 70 93 71 40 Victor.Rouault@sanofi.com Timothy Gilbert Tel: +1 516-521-2929 Timothy.Gilbert@sanofi.com Léa Ubaldi Tel: + 33 6 30 19 66 46 lea.ubaldi@sanofi.com	Alizé Kaisserian Tel: +33 6 47 04 12 11 Alize.Kaisserian@sanofi.com Keita Browne Tel: +1 781-249-1766 Keita.Browne@sanofi.com Nathalie Pham Tel: +33 7 85 93 30 17 Nathalie.Pham@sanofi.com Thibaud Châtelet Tel: +33 6 80 80 89 90 Thibaud.Chatelet@sanofi.com Yun Li Tel: +33 6 84 00 90 72 Yun.Li3@sanofi.com

____________________
¹ Data on File

Dupixent® (dupilumab) Approved in Japan for Children Aged 6 to 11 Years with Bronchial Asthma

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Dupixent® (dupilumab) Approved in Japan for Children Aged 6 to 11 Years with Bronchial Asthma

Dupixent® (dupilumab) Approved in Japan for Children Aged 6 to 11 Years with Bronchial Asthma

Approval based on global Phase 3 program in children demonstrating Dupixent significantly reduced exacerbations (by 54% to 65%) and improved lung function (by 4.68% to 5.32%) compared to placebo

The approval in Japan is based on data from the overall population and those with a type 2 inflammation phenotype (defined by raised blood eosinophils and/or fractional exhaled nitric oxide) in VOYAGE, a global Phase 3 trial evaluating Dupixent in children aged 6 to 11 years with uncontrolled moderate-to-severe asthma. Additionally, data from EXCURSION, an open-label extension of VOYAGE that included a sub-study of exclusively Japanese pediatric patients supported the approval. In the VOYAGE trial, Dupixent added to standard-of-care asthma therapy significantly reduced severe exacerbations (by 54% to 65%, p<0.0001) and improved lung function (by 4.68% to 5.32%, p=0.0012, p=0.0009 and p=0.0036, respectively) in the overall population, those with type 2 inflammation, and those with raised blood eosinophils, compared to placebo. In the sub-study of Japanese pediatric patients, Dupixent improved lung function from baseline at 12 weeks and resulted in a low rate of severe asthma exacerbations over one year. The treatment-related adverse events most commonly reported with Dupixent were injection site reactions (erythema, edema and induration) in VOYAGE and fever, oral herpes, eosinophilia and injection site reactions (erythema and induration) in EXCURSION.

Asthma is one of the most common chronic diseases in children. Despite treatment with current standard-of-care inhaled corticosteroids and bronchodilators, children may continue to experience serious symptoms, such as coughing, wheezing and difficulty breathing. Additionally, impaired lung function in young children can have potentially long-lasting impacts, such as reduced lung growth and persistent airway obstruction, if not addressed early. Patients also may require the use of multiple courses of systemic corticosteroids that carry significant risks. Uncontrolled asthma can interfere with day-to-day activities, like sleeping, attending school and playing sports.

Dupixent has received regulatory approvals in more than 60 countries in one or more indications including certain patients with atopic dermatitis, asthma, CRSwNP, eosinophilic esophagitis (EoE), prurigo nodularis, CSU, COPD and bullous pemphigoid (BP) in different age populations. More than 1,300,000 patients are being treated with Dupixent globally.¹

U.S. INDICATIONS
DUPIXENT is a prescription medicine used:

to treat adults and children 6 months of age and older with moderate-to-severe eczema (atopic dermatitis or AD) that is not well controlled with prescription therapies used on the skin (topical), or who cannot use topical therapies. DUPIXENT can be used with or without topical corticosteroids. It is not known if DUPIXENT is safe and effective in children with AD under 6 months of age.
with other asthma medicines for the maintenance treatment of moderate-to-severe eosinophilic or oral steroid dependent asthma in adults and children 6 years of age and older whose asthma is not controlled with their current asthma medicines. DUPIXENT helps prevent severe asthma attacks (exacerbations) and can improve your breathing. DUPIXENT may also help reduce the amount of oral corticosteroids you need while preventing severe asthma attacks and improving your breathing. It is not known if DUPIXENT is safe and effective in children with asthma under 6 years of age.
with other medicines for the maintenance treatment of chronic rhinosinusitis with nasal polyps (CRSwNP) in adults and children 12 years of age and older whose disease is not controlled. It is not known if DUPIXENT is safe and effective in children with CRSwNP under 12 years of age.
to treat adults and children 1 year of age and older with eosinophilic esophagitis (EoE), who weigh at least 33 pounds (15 kg). It is not known if DUPIXENT is safe and effective in children with EoE under 1 year of age, or who weigh less than 33 pounds (15 kg).
to treat adults with prurigo nodularis (PN). It is not known if DUPIXENT is safe and effective in children with PN under 18 years of age.
with other medicines for the maintenance treatment of adults with inadequately controlled chronic obstructive pulmonary disease (COPD) and a high number of blood eosinophils (a type of white blood cell that may contribute to your COPD). DUPIXENT is used to reduce the number of flare-ups (the worsening of your COPD symptoms for several days) and can improve your breathing. It is not known if DUPIXENT is safe and effective in children with COPD under 18 years of age.
to treat adults and children 12 years of age and older with chronic spontaneous urticaria (CSU) who continue to have hives that are not controlled with H1 antihistamine treatment. It is not known if DUPIXENT is safe and effective in children with CSU under 12 years of age, or who weigh less than 66 pounds (30 kg).
to treat adults with bullous pemphigoid (BP). It is not known if DUPIXENT is safe and effective in children with BP under 18 years of age.

DUPIXENT is not used to relieve sudden breathing problems and will not replace an inhaled rescue medicine or to treat any other forms of hives (urticaria).

IMPORTANT SAFETY INFORMATION

Do not use if you are allergic to dupilumab or to any of the ingredients in DUPIXENT^®.

Before using DUPIXENT, tell your healthcare provider about all your medical conditions, including if you:

have eye problems.
have a parasitic (helminth) infection.
are scheduled to receive any vaccinations. You should not receive a “live vaccine” right before and during treatment with DUPIXENT.
are pregnant or plan to become pregnant. It is not known whether DUPIXENT will harm your unborn baby.
- A pregnancy registry for women who take DUPIXENT during pregnancy collects information about the health of you and your baby. To enroll or get more information call 1-877-311-8972 or go to https://mothertobaby.org/ongoing-study/dupixent/.
are breastfeeding or plan to breastfeed. It is not known whether DUPIXENT passes into your breast milk.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

DUPIXENT can cause serious side effects, including:

Allergic reactions. DUPIXENT can cause allergic reactions, including skin reactions, that can sometimes be severe. Stop using DUPIXENT and tell your healthcare provider or get emergency help right away if you get any of the following signs or symptoms: breathing problems or wheezing, swelling of the face, lips, mouth, tongue or throat, fainting, dizziness, feeling lightheaded, fast pulse, fever, hives, skin rash, including rash that looks like a bullseye, painful red or blue bumps under the skin, or red pus-filled spots on the skin, general ill feeling, itching, swollen lymph nodes, nausea or vomiting, joint pain, or cramps in your stomach area.
Eye problems. Tell your healthcare provider if you have any new or worsening eye problems, including eye pain or changes in vision, such as blurred vision. Your healthcare provider may send you to an ophthalmologist for an exam if needed.
Inflammation of your blood vessels. Rarely, this can happen in people with asthma who receive DUPIXENT. This may happen in people who also take a steroid medicine by mouth that is being stopped or the dose is being lowered. Tell your healthcare provider right away if you get: rash, chest pain, worsening shortness of breath, brown or dark colored urine, persistent fever, or a feeling of pins and needles or numbness of your arms or legs.
Psoriasis. This can happen in people with atopic dermatitis and asthma who receive DUPIXENT. Tell your healthcare provider about any new skin symptoms. Your healthcare provider may send you to a dermatologist for an examination if needed.
Joint aches and pain. Some people who use DUPIXENT have had trouble walking or moving due to their joint symptoms, and in some cases needed to be hospitalized. Tell your healthcare provider about any new or worsening joint symptoms. Your healthcare provider may stop DUPIXENT if you develop joint symptoms.

The most common side effects include:

Eczema: injection site reactions, eye problems, including eye and eyelid inflammation, redness, swelling, itching, eye infection, dry eye, and blurred vision, cold sores in your mouth or on your lips, and high count of a certain white blood cell (eosinophilia).
Asthma: injection site reactions, high count of a certain white blood cell (eosinophilia), pain in the throat (oropharyngeal pain), and parasitic (helminth) infections.
Chronic Rhinosinusitis with Nasal Polyps: injection site reactions, eye problems, including eye and eyelid inflammation, redness, swelling, itching, eye infection, and blurred vision, high count of a certain white blood cell (eosinophilia), stomach problems (gastritis), joint pain (arthralgia), trouble sleeping (insomnia), and toothache.
Eosinophilic Esophagitis: injection site reactions, upper respiratory tract infections, cold sores in your mouth or on your lips, and joint pain (arthralgia).
Prurigo Nodularis: eye problems, including eye and eyelid inflammation, redness, swelling, itching, and blurred vision, herpes virus infections, common cold symptoms (nasopharyngitis), dizziness, muscle pain, and diarrhea.
Chronic Obstructive Pulmonary Disease: injection site reactions, common cold symptoms (nasopharyngitis), high count of a certain white blood cell (eosinophilia), viral infection, back pain, inflammation inside the nose (rhinitis), diarrhea, stomach problems (gastritis), joint pain (arthralgia), toothache, headache, and urinary tract infection.
Chronic Spontaneous Urticaria: injection site reactions.
Bullous Pemphigoid: joint pain (arthralgia), eye problems, including eye and eyelid inflammation, redness, swelling, itching, and blurred vision, and herpes virus infections.

Please see accompanying full Prescribing Information including Patient Information.

