Idorsia’s daridorexant in women during menopausal transition age with insomnia

Idorsia’s daridorexant in women during menopausal transition age with insomnia




Idorsia’s daridorexant in women during menopausal transition age with insomnia

  • New analysis of a Phase 3 study of daridorexant shows that 50 mg improved both sleep and daytime functioning compared to placebo in women during menopausal transition age
  • Brigham and Women’s Hospital to study the effectiveness and safety of daridorexant for menopause-related insomnia symptoms

Allschwil, Switzerland – January 5, 2026
Idorsia Ltd (SIX: IDIA) announces the publication of “Efficacy and safety of daridorexant for the treatment of insomnia disorder in women during menopausal transition age: Insights from a randomized controlled trial” in Maturitas, a prestigious international journal of midlife health and beyond. This new analysis of the efficacy and safety of daridorexant in women aged 47–55 years with insomnia disorder – a population representative of the menopausal transition – is based on data from the Phase 3 randomized controlled trial (NCT03545191) published in Lancet Neurology and provides important insights into the management of insomnia during in midlife women.

One of the most prevalent and burdensome yet under-researched symptoms reported by women in the menopausal transition is sleep disturbance1,2. Multiple factors, including hormonal changes, vasomotor symptoms (e.g. hot flushes, night sweats), psychological changes (e.g. mood symptoms, depression), development of other sleep disorders (e.g. restless legs syndrome, obstructive sleep apnea), and social demands (e.g. caregiving), may contribute, either triggering the onset of or exacerbating preexisting sleep disturbances3. Sleep disturbances can have a significant impact on physical and mental health, quality of life, and productivity4.

Key findings
Daridorexant 50 mg improved both sleep and daytime functioning compared to placebo.
Change from baseline at Month 3:

  • Wake after sleep onset (WASO) was improved by ~43 minutes.
  • Latency to persistent sleep (LPS) was improved by ~34 minutes.
  • Self-reported total sleep time was improved by ~75 minutes.
  • Daytime functioning and sleep quality scores were improved.

Furthermore, the incidence of somnolence and fatigue was low and comparable to placebo, and no increase in next-morning sleepiness was observed compared to placebo.

Dr Zoe Schaedel, BMedSci, BMBS, MRCGP, DRCOG, DFSRH, PGCertMedEd, General Practitioner, British Menopause Society (BMS) Menopause Specialist and co-author of the manuscript, commented: “Insomnia disorder affects approximately one in four women during the menopausal transition, yet is often underdiagnosed and certainly undertreated. This analysis shows that daridorexant 50 mg offered meaningful improvements in sleep and daytime functioning without compromising safety. It is essential that clinicians consider the diagnosis of insomnia disorder when sleep disturbances arise during the menopause transition rather than considering it merely secondary to menopausal symptoms, allowing access to evidence-based treatments.”

New Brigham and Women’s Hospital study
Principal investigators, Dr Bertisch and Dr Redline, from the Brigham and Women’s Hospital, a teaching affiliate of Harvard Medical School, have selected daridorexant, Idorsia’s dual orexin receptor antagonist (DORA), to be included in a study, CELESTE, focused on menopause-related insomnia. The study will compare the effectiveness and safety of different approaches to treat menopause-related insomnia, including daridorexant as the only pharmacotherapy approved for the treatment of insomnia. Results will help clinicians and their patients when considering ways to treat menopause-related insomnia.

Delivering on the company’s commitment to advance the science of sleep and insomnia, Idorsia will be providing daridorexant at no cost, to support this ground-breaking study.

Antonio Olivieri, MD, Chief Medical Officer & Head of Global Medical Affairs at Idorsia commented: “We are excited for daridorexant to be included in this important study, as insomnia is associated with numerous serious health conditions, and is particularly common in women dealing with menopause. Daridorexant works differently from other insomnia medications by decreasing overactive wake signaling, which is a key cause of insomnia. We look forward to seeing the results and continuing to advance the science of insomnia.”