For more information, please visit www.Regeneron.com or follow Regeneron on LinkedIn, Instagram, Facebook or X.

Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY

Regeneron Forward-Looking Statements and Use of Digital Media
This press release includes forward-looking statements that involve risks and uncertainties relating to future events and the future performance of Regeneron Pharmaceuticals, Inc. (“Regeneron” or the “Company”), and actual events or results may differ materially from these forward-looking statements. Words such as “anticipate,” “expect,” “intend,” “plan,” “believe,” “seek,” “estimate,” variations of such words, and similar expressions are intended to identify such forward-looking statements, although not all forward-looking statements contain these identifying words. These statements concern, and these risks and uncertainties include, among others, the nature, timing, and possible success and therapeutic applications of products marketed or otherwise commercialized by Regeneron and/or its collaborators or licensees (collectively, “Regeneron’s Products”) and product candidates being developed by Regeneron and/or its collaborators or licensees (collectively, “Regeneron’s Product Candidates”) and research and clinical programs now underway or planned, including without limitation Dupixent® (dupilumab) for the treatment of bronchial asthma in children aged 6 to 11 years pursuant to the approval by Japan’s Ministry of Health, Labour and Welfare (MHLW) discussed in this press release; the likelihood, timing, and scope of possible regulatory approval and commercial launch of Regeneron’s Product Candidates and new indications for Regeneron’s Products, including Dupixent for the treatment of chronic pruritus of unknown origin, lichen simplex chronicus, allergic fungal rhinosinusitis, and other potential indications; uncertainty of the utilization, market acceptance, and commercial success of Regeneron’s Products (such as Dupixent) and Regeneron’s Product Candidates and the impact of studies (whether conducted by Regeneron or others and whether mandated or voluntary), including the studies discussed or referenced in this press release, on any of the foregoing; the ability of Regeneron’s collaborators, licensees, suppliers, or other third parties (as applicable) to perform manufacturing, filling, finishing, packaging, labeling, distribution, and other steps related to Regeneron’s Products and Regeneron’s Product Candidates; the ability of Regeneron to manage supply chains for multiple products and product candidates and risks associated with tariffs and other trade restrictions; safety issues resulting from the administration of Regeneron’s Products (such as Dupixent) and Regeneron’s Product Candidates in patients, including serious complications or side effects in connection with the use of Regeneron’s Products and Regeneron’s Product Candidates in clinical trials; determinations by regulatory and administrative governmental authorities which may delay or restrict Regeneron’s ability to continue to develop or commercialize Regeneron’s Products and Regeneron’s Product Candidates; ongoing regulatory obligations and oversight impacting Regeneron’s Products, research and clinical programs, and business, including those relating to patient privacy; the availability and extent of reimbursement or copay assistance for Regeneron’s Products from third-party payors and other third parties, including private payor healthcare and insurance programs, health maintenance organizations, pharmacy benefit management companies, and government programs such as Medicare and Medicaid; coverage and reimbursement determinations by such payors and other third parties and new policies and procedures adopted by such payors and other third parties; changes to drug pricing regulations and requirements and Regeneron’s pricing strategy; other changes in laws, regulations, and policies affecting the healthcare industry; competing drugs and product candidates that may be superior to, or more cost effective than, Regeneron’s Products and Regeneron’s Product Candidates (including biosimilar versions of Regeneron’s Products); the extent to which the results from the research and development programs conducted by Regeneron and/or its collaborators or licensees may be replicated in other studies and/or lead to advancement of product candidates to clinical trials, therapeutic applications, or regulatory approval; unanticipated expenses; the costs of developing, producing, and selling products; the ability of Regeneron to meet any of its financial projections or guidance and changes to the assumptions underlying those projections or guidance; the potential for any license, collaboration, or supply agreement, including Regeneron’s agreements with Sanofi and Bayer (or their respective affiliated companies, as applicable), to be cancelled or terminated; the impact of public health outbreaks, epidemics, or pandemics on Regeneron’s business; and risks associated with litigation and other proceedings and government investigations relating to the Company and/or its operations (including the pending civil proceedings initiated or joined by the U.S. Department of Justice and the U.S. Attorney’s Office for the District of Massachusetts), risks associated with intellectual property of other parties and pending or future litigation relating thereto (including without limitation the patent litigation and other related proceedings relating to EYLEA® (aflibercept) Injection), the ultimate outcome of any such proceedings and investigations, and the impact any of the foregoing may have on Regeneron’s business, prospects, operating results, and financial condition. A more complete description of these and other material risks can be found in Regeneron’s filings with the U.S. Securities and Exchange Commission, including its Form 10-K for the year ended December 31, 2024 and its Form 10-Q for the quarterly period ended September 30, 2025. Any forward-looking statements are made based on management’s current beliefs and judgment, and the reader is cautioned not to rely on any forward-looking statements made by Regeneron. Regeneron does not undertake any obligation to update (publicly or otherwise) any forward-looking statement, including without limitation any financial projection or guidance, whether as a result of new information, future events, or otherwise.

Regeneron uses its media and investor relations website and social media outlets to publish important information about the Company, including information that may be deemed material to investors. Financial and other information about Regeneron is routinely posted and is accessible on Regeneron’s media and investor relations website (https://investor.regeneron.com) and its LinkedIn page (https://www.linkedin.com/company/regeneron-pharmaceuticals)

All trademarks mentioned in this press release are the property of the Sanofi group except for VelociSuite and Regeneron Genetics Center.

Regeneron Contacts: Media Relations Sharon Chen Tel: +1 914-847-1546 Sharon.Chen@regeneron.com	Investor Relations Mark Hudson Tel: +1 914-847-3482 Mark.Hudson@regeneron.com

Sanofi Contacts: Media Relations Sandrine Guendoul Tel: +33 6 25 09 14 25 Sandrine.Guendoul@sanofi.com	Investor Relations Thomas Kudsk Larsen Tel: +44 7545 513 693 Thomas.Larsen@sanofi.com

Evan Berland Tel: +1 215-432-0234 Evan.Berland@sanofi.com Léo Le Bourhis Tel: + 33 6 75 06 43 81 leo.lebourhis@sanofi.com Victor Rouault Tel: +33 6 70 93 71 40 Victor.Rouault@sanofi.com Timothy Gilbert Tel: +1 516-521-2929 Timothy.Gilbert@sanofi.com Léa Ubaldi Tel: + 33 6 30 19 66 46 lea.ubaldi@sanofi.com	Alizé Kaisserian Tel: +33 6 47 04 12 11 Alize.Kaisserian@sanofi.com Keita Browne Tel: +1 781-249-1766 Keita.Browne@sanofi.com Nathalie Pham Tel: +33 7 85 93 30 17 Nathalie.Pham@sanofi.com Thibaud Châtelet Tel: +33 6 80 80 89 90 Thibaud.Chatelet@sanofi.com Yun Li Tel: +33 6 84 00 90 72 Yun.Li3@sanofi.com

____________________
¹ Data on File

Burning Rock Announces Results of 2025 Annual General Meeting

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Burning Rock Announces Results of 2025 Annual General Meeting

Burning Rock Announces Results of 2025 Annual General Meeting

GUANGZHOU, China, Dec. 22, 2025 (GLOBE NEWSWIRE) — Burning Rock Biotech Limited (NASDAQ: BNR, the “Company” or “Burning Rock”), a company focusing on the application of next generation sequencing (NGS) technology in the field of precision oncology, today announced that all shareholder resolutions proposed at the Company’s 2025 annual general meeting held today were duly passed. Specifically, the shareholders passed the following resolutions:

as an ordinary resolution, THAT the appointment of Ernst & Young Hua Ming LLP as auditor of the Company for the fiscal year ending December 31, 2025 be ratified and that the directors of the Company be authorized to determine the remuneration of the auditor;
as an ordinary resolution, THAT Feng Deng and Licen Lisa Xu be re-elected as directors of the Company; and
as an ordinary resolution, THAT each of the directors of the Company be authorized to take any and all action that might be necessary to effect the foregoing resolutions as such director, in his or her absolute discretion, thinks fit.

About Burning Rock

Burning Rock Biotech Limited (NASDAQ: BNR), whose mission is to guard life via science, focuses on the application of next generation sequencing (NGS) technology in the field of precision oncology. Its business consists of i) NGS-based therapy selection testing for late-stage cancer patients, and ii) cancer early detection, which has moved beyond proof-of-concept R&D into the clinical validation stage.

For more information about Burning Rock, please visit: ir.brbiotech.com.

Contact: IR@brbiotech.com

Vireo Growth Inc. Enters California and Florida and Strengthens Delivery Platforms with Acquisition of Eaze Inc.

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Vireo Growth Inc. Enters California and Florida and Strengthens Delivery Platforms with Acquisition of Eaze Inc.

Vireo Growth Inc. Enters California and Florida and Strengthens Delivery Platforms with Acquisition of Eaze Inc.

Transaction will expand Vireo’s operating footprint to 10 states with 166 dispensaries and approximately 800,000 sq. ft. of cultivation and production

Acquisition also will add an incremental 14 dispensaries to Company’s retail footprint in Colorado

Eaze’s delivery platform will enhance Company’s IP portfolio with a robust presence in California

MINNEAPOLIS, Dec. 22, 2025 (GLOBE NEWSWIRE) — Vireo Growth Inc. (“Vireo”) (CSE: VREO; OTCQX: VREOF) (“Vireo” or the “Company”) today announced that it has entered into a definitive agreement to acquire Eaze Inc. (“Eaze”), a vertically-integrated cannabis retailer and delivery technology platform with operations in California, Florida and Colorado. Eaze has 65 active retail locations and has completed over 12 million deliveries.

The transaction marks Vireo’s entry into two of the country’s largest cannabis markets of California and Florida. Eaze has a robust presence in delivery sales in California with four co-located retail and delivery locations and eight delivery-only locations with coverage in most major metropolitan areas of the state. In Florida, Eaze is currently the sixth largest retailer with 39 active stores and approximately 64,000 square feet of cultivation canopy with substantial expansion capacity. Finally, the transaction will expand Vireo’s retail presence in Colorado with 14 additional dispensaries, increasing its total Colorado footprint to 55 stores. Upon closing, Vireo’s portfolio of cannabis brands and assets will span 10 total states, with 166 active retail dispensaries and approximately 800,000 sq. ft. of operational cannabis cultivation and production.