About the CELESTE study NCT07136415
Funded by the Patient-Centered Outcomes Research Institute (PCORI), the CELESTE study will include around 900 peri- and post-menopausal women with insomnia. Participants will receive treatment for 12 months and insomnia symptoms will be measured using surveys at the start of the study and again three, six and 12 months later. Treatments, including daridorexant, which is approved by the FDA for adults with insomnia, will be monitored to see if they work differently based on factors such the severity of hot flashes, presence of sleep apnea, and menopause stage. The study will be randomized with daridorexant being one of the three-arm study and is expected to be conducted over a 60-month period.

Global availability of daridorexant
Daridorexant is marketed as QUVIVIQ™ by Idorsia in the US, Canada, and multiple European countries, and is available in Japan, Hong Kong, and China through strategic partnerships.

The daridorexant Phase 3 registration program5
The global registration program demonstrated that 25mg and 50mg doses of daridorexant significantly improved sleep onset, sleep maintenance and self-reported total sleep time at months 1 and 3 compared to placebo. A major focus of the trials was to evaluate the impact of daridorexant on daytime functioning in patients with insomnia, as assessed by the IDSIQ. The sleepiness domain score of the IDSIQ was evaluated as a key secondary endpoint in both pivotal studies, and comparisons to placebo included control for multiplicity. Daridorexant 50 mg demonstrated a highly significant improvement in daytime functioning, as measured by the sleepiness domain at month 1 and month 3.

For the US:
Important Safety Information

Do not take QUVIVIQ if you fall asleep often at unexpected times (narcolepsy) or if you are allergic to QUVIVIQ or any of its ingredients.

QUVIVIQ may cause serious side effects, including:

  • Decreased awareness and alertness. The morning after you take QUVIVIQ, your ability to drive safely and think clearly may be decreased. You may also have sleepiness during the day. Sleepiness may increase your risk of falls.
    • Do not take more QUVIVIQ than prescribed.
    • Do not take QUVIVIQ unless you are able to stay in bed for at least 7 hours before you must be active again.
    • Take QUVIVIQ at night within 30 minutes before going to bed.

QUVIVIQ is a federally controlled substance because it can be abused or lead to dependence.

Before taking QUVIVIQ, tell your healthcare provider about all of your medical conditions, including if you:

  • have a history of depression, mental illness, or suicidal thoughts or actions; drug or alcohol abuse or addiction; a sudden onset of muscle weakness (cataplexy); daytime sleepiness
  • have lung or breathing problems, including sleep apnea
  • have liver problems
  • are pregnant or plan to become pregnant
  • are breastfeeding or plan to breastfeed

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

  • Taking QUVIVIQ with certain medicines can cause serious side effects. QUVIVIQ may affect the way other medicines work and other medicines may affect the way QUVIVIQ works.
  • Do not take QUVIVIQ with other medicines that can make you sleepy unless instructed by your healthcare provider.

What should I avoid while taking QUVIVIQ?

  • Do not drink alcohol while taking QUVIVIQ. It can increase the effects of alcohol, which can be dangerous.  
  • Do not drive, operate heavy machinery, do anything dangerous, or do other activities that require clear thinking if you do not feel fully awake, or you have taken QUVIVIQ and have less than a full night of sleep (at least 7 hours), or if you have taken more QUVIVIQ than prescribed.

QUVIVIQ may cause other serious side effects, including:

  • Worsening depression and suicidal thoughts. Call your healthcare provider right away if you have any worsening depression or thoughts of suicide or dying.
  • Temporary inability to move or talk (sleep paralysis) for up to several minutes, or hallucinations while you are going to sleep or waking up.
  • Temporary weakness in your legs that can happen during the day or at night
  • Complex sleep behaviors such as sleepwalking, sleep-driving, preparing and eating food, making phone calls, having sex or doing other activities while not fully awake that you may not remember the next morning. Stop taking QUVIVIQ and call your healthcare provider right away if you experience a complex sleep behavior.