The transaction will be effected by way of a planned merger whereby Eaze will become a wholly-owned subsidiary of Vireo. Total consideration in the transaction includes approximately $47.0 million in base consideration, payable through the issuance of approximately 84 million subordinate voting shares of the Company at closing at a deemed issue price per share of US$0.56. Total consideration payable in the transaction will be subject to adjustment based on closing levels of cash, indebtedness, tax obligations and working capital adjustments, as well as the occurrence of certain other events by the closing date. The share consideration will be subject to the customary hold period under the rules of the Canadian Securities Exchange (the “Exchange”). Completion of the transaction is subject to customary conditions, including receipt of necessary approvals, and is expected to close during the first half of calendar year 2026.

Eaze may be entitled to earn-out consideration as of December 31, 2026, calculated as 3.84x adjusted EBITDA, less the closing consideration and adjusted for incremental debt, with any such earn-out payable in subordinate voting shares of the Company at a deemed price equal to the higher of $1.05 and the 20-day volume-weighted average price as of December 31, 2026, subject to the Exchange’s pricing policies.

The sellers of Eaze have each entered into voluntary share lock-up agreements pursuant to which the shares will be subject to transfer restrictions for an aggregate period ending on March 1, 2028. Under these agreements, 20% of the shares will be released from lock-up on each of March 1, 2027, June 1, 2027, September 1, 2027, December 1, 2027 and March 1, 2028, with the remaining shares subject to lock-up from closing until the applicable release date.

Chief Executive Officer John Mazarakis commented, “We are excited to announce the acquisition of Eaze and Vireo’s entrance into California and Florida. The addition of Eaze provides immediate scale in two of the country’s largest cannabis markets, and strengthens our position in Colorado.”

Cory Azzalino, Chief Executive Officer of Eaze Inc., added, “Joining Vireo marks an exciting next chapter for Eaze. Our shareholders and teams share a common vision for building scaled, best-in-class operations, and together we are well positioned to elevate retail and delivery experiences for customers across each market we serve.”

About Vireo Growth Inc.

Vireo was founded in 2014 as a pioneering medical cannabis company. Vireo is building a disciplined, strategically aligned, and execution-focused platform in the industry. This strategy drives our intense local market focus while leveraging the strength of a national portfolio. We are committed to hiring industry leaders and deploying capital and talent where we believe it will drive the most value. Vireo operates with a long-term mindset, a bias for action, and an unapologetic commitment to its customers, employees, shareholders, industry collaborators, and the communities it serves. For more information about Vireo, visit www.vireogrowth.com.

Contact Information

Joe Duxbury
Chief Accounting Officer
investor@vireogrowth.com
612-314-8995

Forward-Looking Statement Disclosure

This press release contains “forward-looking information” within the meaning of applicable United States and Canadian securities legislation. To the extent any forward-looking information in this press release constitutes “financial outlooks” within the meaning of applicable United States or Canadian securities laws, this information is being provided as preliminary financial results; the reader is cautioned that this information may not be appropriate for any other purpose and the reader should not place undue reliance on such financial outlooks. Forward-looking information contained in this press release may be identified by the use of words such as “should,” “believe,” “estimate,” “would,” “looking forward,” “may,” “continue,” “expect,” “expected,” “will,” “likely,” “subject to,” and variations of such words and phrases, or any statements or clauses containing verbs in any future tense and includes statements regarding the expectations around the proposed transactions involving Eaze and its assets, including the anticipated timing of the closing thereof and the expected benefits of the transaction to Vireo. These statements should not be read as guarantees of future performance or results. Forward-looking information includes both known and unknown risks, uncertainties, and other factors which may cause the actual results, performance, or achievements of the Company or its subsidiaries to be materially different from any future results, performance, or achievements expressed or implied by the forward-looking statements or information contained in this press release. Any presented financial outlooks, as with forward-looking information generally, are, without limitation, based on the assumptions and subject to various risks as set out herein and in our Annual Report on Form 10 K and our Quarterly Reports on Form 10 Q filed with the Securities Exchange Commission. Our actual financial position and results of operations may differ materially from management’s current expectations and, as a result, our revenue, EBITDA, Adjusted EBITDA, and cash on hand may differ materially from any values provided in this press release. Forward-looking information is based upon a number of estimates and assumptions of management, believed but not certain to be reasonable, in light of management’s experience and perception of trends, current conditions, and expected developments, as well as other factors relevant in the circumstances, including assumptions in respect of current and future market conditions, the current and future regulatory environment, and the availability of licenses, approvals and permits.

Although the Company believes that the expectations and assumptions on which such forward-looking information is based are reasonable, the reader should not place undue reliance on the forward-looking information because the Company can give no assurance that they will prove to be correct. Actual results and developments may differ materially from those contemplated by these statements. Forward-looking information is subject to a variety of risks and uncertainties that could cause actual events or results to differ materially from those projected in the forward-looking information. Such risks and uncertainties include, but are not limited to: risks involved with the adverse impact of the proposed transaction with Eaze on the Company’s business, financial condition, and results of operations; the Company’s ability to successfully consummate the transaction with Eaze; the Company’s ability to maintain relationships with suppliers, customers, employees and other third parties as a result of the proposed transaction with Eaze; the effects of the proposed transaction with Eaze on the Company and the interests of various constituents; risks and uncertainties associated with the proposed transaction with Eaze, some of which are beyond the Company’s control; subject to the successful outcome of the proposed transaction with Eaze, the nature, cost, impact and outcome of pending and future litigation, other legal or regulatory proceedings, or governmental investigations and actions;risks related to the timing and content of adult-use legislation in markets where the Company currently operates; current and future market conditions, including the market price of the subordinate voting shares of the Company; risks related to epidemics and pandemics; federal, state, local, and foreign government laws, rules, and regulations, including federal and state laws and regulations in the United States relating to cannabis operations in the United States and any changes to such laws or regulations; operational, regulatory and other risks; execution of business strategy; management of growth; difficulties inherent in forecasting future events; conflicts of interest; risks inherent in an agricultural business; risks inherent in a manufacturing business; liquidity and the ability of the Company to raise additional financing to continue as a going concern; the Company’s ability to meet the demand for flower in its various markets; our ability to dispose of our assets held for sale at an acceptable price or at all; and risk factors set out in the Company’s Annual Reports on Form 10 K and Quarterly Reports on Form 10 Q, which are available on EDGAR with the U.S. Securities and Exchange Commission and filed with the Canadian securities regulators and available under the Company’s profile on SEDAR+ at www.sedarplus.com.

The statements in this press release are made as of the date of this release. Except as required by law, we undertake no obligation to update any forward-looking statements or forward-looking information to reflect events or circumstances after the date of such statements.

Best Sermorelin Tablet for 2026? bmiMD Platform Lists Mint Sublingual Format at $79/Month as Peptide Wellness Interest Surges Before New Year

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Best Sermorelin Tablet for 2026? bmiMD Platform Lists Mint Sublingual Format at $79/Month as Peptide Wellness Interest Surges Before New Year

Best Sermorelin Tablet for 2026? bmiMD Platform Lists Mint Sublingual Format at $79/Month as Peptide Wellness Interest Surges Before New Year

Needle-Free Growth Hormone Support via Telehealth — Platform Analysis Compares Compounded Prescription Tablets vs. Injectable Format as Consumer Search Volume for “Sermorelin Alternative” Climbs 340% Year-Over-Year

NEW YORK, Dec. 22, 2025 (GLOBE NEWSWIRE) — Not Medical Advice: Read Before Proceeding This article is a market analysis for informational purposes only and does not constitute medical advice. “Best” in this context is defined by convenience, transparency, and access to services, not by clinical superiority or guaranteed health outcomes. Evaluation by a licensed clinician is required for sermorelin, and prescription approval is not guaranteed. Compounded medications are not FDA-approved; FDA does not verify their safety, effectiveness, or quality before they are marketed. Affiliate commissions may be earned, but do not impact the analysis. Always check current terms and consult a healthcare professional for medical questions.

Best Sermorelin Tablet for 2026_ bmiMD Platform Lists Mint Sublingual Format at $79_Month as Peptide Wellness Interest Surges Before New Year

If you’re researching sublingual sermorelin tablets for 2026—particularly as consumer interest in peptide-based wellness programs rises ahead of New Year wellness season—here are the key verification points before requesting a telehealth evaluation.

According to publicly available materials from bmiMD’s website, the platform offers sermorelin in mint-flavored sublingual tablet form, positioned as a needle-free alternative to injectable growth hormone-releasing peptides. Independent medical providers evaluate eligibility via telehealth intake, with prescriptions fulfilled by licensed compounding pharmacies.

This market analysis examines what distinguishes bmiMD’s sermorelin offering from a service-model perspective, what compounded medications are, what the regulatory landscape involves, and who this telehealth model may or may not align with.

Verify current bmiMD program details

Important context: According to the platform’s terms, sermorelin treatment is not intended to be prescribed for anti-aging, bodybuilding, or athletic performance—any use is provider-determined based on individual medical evaluation.

Quick Verification Checklist:

Provider independence: confirm (platform ≠ prescriber)
Compounded medication status disclosed upfront
Pharmacy licensing: verify via state board lookup
Refund/cancellation terms clear if prescription denied
Pricing transparency (promotional vs. regular rates)
Contraindications screening included in intake
Lab/testing requirements disclosed (or “no bloodwork” confirmed)

Why “Best Sermorelin Tablet” — Evaluation Criteria Disclosed
This analysis uses “best” based on defined, verifiable service-model factors—not subjective opinions or clinical outcome claims:

Format accessibility: Sublingual tablets (needle-free) vs. injectable sermorelin, per website materials

Provider separation transparency: According to the platform’s terms, bmiMD operates as a technology platform connecting users with independent medical providers—not prescribing medications itself

Compounding disclosure standards: Website materials explicitly state sermorelin is a compounded medication not FDA-approved as a finished product

Pricing transparency: According to the website, promotional pricing (from $79/month) and regular pricing ($139/month) listed in publicly available website materials

Telehealth accessibility: Entire process (intake, provider evaluation, prescription fulfillment, delivery) operates remotely according to website materials

Refund/cancellation clarity: Terms explicitly state prescription approval not guaranteed; authorization hold released if provider determines ineligibility

These factors represent program design and disclosure quality—not medical efficacy claims. Individual clinical appropriateness must be determined by a licensed provider based on personal health factors.

Verify current bmiMD program details

How bmiMD’s Sermorelin Service Operates: Three-Entity Structure
According to the platform’s terms of use, three separate entities are involved in bmiMD’s service—a structure that separates technology platform operations from clinical decision-making and medication dispensing:

bmiMD (Medccm Inc.) functions as the technology platform providing the website, intake process, customer service, and coordination infrastructure. According to the platform’s terms, bmiMD itself is not a healthcare provider and does not prescribe medications.

Independent Medical Providers are licensed healthcare professionals who review patient information submitted through the platform and determine whether prescriptions are appropriate. These providers make clinical decisions based on health information patients provide through telehealth intake questionnaires. The platform states that prescriptions are not guaranteed—the provider may determine sermorelin is not appropriate based on individual health factors.

Compounding Pharmacies (including Precision Compounding Pharmacy in Bellmore, NY, according to website materials, though bmiMD may use other state-appropriate pharmacies) fulfill prescriptions written by the medical providers. These are licensed 503A compounding pharmacies that prepare medications according to individual prescriptions.

What topics are discussed regarding sermorelin: According to bmiMD’s website, the platform positions sermorelin across four wellness categories: Weight Loss, Mood + Energy, Strength + Cardio, and healthy aging support. Materials describe topics including natural growth hormone production support, muscle maintenance, fat metabolism, sleep quality, and energy levels. These represent the brand’s therapeutic positioning—not verified outcomes guaranteed for all users.

Understanding Compounded Medications: What FDA Says

Before evaluating any sermorelin service, it’s essential to understand what “compounded medication” means—because this is fundamentally different from FDA-approved drugs.

According to FDA guidance: “Compounded drugs are not FDA-approved. FDA does not verify the safety, effectiveness, or quality of compounded drugs before they are marketed.” Compounding pharmacies are licensed facilities that prepare customized medications for individual patients based on prescriptions from licensed healthcare providers.

FDA notes compounded drugs are generally intended for situations where an FDA-approved option cannot meet a patient’s needs—such as when a patient requires a different dosage form, strength, or formulation not commercially available, or when a commercially manufactured drug has been discontinued.

Compounding is overseen under federal law and state pharmacy laws. FDA and state regulators share responsibility for oversight, and FDA maintains enforcement authority under applicable federal requirements. Compounded drugs are not FDA-approved, and FDA does not verify their safety, effectiveness, or quality before they are marketed.

What this means for sermorelin: No FDA-approved sermorelin product is currently marketed. As a result, compounded prescription preparations are one pathway clinicians may use when they determine it is appropriate for an individual patient.

According to bmiMD’s terms, the platform works with licensed 503A compounding pharmacies (including Precision Compounding Pharmacy in Bellmore, NY, per website materials) that prepare sermorelin based on individual prescriptions written by independent medical providers.

The Clinical Context: How Sermorelin Works and Why It’s Discussed for Wellness

Sermorelin is a growth hormone-releasing hormone (GHRH) analog—a synthetic peptide designed to mimic the natural hormone your hypothalamus produces to signal your pituitary gland to release growth hormone (GH).

The original FDA-approved indication: Sermorelin was never FDA-approved for wellness programs, muscle building, fat loss, or sleep improvement. Its original approval was specifically for diagnostic testing of growth hormone deficiency in children—used to stimulate GH release during diagnostic procedures.

Current off-label discussion: Healthcare providers may prescribe medications for uses other than their original FDA-approved indication based on clinical judgment, available research, and patient-specific factors. This is called “off-label” prescribing and is common across medicine. An estimated 20% of all prescriptions in the U.S. are written for off-label purposes.

The physiological rationale discussed in clinical literature:

Growth hormone plays multiple roles: protein synthesis and muscle maintenance, lipolysis (fat breakdown), bone density support, sleep architecture (GH is primarily released during deep sleep), and metabolic regulation. As people age, growth hormone production declines—a phenomenon sometimes called “somatopause.”

Research on GHRH peptides (including sermorelin) has explored effects on body composition, sleep quality, metabolic markers, and physical function in adults with age-related GH decline. Some studies have shown improvements in lean body mass, reductions in fat mass, enhanced sleep architecture, and positive effects on metabolic health markers in specific study populations.

Critical limitation: These are ingredient-level studies, often conducted in controlled research settings with specific populations. bmiMD’s sermorelin tablets as a finished compounded product have not been clinically studied for these outcomes. Individual results in real-world use vary significantly and are not guaranteed.

Sublingual Format vs. Injectable Sermorelin: What Differs

According to bmiMD’s website materials, the platform offers sermorelin in mint-flavored sublingual tablet form—tablets designed to dissolve under the tongue. This format represents a key differentiator from the more common injectable sermorelin delivery method.

Injectable Sermorelin (traditional format):

Administration via subcutaneous injection (typically abdomen or thigh)
Requires comfort with self-injection using insulin-style needles
Generally requires refrigeration after reconstitution
Well-established pharmacokinetic data from decades of clinical use
Supplies needed: needles, alcohol wipes, sharps disposal

Sublingual Tablets (bmiMD format):

Dissolve under tongue; absorbed through oral mucosa (per website materials)
No needles required
Simpler for daily routine
Less extensive published data on bioavailability compared to injectable

Bioavailability considerations: Sublingual dosing is intended to support absorption through the oral mucosa. However, published pharmacokinetic data comparing compounded sublingual sermorelin to injections is limited. Injectable sermorelin has more established research documentation.

The Telehealth Evaluation Process: “No Bloodwork Needed” Explained

According to bmiMD’s website, the platform advertises “No Bloodwork Needed” for sermorelin prescriptions. Here’s what this service design feature means in context:

Traditional clinical approach: Endocrinology or wellness clinics prescribing growth hormone therapy or GHRH peptides typically conduct diagnostic lab work including IGF-1 levels (a marker of GH activity), comprehensive metabolic panels, lipid panels, thyroid function tests, and sometimes GH stimulation tests. This establishes whether a patient has clinical deficiency and creates baseline data for monitoring.

bmiMD’s service design: According to website materials, bmiMD’s service is designed for individuals seeking wellness support. The prescribing provider evaluates health information through a telehealth intake questionnaire and determines appropriateness based on that assessment, without requiring upfront lab work as a standard protocol.

The step-by-step process described on the website:

Complete online intake form with health history, current medications, symptoms, wellness goals, and conditions
Provider review (typically within 24 hours per website materials)
Clinical determination—provider decides appropriateness; prescriptions not guaranteed
If prescription issued, sent to partner compounding pharmacy
Pharmacy compounds medication and ships directly

Important clarifications:

According to the terms, “no bloodwork needed” represents the service’s standard protocol—not an absolute prohibition. If the provider determines lab work is necessary for an individual case based on health history, they may request it.

The provider may decline to prescribe if health history includes contraindications (active cancer, pregnancy, nursing, certain metabolic conditions), medication interactions, or if submitted information raises clinical concerns.

According to the refund policy, if you’re not approved for prescription, you’re not charged—the system verifies eligibility before processing payment.

Pricing Structure and Subscription Terms

According to bmiMD’s website (pricing details reflect publicly available website materials at time of publication; verify current terms on bmiMD’s website before purchase), the website states sermorelin sublingual tablets are offered through subscription pricing:

3-Month Subscription (marked as “Best Value” per website materials):

First month: $79/month (promotional pricing per website)
Subsequent months: $139/month (per website)
Includes: 90 sublingual tablets total (30 per month) per website materials
Expedited shipping, US-based pharmacy formulation (per website)

Monthly Subscription:

Regular price: $139/month (per website)
Includes: 30 sublingual tablets (per website)
Free shipping per website materials

According to website materials, the subscription includes:

Regular consultations with bmiMD providers
24/7 provider access through patient portal
Wellness coaching included with 3-month programs

HSA/FSA Eligibility: According to a dedicated page on the website, bmiMD states prescription products including sermorelin may qualify as eligible medical expenses for Health Savings Account (HSA) and Flexible Spending Account (FSA) reimbursement. Website notes you can use HSA/FSA card at checkout or submit receipts afterward. Eligibility and coverage vary by plan provider—verify with your specific administrator.

Cancellation terms: According to website terms, subscriptions can be canceled or paused through the account portal, except if already charged for the next month. Prescriptions already processed and sent to pharmacy are non-refundable. A $50 cancellation fee applies if canceling after intake approval but before pharmacy processing.

Verify current terms: Pricing, promotions, and subscription details are subject to change. Always confirm current pricing and program terms directly on bmiMD’s website before purchase.

Verify current bmiMD program details

Who This Telehealth Model May or May Not Suit

Rather than relying on individual testimonials (which represent specific experiences and may not be typical), here’s a self-assessment framework to evaluate whether bmiMD’s sermorelin service aligns with your situation:

This telehealth model may align well with people who:

Prefer needle-free peptide delivery: Sublingual tablets eliminate injection requirements (per website materials)—no needles, avoids injection-site reactions associated with injections. If needle aversion has been your barrier to peptide therapy, this format addresses that obstacle.

Seek telehealth convenience: The entirely remote process (intake, consultation, prescription, delivery) eliminates geographic and scheduling barriers. If you lack access to wellness clinics in your area or can’t accommodate in-person appointments, this model provides accessibility.