The most common side effects of QUVIVIQ are headache and sleepiness or tiredness.

These are not the only side effects of QUVIVIQ. Call your doctor for 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

Notes to the editor

About insomnia
Insomnia is defined as a combination of dissatisfaction with sleep and a significant negative impact on daytime functioning. Dissatisfaction with sleep refers to the difficulty to initiate and/or maintain sleep on at least three nights per week for at least three months, despite adequate opportunity to sleep.

Insomnia is a condition of overactive wake signaling and studies have shown that areas of the brain associated with wakefulness remain more active during sleep in patients with insomnia.

Insomnia as a disorder is quite different from a brief period of poor sleep, and it can take its toll on both physical and mental health. It is a persistent condition with a negative impact on daytime functioning. Idorsia’s research has shown that poor-quality sleep can affect many aspects of daily life, including the ability to concentrate, mood, and energy levels.

The goals of managing insomnia are to improve sleep quality and quantity, as well as daytime functioning. Current recommended treatment of insomnia includes sleep hygiene recommendations, cognitive behavioral therapy and pharmacotherapy.

About Dr Zoe Schaedel
Dr Zoe Schaedel, of Myla Health, is an experienced Menopause Specialist. She specialises in women’s health, menopause care, sexual health and contraception. She is an accredited specialist with the British Menopause Society (BMS) and is a member of the BMS Medical Advisory Council.

Dr Schaedel contributes to a number of national committees including the NHS England Menopause Improvement Programme and she has delivered talks and masterclasses nationally and to organisations on menopause and on the interplay between menopause, mental health and sleep. She has published articles on menopause in The Lancet and Post Reproductive Health. Dr Schaedel is a trainer for the British Menopause Society and loves to support clinicians who want to further their knowledge on women’s health. Dr Schaedel serves as a consultant to Idorsia.

References

  1. El Khoudary SR, Greendale G, Crawford SL, et al. The menopause transition and women’s health at midlife: a progress report from the Study of Women’s Health Across the Nation (SWAN). Menopause. Oct 2019;26(10):1213-1227. doi:10.1097/gme.0000000000001424
  2. Schaedel Z, Holloway D, Bruce D, Rymer J. Management of sleep disorders in the menopausal transition. Post Reproductive Health. 2021;27(4):209-214. doi:10.1177/20533691211039151
  3. Tobias L, Thapa S, Won CHJ. Impact of Sex on Sleep Disorders Across the Lifespan. Clinics in Chest Medicine. 2021/09/01/ 2021;42(3):427-442. doi:https://doi.org/10.1016/j.ccm.2021.04.005
  4. Bolge SC, Joish VN, Balkrishnan R, Kannan H, Drake CL. Burden of chronic sleep maintenance insomnia characterized by nighttime awakenings. Popul Health Manag. Feb 2010;13(1):15-20. doi:10.1089/pop.2009.0028
  5. Mignot E, Mayleben D, Fietze I, et al. Safety and efficacy of daridorexant in patients with insomnia disorder: results from two multicentre, randomised, double-blind, placebo-controlled, phase 3 trials. Lancet Neurol. 2022 Feb;21(2):125-139. doi: 10.1016/S1474-4422(21)00436-1.

About Idorsia
The purpose of Idorsia is to challenge accepted medical paradigms, answering the questions that matter most. To achieve this, we will discover, develop, and commercialize transformative medicines – either with in-house capabilities or together with partners – and evolve Idorsia into a leading biopharmaceutical company, with a strong scientific core.

Headquartered near Basel, Switzerland – a European biotech hub – Idorsia has a highly experienced team of dedicated professionals, covering all disciplines from bench to bedside; QUVIVIQ™ (daridorexant), a different kind of insomnia treatment with the potential to revolutionize this mounting public health concern; strong partners to maximize the value of our portfolio; a promising in-house development pipeline; and a specialized drug discovery engine focused on small-molecule drugs that can change the treatment paradigm for many patients. Idorsia is listed on the SIX Swiss Exchange (ticker symbol: IDIA).

For further information, please contact:
Investor & Media Relations
Idorsia Pharmaceuticals Ltd, Hegenheimermattweg 91, CH-4123 Allschwil
+41 58 844 10 10
investor.relations@idorsia.com – media.relations@idorsia.com – www.idorsia.com

The above information contains certain “forward-looking statements”, relating to the company’s business, which can be identified by the use of forward-looking terminology such as “intend”, “estimates”, “believes”, “expects”, “may”, “are expected to”, “will”, “will continue”, “should”, “would be”, “seeks”, “pending” or “anticipates” or similar expressions, or by discussions of strategy, plans or intentions. Such statements include descriptions of the company’s investment and research and development programs, business development activities and anticipated expenditures in connection therewith, descriptions of new products expected to be introduced by the company and anticipated customer demand for such products and products in the company’s existing portfolio. Such statements reflect the current views of the company with respect to future events and are subject to certain risks, uncertainties and assumptions. Many factors could cause the actual results, performance or achievements of the company to be materially different from any future results, performances or achievements that may be expressed or implied by such forward-looking statements. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those described herein as anticipated, believed, estimated or expected.

Attachment

Zealand Pharma to present at the J.P. Morgan Healthcare Conference

Zealand Pharma to present at the J.P. Morgan Healthcare Conference




Zealand Pharma to present at the J.P. Morgan Healthcare Conference

Press release – No. 1 / 2026

Zealand Pharma to present at the J.P. Morgan Healthcare Conference

Copenhagen, Denmark, January 5, 2026 – Zealand Pharma A/S (“the Company” or “Zealand Pharma”) (Nasdaq: ZEAL) (CVR-no. 20045078), a biotechnology company transforming the future of metabolic health, today announced that the Company will participate in the 44th J.P. Morgan Healthcare Conference on January 12-15, 2026 in San Francisco, California.

Adam Steensberg, President and Chief Executive Officer, will take part in a presentation and fireside chat on Wednesday January 14 at 1:30pm PST / 10:30pm CET. A live audio webcast will be available at: https://jpmorgan.metameetings.net/events/healthcare26/sessions/317741-zealand-pharma/webcast?gpu_only=true&kiosk=true.
A replay of the webcast will be available at https://www.zealandpharma.com/events/.

About Zealand Pharma A/S
Zealand Pharma A/S (Nasdaq: ZEAL) is a biotechnology company focused on advancing medicines for obesity and metabolic health. Combining more than 25 years of peptide R&D expertise with a proprietary data platform that leverages advanced data‑driven and AI/ML approaches, Zealand Pharma aims to lead a new era in obesity and metabolic health.

To date, more than ten Zealand Pharma‑invented drug candidates have entered clinical development, of which two products have reached the market and three candidates are in late-stage development. The Company has collaborations with global pharmaceutical and biotechnology partners for research, development, and commercialization.

Founded in 1998, Zealand Pharma is headquartered in Copenhagen, Denmark, with a U.S. presence in Boston, Massachusetts. Learn more at www.zealandpharma.com.  

Contacts
Adam Lange (Investors)
Vice President, Investor Relations
Zealand Pharma
Email: alange@zealandpharma.com

Neshat Ahmadi (Investors)
Investor Relations Manager
Zealand Pharma
Email: neahmadi@zealandpharma.com

Rachel James-Owens (Media)
Vice President, Corporate Communications & Media Relations
Zealand Pharma
RJamesOwens@zealandpharma.com

Amber Fennell, Jessica Hodgson, Sean Leous (Media)
ICR Healthcare
ZealandPharma@icrhealthcare.com
+44 (0) 7739 658 783

DentPrime Publishes Comprehensive Patient Guidance Framework for Individuals Considering Dental Treatment Abroad

DentPrime Publishes Comprehensive Patient Guidance Framework for Individuals Considering Dental Treatment Abroad




DentPrime Publishes Comprehensive Patient Guidance Framework for Individuals Considering Dental Treatment Abroad

Exterior view of DentPrime dental clinic in Antalya, Turkey
Photo: DentPrime via FL Comms.