Understand compounded medication distinctions: If you comprehend that compounded medications are not FDA-approved as finished products and are comfortable with this regulatory framework for wellness purposes under provider supervision, this service operates within that structure.

Have realistic timeline expectations: Changes discussed in clinical literature for GHRH peptides typically occur gradually over weeks to months with consistent use. If you’re seeking rapid transformation or guaranteed outcomes, that expectation doesn’t align with how these peptides generally function.

Value pricing transparency: According to website materials, promotional (from $79/month) and regular pricing ($139/month) are clearly disclosed during the checkout process.

Other approaches may be preferable for people who:

Prefer FDA-approved medications: If you specifically want FDA-approved therapies for wellness programs, compounded sermorelin doesn’t fit that preference. Other pathways may align better with your comfort level.

Want comprehensive lab monitoring: If you prefer thorough baseline lab testing (IGF-1 levels, metabolic panels) and ongoing monitoring to objectively track therapy effects and safety, traditional wellness clinics offer that clinical rigor. bmiMD’s “no bloodwork” standard protocol doesn’t provide that level of laboratory assessment.

Seek in-person medical evaluation: Telehealth offers convenience but limits hands-on physical examination. If you prefer face-to-face provider interaction and in-person clinical assessment, brick-and-mortar clinics provide that experience.

Want the most established delivery method: Injectable sermorelin has decades of pharmacokinetic research and clinical use documentation. Sublingual peptide delivery has less extensive published data. If you prioritize format with the most research backing, injectable may suit you better.

Have certain health conditions: According to website materials, certain individuals may not be eligible (for example: pregnancy/nursing, under 18, active malignancy). Eligibility is determined by the prescribing clinician based on individual health factors.

Questions to consider:

Do you understand the regulatory difference between compounded medications and FDA-approved drugs?
Are you comfortable with off-label use for wellness rather than diagnosed deficiency treatment?
Have you discussed peptide therapy with your primary care provider?
Do your wellness goals align with the gradual changes discussed in clinical literature for GHRH peptides?
Does the telehealth model (convenience) or the traditional clinic model (comprehensive assessment) better match your healthcare preferences?

Your answers help clarify whether bmiMD’s specific service design matches your health philosophy and preferences.

Timeline Expectations and Individual Variability

According to bmiMD’s product page, the platform states that sermorelin “may start showing effects within weeks of consistent use.” This appropriately acknowledges variability—individual response to GHRH peptides varies significantly.

Based on clinical literature discussing GHRH peptides generally, people using sermorelin may notice changes along rough patterns, though individual experiences differ widely:

First few weeks: Some people in clinical contexts report improved sleep quality as an early change—deeper sleep, better rest quality, or more consistent sleep patterns. Others notice no sleep changes. Energy level stabilization may occur for some during this timeframe.

Around 4-8 weeks: If body composition changes occur, this is typically when subtle shifts may begin—clothes fitting differently, minor changes in muscle definition, gradual fat loss patterns (particularly midsection). When these changes occur, they’re usually gradual rather than dramatic.

2-3 months: Continued body composition changes may become more apparent for those who respond. Some clinical literature discusses improvements in exercise recovery—reduced muscle soreness, improved endurance. Skin quality changes (thickness, elasticity, hydration) are sometimes discussed during this timeframe in clinical contexts, though effects when they occur are typically subtle.

Important caveats:

Many people don’t notice dramatic changes. Growth hormone support is not like stimulant medication with immediately obvious effects. Benefits when they occur are often gradual, subtle, and may be difficult to distinguish from other lifestyle factors (diet, exercise, sleep hygiene, stress management).

Individual response varies based on: baseline starting point (age, current hormone levels, body composition), consistency of use and timing, lifestyle factors (diet quality, exercise routine, sleep habits, stress levels), genetic factors affecting hormone receptor sensitivity, other medications or supplements, and the specific compounded formulation.

Results are not guaranteed. Topics discussed on bmiMD’s website represent what the platform positions sermorelin to support—not guaranteed outcomes for all users.

Safety Profile and Clinical Considerations

According to medical literature and bmiMD’s website materials, sermorelin is generally well-tolerated when used as directed under medical supervision. The following points are a high-level overview, not a complete list of risks or precautions.

Common effects when they occur (based on medical literature):

For injectable forms (not applicable to sublingual tablets): injection site reactions such as redness, swelling, or pain. For sublingual administration: altered taste, flushing or warmth in face or body, mild headache (typically transient), dizziness or lightheadedness (usually temporary), nausea (generally mild when it occurs).

Most effects when they occur are mild and typically diminish as the body adjusts. If effects persist or become bothersome, contact your prescribing provider.

Contraindications according to website materials and medical literature:

People with certain conditions may not be eligible for sermorelin; the prescribing clinician determines eligibility based on individual risk factors. Conditions that may affect eligibility include active malignancy or other significant medical history, pregnancy or nursing (safety not established), age under 18 (unless specifically prescribed for diagnosed GH deficiency under endocrinology care), or hypersensitivity to sermorelin or formulation ingredients.

Use with caution if you have: diabetes or impaired glucose tolerance (growth hormone affects insulin sensitivity and glucose metabolism; monitor blood sugar closely), thyroid disorders (GH therapy can affect thyroid function; may require thyroid medication adjustment), pituitary disorders or history of brain tumors, cardiovascular disease (growth hormone affects cardiac function and fluid balance).

Drug interactions: Growth hormone-releasing peptides may interact with insulin and diabetes medications (GH can affect insulin sensitivity), thyroid medications (GH may alter thyroid hormone levels), and corticosteroids (may blunt GH response to sermorelin).

Always inform your prescribing provider about all medications, supplements, and health conditions during your intake consultation.

This safety overview is not exhaustive and does not replace Patient Drug Education or official prescribing information. Always review full safety information that comes with your prescription and consult your prescriber or pharmacist with questions.

This is not a replacement for prescribed medical treatment for any health condition. Always consult your physician if you have health concerns, take other medications, or have questions before starting sermorelin or any prescription treatment.

Contact Information

For questions before or during use of bmiMD’s service, according to the company’s website, customer support is available at:

Email: orders@bmimd.com
Address: 420 Lexington Ave, Suite 1402, New York, NY 10170

Market Analysis Summary: Balancing Convenience Against Clinical Rigor
After reviewing bmiMD’s sermorelin tablet service structure, here’s the balanced assessment based on disclosed program factors:
Service Design Strengths:

Format addresses real adoption barriers: Sublingual tablet format eliminates needle requirements—a genuine obstacle for many people interested in peptide therapy. If injection aversion has prevented you from exploring GHRH peptides, this delivery method removes that barrier.

Pricing positioned below traditional clinic models: At $139/month regular pricing (or from $79/month promotional per website materials), bmiMD positions below typical wellness clinic ranges of $200-$600/month, particularly when factoring in eliminated lab costs and clinic visit fees.

Transparency about regulatory framework: The website explicitly discloses that sermorelin is a compounded medication not FDA-approved as a finished product, and that bmiMD operates as a platform connecting users with independent providers rather than prescribing medications itself. This disclosure standard exceeds some peptide vendors operating in less transparent regulatory zones.

Telehealth accessibility: The entirely remote model (intake, consultation, prescription, delivery) eliminates geographic barriers for people in areas without access to specialized wellness clinics.

Considerations to Weigh:

Compounded medication framework: You’re receiving a product that FDA has not evaluated for safety, effectiveness, or quality as a finished medication. This is legal under compounding regulations, but represents a different regulatory standard than FDA-approved drugs.

“No bloodwork” model reduces clinical data: While convenient, the standard protocol of skipping baseline lab work means you lack objective markers (IGF-1 levels, metabolic panels) to monitor therapy effectiveness or safety over time. You’re relying on subjective assessment rather than laboratory data.

Off-label use for purposes beyond original indication: Sermorelin was never FDA-approved for wellness programs, muscle building, or fat loss applications. You’re using it for purposes beyond its original approved diagnostic indication, based on ingredient-level research and off-label prescribing patterns—not FDA-reviewed efficacy data for these specific uses. According to the platform’s terms, treatment is not intended to be prescribed for anti-aging, bodybuilding, or athletic performance—any use is provider-determined based on individual medical evaluation.

Sublingual bioavailability less documented: Injectable sermorelin has decades of pharmacokinetic research. Sublingual peptide delivery has limited published bioavailability data. You’re prioritizing convenience over established absorption profiles.

Realistic expectations essential: If you expect rapid, dramatic transformation, disconnect exists between those expectations and how GHRH peptides typically function. Changes when they occur are gradual, subtle, and highly variable—and don’t occur for everyone despite consistent use.

Important Note: Growth hormone peptides have been under increased regulatory scrutiny in recent years, particularly when marketed for wellness programs or performance enhancement. Individuals should review current information about any compounded prescription service’s compliance and regulatory standing before proceeding.

The Bottom Line:

bmiMD’s sermorelin tablets represent a lower-barrier entry point into GHRH peptide therapy for people who understand they’re using a compounded medication for provider-determined wellness purposes, prefer convenience and needle-free format over comprehensive clinical assessment, have realistic expectations about gradual subtle changes rather than dramatic transformation, and are comfortable with the regulatory distinctions between compounded and FDA-approved medications.

This is not a rapid transformation solution. It’s a tool that may support wellness goals when used consistently under medical supervision, with full understanding of the regulatory framework and realistic expectations about individual variability in response.

Verify current bmiMD program details

Disclaimers

Content and Medical Disclaimer: This article is for informational and market analysis purposes only and is not a substitute for professional medical advice, diagnosis, or treatment. Topics discussed regarding potential applications are based on publicly available materials and general medical literature—not guarantees of individual outcomes. Sermorelin is a compounded prescription medication that requires evaluation by a licensed clinician. The information provided here does not replace the professional judgment of your healthcare provider.