ANTALYA, Türkiye, Jan. 05, 2026 (GLOBE NEWSWIRE) — DentPrime today announced the publication of a comprehensive patient guidance framework designed to support individuals who are considering dental treatment abroad. The framework aims to provide structured, clinically grounded information to help patients better understand how to evaluate dental clinics, treatment plans and long-term care considerations before committing to overseas treatment.

The initiative responds to growing international interest in cross-border dental care, particularly among patients researching complex procedures such as dental implants in Turkey and restorative treatments that require careful planning and specialist involvement. DentPrime noted that while access to information has increased, patients are often required to make decisions based on fragmented or commercially focused content that does not fully explain clinical standards, risks or aftercare responsibilities.

“Dental treatment is not a commodity that can be assessed on price or appearance alone,” said a DentPrime spokesperson. “Patients need clear, medically sound information that explains not only what a treatment involves, but how it should be planned, delivered and supported over time. This framework was developed to help patients ask the right questions before making decisions.”

Focus on Clinical Experience and Specialist Care

A central element of the DentPrime framework highlights the importance of clinical experience and specialist qualifications. The guidance explains that while accessibility and communication are important, successful outcomes depend heavily on practitioner expertise, particularly in surgical and multi-stage treatments.

DentPrime advises patients to understand who will deliver their treatment, what their clinical background is and whether they have specific experience relevant to the proposed procedures. This is especially critical for implant-based care and extensive restorative treatments.

Consultation, Diagnostics and Informed Consent

The framework places strong emphasis on comprehensive consultation and diagnostic assessment as prerequisites for safe dental care. DentPrime notes that treatment plans developed without reviewing recent radiographs, three-dimensional dental imaging or a patient’s full medical history may lead to inaccurate diagnoses and unexpected complications.

According to the guidance, patients should expect a structured consultation process that includes advanced imaging, detailed oral examination and clear explanations of treatment options. Informed consent is identified as a critical step, requiring that patients fully understand potential risks, alternative approaches, healing timelines and financial considerations before treatment begins.

Material Quality and Laboratory Standards

Another key focus of the DentPrime guidance relates to material quality and laboratory standards used in restorative dentistry. The framework explains that long-term outcomes depend not only on clinical skill, but also on the quality and compatibility of materials used in implants, crowns and restorations.

Interior of a dental treatment room at DentPrime clinic in Antalya, Turkey

Photo: DentPrime via FL Comms.

Discussions around zirconium crowns in Turkey, for example, often highlight the importance of material sourcing, digital design workflows and laboratory precision in achieving durable and natural-looking results. DentPrime encourages patients to seek transparency regarding the materials used and the standards applied during fabrication.

Pricing Logic and Treatment Planning

While cost differences between countries may influence patient decisions, DentPrime’s framework cautions against evaluating dental care solely on price. The guidance explains that extremely low fees may indicate compromises in diagnostics, materials, laboratory processes or follow-up care.

DentPrime patient in Istanbul representing international dental treatment experience in Turkey
Photo: DentPrime via FL Comms.

Patients are encouraged to assess whether treatment proposals include realistic timelines, appropriate healing periods and comprehensive planning rather than focusing exclusively on headline pricing.

Aftercare and Long-Term Outcomes

The DentPrime framework places particular importance on aftercare and long-term treatment outcomes. Dental treatments, especially implant-based and restorative procedures, require ongoing maintenance, monitoring and patient compliance to ensure lasting success.

DentPrime advises patients to understand what follow-up care is provided, how complications are addressed and what guarantees apply to different components of their treatment. The guidance emphasises that long-term success depends on a combination of clinical execution, material quality and patient adherence to recommended care protocols.