Professional Medical Disclaimer: This article is educational and does not constitute medical advice. Sermorelin is not a substitute for prescribed medical treatment. If you are currently taking medications, have existing health conditions, are pregnant or nursing, or are considering any major changes to your health regimen, consult your physician before starting sermorelin or any new prescription treatment. Do not change, adjust, or discontinue any medications or prescribed treatments without your physician’s guidance and approval.

Compounded Medication Notice: Sermorelin tablets discussed in this analysis are compounded prescription medications prepared by licensed pharmacies based on individual prescriptions. According to FDA guidance: “Compounded drugs are not FDA-approved. FDA does not verify the safety, effectiveness, or quality of compounded drugs before they are marketed.” They are prepared by licensed pharmacies based on an individual prescription and dispensed under applicable federal and state pharmacy oversight.

Platform and Provider Separation: bmiMD (Medccm Inc.) is a technology platform and is not itself a healthcare provider. Independent medical providers review patient information and determine whether prescriptions are appropriate. Prescriptions are fulfilled by licensed compounding pharmacies. bmiMD does not control or influence the practice of medicine by the medical providers, each of whom is solely responsible for the medical care and treatment provided.

Results May Vary: Individual results will vary based on factors including age, baseline health condition, genetic factors, consistency of use, lifestyle factors, current medications, and other individual variables. Topics discussed regarding potential applications are based on general medical literature and ingredient-level research—not clinical trials of the specific compounded product. Results are not guaranteed.

Off-Label Use: Sermorelin was originally FDA-approved for a limited pediatric diagnostic indication and is no longer marketed as an FDA-approved finished drug product. Discussion of wellness-related use reflects clinician-directed, case-by-case prescribing judgment (off-label), not FDA-approved indications. According to the platform’s terms, treatment is not intended to be prescribed for anti-aging, bodybuilding, or athletic performance.

FTC Affiliate Disclosure: This article contains affiliate links. If you purchase through these links, a commission may be earned at no additional cost to you. This compensation does not influence the accuracy, neutrality, or integrity of the information presented. All analysis is based on publicly available information.

Pricing Disclaimer: All prices, discounts, and promotional offers mentioned were based on publicly available website information at the time of publication and are subject to change without notice. Always verify current pricing and terms on the official bmiMD website before making purchase decisions.

Publisher Responsibility: The publisher of this article has made every effort to ensure accuracy at the time of publication based on publicly available information. We do not accept responsibility for errors, omissions, or outcomes resulting from the use of the information provided. Readers are encouraged to verify all details directly with bmiMD and their healthcare provider before making decisions.

HSA/FSA Note: According to bmiMD’s website, prescription products may be eligible for HSA/FSA reimbursement, but coverage policies vary by plan. Always confirm benefits directly with your HSA/FSA plan administrator before purchase.

Regulatory Scrutiny Notice: Growth hormone peptides have been subject to increased regulatory attention from FDA and FTC in recent years. Users should stay informed about current regulatory developments affecting compounded peptide therapies and verify provider and pharmacy licensing in their state.

CONTACT: Email: orders@bmimd.com

Best GLP-1 Gummies for 2026: Akkermansia Probiotic Supplements for Weight Loss – Industry Analysis

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Best GLP-1 Gummies for 2026: Akkermansia Probiotic Supplements for Weight Loss – Industry Analysis

Best GLP-1 Gummies for 2026: Akkermansia Probiotic Supplements for Weight Loss – Industry Analysis

Analysis Examines GlucoBooster GLP-1 Gummies and Akkermansia-Based Probiotic Category Ahead of 2026 Weight-Loss Season – Ingredient Research, Regulatory Context, and Evidence Gaps Explained

New York, Dec. 22, 2025 (GLOBE NEWSWIRE) — Disclaimer: This article is for informational purposes only and does not constitute medical advice. Consult a qualified healthcare professional before starting supplements, especially if you have health conditions or take medications.

Affiliate Disclosure: This article may contain affiliate links. If you purchase through links in this article, a commission may be earned at no additional cost to you.

Best GLP-1 Gummies for 2026 Akkermansia Probiotic Supplements for Weight Loss Industry Analysis

This industry analysis reviews the science and regulatory context behind “GLP-1 gummy” marketing—what ingredient research suggests, what it does not prove, and how consumers can evaluate claims responsibly.

As 2026 approaches, consumer interest in non-prescription weight-support supplements continues to expand, including products marketed as supporting natural GLP-1 pathways. As industry analysis reveals probiotic Akkermansia formulas emerging as options for consumers seeking non-prescription approaches, this article examines the category through publicly available research and regulatory context, with emphasis on how to interpret supplement marketing claims without confusing them with prescription drug evidence.

View manufacturer information and current terms

Market Context: Why GLP-1 Gummies Are Trending Into 2026

Before examining the science, it’s essential to understand what consumers are actually buying when they purchase “GLP-1 gummies” compared to prescription GLP-1 medications. These products are often compared by consumers to prescription GLP-1 medications, but they are not FDA-approved drugs, are not clinically equivalent to GLP-1 receptor agonists, and ingredient-level research differs significantly from finished-product trials.

Prescription GLP-1 Medications

Drugs like Ozempic, Wegovy, and Mounjaro contain synthetic GLP-1 receptor agonists—pharmaceutical compounds that directly activate the same receptors natural GLP-1 activates. These medications are FDA-approved specifically for type 2 diabetes management or chronic weight loss, requiring prescriptions after medical evaluation and administered via weekly or daily injections.

Clinical trial data for prescription GLP-1 medications shows average body weight reduction of 15-20 percent over 68 weeks in controlled studies. Monthly costs without insurance typically range from $900 to $1,500, though insurance coverage can reduce out-of-pocket expenses to $25-$50 per month when covered. Common side effects include nausea, vomiting, diarrhea, and constipation, with potential serious risks including pancreatitis and gallbladder disease.

GLP-1 Supplement Gummies

Products marketed as GLP-1 gummies are classified as dietary supplements under FDA regulations. These products contain ingredients that companies claim may support the body’s natural GLP-1 production, but they are not FDA-approved drugs and have not undergone the clinical trial requirements that pharmaceutical medications face.

According to regulatory frameworks governing dietary supplements, these products do not require FDA approval before marketing. Manufacturers are responsible for ensuring safety and accurate labeling, but finished supplement formulas are not tested by the FDA for effectiveness. The distinction between “supporting natural GLP-1 production” and “providing synthetic GLP-1 receptor agonists” is fundamental—these are completely different mechanisms operating at different scales.

This is ingredient-level research; finished GLP-1 supplement products as complete formulas have not been clinically studied in the way prescription medications have been tested. The company claims about natural GLP-1 support represent their marketing positioning and have not been evaluated by the FDA as finished products.

Education: Prescription GLP-1 vs Supplements – The Evidence Gap

Understanding the evidence gap between pharmaceutical interventions and dietary supplements is critical for realistic expectations.

Efficacy: What Clinical Trials Show

Prescription GLP-1 medications have been tested in multiple phase 3 clinical trials involving thousands of participants over 68-week periods. Average weight loss with semaglutide in the STEP trials was approximately 15-20 percent of body weight. These medications work through direct activation of GLP-1 receptors with synthetic hormones that remain active in the body for extended periods.

Probiotic GLP-1 supplements have not been tested in comparable large-scale, long-duration clinical trials as finished products. Ingredient-level research on strains like Akkermansia shows associations with improved metabolic markers and modest weight changes—typically 1-2 kilograms over 3 months in the most robust studies. The mechanism involves potentially supporting natural GLP-1 production indirectly through gut health improvements, which produces effects within normal physiological ranges. Finished GLP-1 gummy products have not been studied in large randomized controlled trials. Ingredient studies do not equal product efficacy, and outcomes are not predictable.

The magnitude of effect differs substantially. Prescription medications produce dramatic, clinically significant weight loss in controlled trials. Dietary supplements with metabolic support ingredients may provide modest benefit when combined with lifestyle changes, but effects are substantially smaller and highly individual.

Cost Comparison

According to typical pricing, prescription GLP-1 medications without insurance cost $900-$1,500 per month, though insurance coverage can reduce copays to $25-$50 monthly when covered for diabetes management. Weight loss indications often face insurance coverage challenges.

Probiotic GLP-1 supplements range from $40-$80 per month depending on brand and package size. For consumers without insurance coverage for prescription medications, supplements offer significantly more affordable access—though affordability should not be confused with comparable effectiveness.

Actual costs vary by location, provider, and insurance. These ranges are general illustrative examples based on typical out-of-pocket pricing and are not specific to any particular practice or insurer.

Safety Profiles

Prescription GLP-1 medications carry well-documented side effect profiles. Nausea affects 40-50 percent of users, with vomiting, diarrhea, constipation, and abdominal pain also common. Serious risks include potential increased risk of pancreatitis, gallbladder disease, and thyroid tumors in animal studies. Contraindications include personal or family history of medullary thyroid carcinoma and multiple endocrine neoplasia syndrome type 2.

Probiotic supplements are generally well-tolerated by most healthy adults. Potential side effects typically include mild digestive changes during the adjustment period—gas, bloating, and bowel habit changes that usually resolve within 1-2 weeks. Serious risks are rare but possible in immunocompromised individuals or those with severe underlying health conditions.

The statement that any product has “no side effects” is inaccurate. While probiotics have a generally favorable safety profile, individual reactions vary. Some people experience digestive discomfort, and rare serious infections have been reported in severely immunocompromised patients.

Always consult your physician before starting any supplement, especially if you take blood sugar medications—probiotics may affect glucose metabolism—have immune system disorders, have digestive disorders, are pregnant or nursing, or take other medications.

Science: Akkermansia and GLP-1 Pathways – Limits Clearly Stated

The key scientific question: Is there legitimate research supporting the idea that certain probiotic strains can influence GLP-1 production? The answer is yes—but with important caveats about what that research shows and doesn’t show.

Akkermansia Muciniphila: The Most Studied Probiotic Strain

Akkermansia muciniphila is a gut bacteria strain that has received significant research attention in recent years for its potential role in metabolic health. This strain represents the primary scientific foundation cited by most probiotic GLP-1 supplements.

A 2019 study published in Nature Medicine examined Akkermansia supplementation in overweight and obese insulin-resistant volunteers. The randomized, double-blind trial found that daily supplementation with pasteurized Akkermansia muciniphila for three months resulted in reduced insulin resistance, decreased plasma total cholesterol, and modest improvements in body weight and fat mass compared to placebo. Importantly, the study found that pasteurized—heat-treated—Akkermansia was more effective than live bacteria, suggesting mechanisms may involve bacterial components rather than colonization.

Research published in PNAS in 2013 found that Akkermansia supplementation in obese mice increased gut levels of endocannabinoids that control inflammation, glucose metabolism, and gut barrier integrity—factors that influence GLP-1 secreting cells. A 2021 review in Gut Microbes summarized evidence that Akkermansia abundance is inversely correlated with obesity and metabolic dysfunction.

The GLP-1 connection is indirect. Research suggests Akkermansia may influence GLP-1 secretion through improvements in gut barrier function and reduction of inflammation rather than directly stimulating GLP-1 production. Most robust Akkermansia studies involved doses of 10 billion CFU daily, with weight loss effects in human trials described as modest—typically 1-2 kilograms over three months.

Individual response varies significantly based on baseline gut microbiome composition, diet quality, and genetic factors. What works for one person may provide minimal benefit for another.

Clostridium Butyricum: The Butyrate Producer

Clostridium butyricum is a probiotic strain that produces butyrate, a short-chain fatty acid with metabolic effects. Butyrate is known to stimulate GLP-1 secretion from intestinal L-cells through activation of specific receptors.

A 2016 study in Diabetes demonstrated that butyrate supplementation increased GLP-1 production and improved insulin sensitivity in mice. A 2019 systematic review in Nutrients examined Clostridium butyricum supplementation across multiple studies, finding evidence for improved gut barrier function, reduced inflammation markers, and support for beneficial gut microbiota composition.

Human studies have been more limited. A 2015 study in Beneficial Microbes found that C. butyricum supplementation improved constipation and overall gut health markers in elderly patients, though weight loss was not measured. The mechanism operates primarily through butyrate production, which acts on receptors that can stimulate GLP-1 secretion—though the magnitude of this effect in humans and whether it translates to meaningful appetite suppression remains unclear.

Bifidobacterium Infantis: The Inflammation Modulator

Bifidobacterium infantis is a well-studied probiotic strain primarily researched for digestive health and immune function. A 2016 study in Beneficial Microbes found that B. infantis supplementation improved symptoms in irritable bowel syndrome patients and reduced inflammatory markers.

The connection to GLP-1 and weight loss is indirect. By reducing gut inflammation and supporting intestinal barrier function, B. infantis may create an environment more conducive to metabolic health. However, direct evidence linking B. infantis to GLP-1 secretion or weight loss in humans is limited. Research on B. infantis has focused primarily on digestive health rather than weight management.

This is ingredient-level research; GLP-1 supplement gummies as finished products have not been clinically studied at the dosages and combinations used by commercial brands.

Regulatory Context: DSHEA and FTC Standards

The dietary supplement industry, particularly products making weight management and metabolic support claims, has been under increased FDA scrutiny in recent years. Consumers should review the most current information about any supplement’s ingredient sourcing, manufacturing standards, and claim substantiation before purchasing.

Recent regulatory developments include increased FDA enforcement actions against supplements making drug-like claims, FTC scrutiny of weight loss advertising focusing on substantiation of efficacy claims, and concern about supplements marketed as alternatives to prescription medications without adequate evidence.

Products in the GLP-1 supplement category position themselves as supporting natural hormone production rather than replacing pharmaceutical interventions. However, marketing language sometimes blurs this distinction, creating potential consumer confusion about what these products can actually deliver.

Important Regulatory Reminders:

Dietary supplements are not FDA-approved for treating medical conditions. The burden of proof for safety and accurate labeling rests with manufacturers, not regulatory agencies. Structure-function claims on supplement labels—statements about supporting body systems—do not require FDA approval, but disease claims would require drug approval processes. Marketing claims made outside product labels, such as on websites or in advertisements, fall under FTC jurisdiction for truth in advertising.

When evaluating any supplement claiming to support GLP-1 function, weight management, or metabolic health, consumers should verify company transparency about ingredient sourcing and dosing, look for third-party testing certifications like NSF or USP, understand that testimonials represent individual experiences and are not typical results guaranteed, recognize that past performance or reviews do not predict individual outcomes, and consult healthcare providers before starting any supplement regimen, especially with existing health conditions.

The claims made by probiotic GLP-1 supplement brands about natural hormone support represent their marketing positioning. These claims have not been evaluated by the FDA as finished products.

How to Evaluate “GLP-1 Gummy” Claims Responsibly

Consumers should distinguish between (1) prescription GLP-1 receptor agonists, which have extensive clinical trial evidence, and (2) dietary supplements that cite ingredient research but typically lack finished-product trials. Look for clear dosing disclosure, third-party testing transparency, and avoidance of drug-like promises. These supplements are not FDA-approved for weight loss and should not be treated as substitutes for medical care.

Questions to Ask a Healthcare Professional:

What are my health goals? Are you looking for modest support alongside lifestyle changes, or do you need clinically significant weight loss for health reasons?
What does my doctor recommend? Have you discussed your weight management goals with your healthcare provider? Do they recommend medical interventions, lifestyle modification, or both?
What’s my budget? Can you afford $40-$80 per month for a supplement with limited finished-product evidence, or would those funds be better spent on other interventions like nutrition counseling, gym membership, or mental health support?
What’s my risk tolerance? Are you comfortable trying a supplement approach knowing it may not work, or do you want the higher probability of success that comes with prescription medications?
What’s my timeline? Do you need relatively rapid results for health reasons such as surgery preparation or managing diabetes complications, or are you taking a long-term gradual approach?

Your answers help determine which weight management characteristics matter most for your specific situation.

Setting Realistic Expectations

No supplement—whether prescription or over-the-counter—produces significant sustained weight loss without behavioral changes. Even prescription GLP-1 medications work primarily by reducing appetite, making it easier to eat less. The medication doesn’t burn fat or magically make weight disappear. It suppresses hunger signals so that maintaining a calorie deficit feels less difficult.

Probiotic GLP-1 supplements, if they work through their claimed mechanisms, would operate similarly—potentially making it somewhat easier to manage portions and reduce cravings. But you still need to eat in a calorie deficit for weight loss, choose nutrient-dense whole foods most of the time, get regular physical activity including both cardio and strength training, get adequate sleep since poor sleep disrupts appetite hormones, manage stress as chronic stress elevates cortisol and promotes fat storage, and address emotional or behavioral eating patterns.

Supplements can support these efforts, but they cannot replace them.

Examples of Products in the Category (Non-Comparative)

Some dietary supplements marketed as “GLP-1 gummies” reference probiotics (including Akkermansia strains), fibers, polyphenols, or botanical extracts. Examples of brands marketed in this category have included GlucoBooster and Lemme GLP-1 Daily, alongside numerous third-party marketplace listings. Brands are listed as examples only; inclusion is not an endorsement, ranking, or comparison.

For product-specific details, readers should consult manufacturer information directly

Summary and Key Takeaways

As consumers enter the New Year weight loss season for 2026, the GLP-1 supplement market presents both opportunities and challenges.

What the Evidence Supports: Ingredient-level research on strains like Akkermansia muciniphila shows associations with improved metabolic markers in some studies. Probiotic supplementation can support overall gut health, which plays a role in metabolic function. Some individuals may experience modest benefits from metabolic support supplements when combined with lifestyle changes. The safety profile of probiotics is generally favorable for healthy adults.

What the Evidence Does Not Support: Finished probiotic GLP-1 supplement products have not been tested in large-scale, long-duration clinical trials comparable to pharmaceutical research. Weight loss effects comparable to prescription GLP-1 medications are not substantiated by supplement research. Dosages used in commercial products are often substantially lower than those studied in clinical research. Individual variability in response is high, with no way to predict who will benefit.

Making an Informed Decision: For people seeking affordable, accessible approaches to metabolic support who understand the evidence limitations and have realistic expectations about modest potential benefits, probiotic GLP-1 supplements represent one option in a comprehensive wellness strategy. Products should be evaluated based on ingredient quality and dosing, third-party testing and manufacturing standards, company transparency about pricing and terms, realistic marketing claims that acknowledge evidence limitations, and clear return policies and customer support access.

For people who need clinically proven interventions for obesity or metabolic disease, prescription medications remain the gold standard with the strongest evidence base. No dietary supplement currently matches the efficacy demonstrated by pharmaceutical GLP-1 receptor agonists in controlled clinical trials.

The best approach for most people heading into 2026: Focus on building a solid foundation of whole-food nutrition, regular physical activity, adequate sleep, and stress management. If you choose to add supplements, view them as potential modest enhancers, not replacements for that essential foundation.

Contact Information:

Company: GlucoBooster

Phone Support: +1-866-637-2482

Disclaimer

FDA Health Disclaimer: These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease. Always consult your physician before starting any new supplement, especially if you have existing health conditions, take medications, or are pregnant or nursing.

Professional Medical Disclaimer: This article is educational and does not constitute medical advice. Probiotic GLP-1 supplements are dietary supplements, not medications. If you are currently taking medications, have existing health conditions, are pregnant or nursing, or are considering any major changes to your health regimen, consult your physician before starting any new supplement. Do not change, adjust, or discontinue any medications or prescribed treatments without your physician’s guidance and approval.

Results May Vary: Individual results will vary based on factors including age, baseline weight and metabolic health, diet quality, exercise habits, sleep patterns, stress levels, gut microbiome composition, genetic factors, current medications, consistency of use, and other individual variables. While some customers report improvements, results are not guaranteed. The weight loss percentages and timelines mentioned in various brand marketing materials represent their projections and are not substantiated by clinical trials of finished products.

FTC Affiliate Disclosure: This article contains affiliate links. If you purchase through these links, a commission may be earned at no additional cost to you. This compensation does not influence the accuracy, neutrality, or integrity of the information presented. All opinions and descriptions are based on publicly available information, ingredient-level research, and brand marketing materials.

Pricing Disclaimer: All prices, discounts, package options, and subscription terms mentioned were accurate at the time of publication in December 2025 but are subject to change without notice. Always verify current pricing, shipping costs, subscription terms, and refund policies on official brand websites before making purchases.

Publisher Responsibility Disclaimer: The publisher of this article has made every effort to ensure accuracy at the time of publication. We do not accept responsibility for errors, omissions, changes to product formulations, changes to company policies, or outcomes resulting from the use of the information provided. Readers are encouraged to verify all details directly with brand customer service and their healthcare provider before making decisions.

Product Claims Disclaimer: All product features, benefits, ingredients, dosages, and efficacy claims are attributed to brand marketing materials and have not been independently verified by the publisher. Probiotic GLP-1 supplements as finished products have not been studied in published randomized controlled trials comparable to pharmaceutical research. Ingredient-level research cited reflects studies on individual ingredients, not specific commercial formulations. Brand positioning of these products as supporting natural GLP-1 production represents their marketing claims and has not been evaluated by the FDA. The publisher does not verify these claims, and results are not guaranteed.

Comparative Claims Disclaimer: Comparisons between probiotic GLP-1 supplements and prescription GLP-1 medications are provided for informational context only and should not be interpreted as claims that supplements provide equivalent efficacy. Prescription medications have undergone extensive clinical trials demonstrating significant weight loss in controlled conditions. Dietary supplements have not undergone comparable testing. Pricing comparisons reflect typical out-of-pocket costs and illustrative examples; actual costs vary by location, insurance coverage, and individual circumstances.

Industry Analysis Published: December 22, 2025

Content Category: Dietary Supplements – Weight Management

Regulatory Framework: DSHEA supplement regulations, FTC endorsement guidelines, FDA dietary supplement guidance

Target Market: New Year 2026 Weight Loss Season

CONTACT: Phone Support: +1-866-637-2482

Novo Nordisk A/S: Wegovy® pill approved in the US as first oral GLP-1 for weight management

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Novo Nordisk A/S: Wegovy® pill approved in the US as first oral GLP-1 for weight management

Novo Nordisk A/S: Wegovy® pill approved in the US as first oral GLP-1 for weight management

Wegovy^® pill showed a mean weight loss of 16.6% in the OASIS 4 trial¹
Wegovy^® pill is indicated to reduce excess body weight and maintain weight reduction long-term and to reduce the risk of major adverse cardiovascular events*
Novo Nordisk expects to launch Wegovy^® pill in the US in early January 2026

Bagsværd, Denmark, 22 December 2025 – Novo Nordisk today announced that the US Food and Drug Administration (FDA) has approved the Wegovy^® pill (once-daily oral semaglutide 25 mg) to reduce excess body weight and maintain weight reduction long term and to reduce the risk of major adverse cardiovascular events*.

The Wegovy^® pill is the first oral glucagon-like peptide-1 (GLP-1) receptor agonist therapy approved for weight management. The approval is based on the OASIS trial programme and the SELECT trial². In the OASIS 4 trial, oral semaglutide 25 mg taken once daily demonstrated 16.6% mean weight loss when treatment was adhered to in adult participants with obesity or overweight with one or more comorbidities¹. The weight loss achieved with the Wegovy^® pill is similar to that of injectable Wegovy^® 2.4 mg. Furthermore, one in three people experienced 20% or greater weight loss in the OASIS 4 trial¹. The well-known safety and tolerability profile of semaglutide was reaffirmed with the Wegovy^® pill in the OASIS-4 trial, which was comparable to previous trials with semaglutide for weight management.

“The pill is here. With today’s approval of the Wegovy^® pill, patients will have a convenient, once-daily pill that can help them lose as much weight as the original Wegovy^® injection,” said Mike Doustdar, president and CEO of Novo Nordisk. “As the first oral GLP-1 treatment for people living with overweight or obesity, the Wegovy^® pill provides patients with a new, convenient treatment option that can help patients start or continue their weight loss journey. No other current oral GLP-1 treatment can match the weight loss delivered by the Wegovy^® pill, and we are very excited for what this will mean for patients in the US”.

Novo Nordisk expects to launch the Wegovy^® pill in the US in early January 2026. Novo Nordisk has submitted oral semaglutide 25 mg once-daily for obesity to the European Medicines Agency (EMA) and other regulatory authorities during the second half of 2025.

About the OASIS trial programme
OASIS was a phase 3 clinical development programme with once-daily oral semaglutide 25 mg and 50 mg in obesity. The global clinical phase 3 programme consisted of four trials, enrolling approximately 1,300 adults with obesity or overweight with one or more comorbidities.
OASIS 4 was a 64-week efficacy and safety phase 3b trial of once-daily oral semaglutide 25 mg versus placebo in 307 adults with obesity or overweight with one or more comorbidities.

About Wegovy^®
Wegovy^® is now approved as once-daily Wegovy^® pill (semaglutide tablet 25 mg) and once-weekly Wegovy^® injection (semaglutide injectable 2.4 mg) by the FDA. The approval of Wegovy^® pill is based on a New Drug Application to reduce excess body weight in adults with obesity or overweight with at least one weight-related medical condition.

Wegovy^® is approved as a once-weekly injection by the EMA and widely by other regulatory authorities. The Wegovy^® pill is currently pending marketing approval from the EMA and other regulatory authorities.

Wegovy^® is indicated to reduce excess body weight and maintain weight reduction long term in adults with obesity or overweight and in the presence of at least one weight-related comorbid condition, and approved by the FDA to reduce the risk of major adverse cardiovascular events, such as death, heart attack or stroke in adults with known heart disease and either obesity or overweight. Furthermore, Wegovy^® injection is indicated to reduce excess body weight and maintain weight reduction long term in paediatric patients aged 12 years and older, and approved by the FDA for the treatment of MASH in adults with moderate to advanced liver scarring (fibrosis), but not with cirrhosis of the liver.

About Novo Nordisk
Novo Nordisk is a leading global healthcare company founded in 1923 and headquartered in Denmark. Our purpose is to drive change to defeat serious chronic diseases built upon our heritage in diabetes. We do so by pioneering scientific breakthroughs, expanding access to our medicines and working to prevent and ultimately cure disease. Novo Nordisk employs about 78,500 people in 80 countries and markets its products in around 170 countries. Novo Nordisk’s B shares are listed on Nasdaq Copenhagen (Novo-B). Its ADRs are listed on the New York Stock Exchange (NVO). For more information, visit novonordisk.com, Facebook, Instagram, X, LinkedIn and YouTube.

Contacts for further information

Media:
Ambre James-Brown +45 3079 9289 globalmedia@novonordisk.com	Liz Skrbkova (US) +1 609 917 0632 lzsk@novonordisk.com
Investors:
Jacob Martin Wiborg Rode +45 3075 5956 jrde@novonordisk.com	Sina Meyer +45 3079 6656 azey@novonordisk.com
Max Ung +45 3077 6414 mxun@novonordisk.com	Christoffer Sho Togo Tullin +45 3079 1471 cftu@novonordisk.com
Alex Bruce +45 34 44 26 13 axeu@novonordisk.com	Frederik Taylor Pitter +1 609 613 0568 fptr@novonordisk.com

Company announcement No 39 / 2025

*CV death, non-fatal myocardial infarction, or non-fatal stroke
¹Based on the trial product estimand: treatment effect if all people adhered to treatment
²Supported with data from the STEP trial programme and the PIONEER PLUS trial

Attachment

CA251222-Oral-sema-FDA-approval

RxSight, Inc. Announces Chief Financial Officer Transition

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RxSight, Inc. Announces Chief Financial Officer Transition

RxSight, Inc. Announces Chief Financial Officer Transition

ALISO VIEJO, Calif., Dec. 22, 2025 (GLOBE NEWSWIRE) — RxSight, Inc., an ophthalmic medical device company dedicated to providing high-quality customized vision to patients following cataract surgery, today announced that Shelley Thunen, the Company’s Chief Financial Officer, is transitioning from her role. Ms. Thunen will remain with the Company until the sooner of the appointment of her successor or January 31, 2026. Ms. Thunen has agreed to support the Company as a consultant subsequent to the transition.

“Shelley has been a key and trusted partner throughout some of the most important years in RxSight’s development,” said Ron Kurtz, Chief Executive Officer and President of RxSight. “Shelley developed and executed on our financial strategy, and over nearly a decade, her leadership and unwavering commitment helped guide RxSight from a pre-commerical company to one with more than 1,100 LDDs in the field and over a quarter million procedures performed. She has shaped the foundation we rely on today, and we are truly grateful for everything she has done for our patients, our customers, and everyone at RxSight.”

“Shelley has had a profound impact on RxSight,” said Andy Corley, Chairman of the Board. “Her judgment, integrity, and dedication helped guide the Company through pivotal events, including our initial public offering in 2021, and positioned RxSight for the opportunities ahead. The Board is sincerely appreciative of her service and the lasting mark she leaves on the organization.”

About RxSight, Inc.

RxSight, Inc. is an ophthalmic medical device company dedicated to providing high-quality customized vision to patients following cataract surgery. The RxSight^® Light Adjustable Lens system, comprised of the RxSight Light Adjustable Lens^® (LAL^®/LAL+^®, collectively the “LAL”), RxSight Light Delivery Device (LDD™) and accessories, is the first and only commercially available intraocular lens (IOL) technology that can be adjusted after surgery, enabling doctors to customize and deliver high-quality vision to patients after cataract surgery. Additional information about RxSight can be found at www.rxsight.com.

Company Contact:
Shelley B. Thunen
Chief Financial Officer
sthunen@rxsight.com

Investor Relations Contact:
Oliver Moravcevic
VP, Investor Relations
omoravcevic@rxsight.com

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