Supporting Informed Decision-Making

DentPrime stated that the publication of the guidance framework reflects its broader commitment to patient education and evidence-based care. By consolidating clinical principles into a single, accessible resource, the organisation aims to support patients in making informed decisions that prioritise safety, transparency and long-term oral health.

As interest in dental treatment abroad continues to grow, informed decision-making becomes increasingly important,” the DentPrime spokesperson added. “This framework is designed to help patients understand what high-quality dental care should look like, regardless of where it is delivered.”

About DentPrime

DentPrime is a dental clinic based in Antalya, Türkiye, providing dental healthcare services to international patients. The clinic aims to combine modern dental practices with structured treatment planning, comprehensive diagnostic processes, and a strong focus on patient information and communication.

DentPrime places particular emphasis on treatment pathways designed for patients travelling from abroad, prioritising detailed consultations, advanced imaging techniques, and personalised treatment plans. The clinic offers a range of services, including dental implant treatments, restorative dentistry procedures, and aesthetic dental care.

Contact:
Furkan Luleci
furkan@flcommunications.co.uk 

Photos accompanying this announcement are available at

https://www.globenewswire.com/NewsRoom/AttachmentNg/7ace0173-084e-4a38-aa21-fb1a124b01db

https://www.globenewswire.com/NewsRoom/AttachmentNg/ffc63df7-3fba-452c-ad30-61b7b0501c1f

https://www.globenewswire.com/NewsRoom/AttachmentNg/77eb72c3-25a3-4159-ab2c-d419274c78ac

A Better Life Therapy Joins the Lumina Therapy Alliance, Marking a Major Expansion of the Nation’s Gold Standard for Concierge, In-Person Mental Health Care

A Better Life Therapy Joins the Lumina Therapy Alliance, Marking a Major Expansion of the Nation’s Gold Standard for Concierge, In-Person Mental Health Care




A Better Life Therapy Joins the Lumina Therapy Alliance, Marking a Major Expansion of the Nation’s Gold Standard for Concierge, In-Person Mental Health Care

Elizabeth Earnshaw’s nationally recognized Philadelphia practice brings elite clinical leadership, cultural influence, and high-touch care to Lumina’s growing employer-focused network

NEW YORK, Jan. 05, 2026 (GLOBE NEWSWIRE) — Lumina Therapy Alliance, the nation’s premier collective of highly vetted, in-person mental health practices, today announced that A Better Life Therapy, the acclaimed Philadelphia-based practice founded and led by Elizabeth Earnshaw, LMFT, has officially joined its expanding national alliance.

This addition represents a defining moment for Lumina. A Better Life Therapy is widely regarded as a gold standard practice—known for its clinical sophistication, elevated client experience, and cultural impact well beyond its physical footprint. Led by Earnshaw, one of the most influential voices in modern therapy, the practice exemplifies the future of premium, relationship-based mental health care.

Elizabeth Earnshaw’s platform, @lizlistens, reaches a massive nationwide audience, shaping how millions understand relationships, attachment, trauma, and emotional health. Her work bridges deep clinical rigor with cultural relevance—bringing credibility, trust, and visibility that few practices in the country can match.

“A Better Life Therapy represents everything Lumina stands for,” said Dr. Daniel Selling, Founder of Lumina Therapy Alliance. “This is a practice that has earned national influence without compromising depth, integrity, or the in-person therapeutic experience. Elizabeth and her team have built something rare—beautiful brick-and-mortar spaces, extraordinary clinicians, and a level of care that truly changes lives. Their decision to join Lumina is a powerful signal of where high-end mental health care is headed.”

A Model Built for Today’s Employers

A Better Life Therapy’s entry into the Alliance significantly strengthens Lumina’s offering to employers seeking meaningful alternatives to underutilized teletherapy and EAP platforms. With a strong emphasis on high-touch concierge therapy, relational depth, and thoughtfully designed physical spaces, the practice delivers what today’s professionals increasingly demand: discretion, consistency, and real human connection.

For employers, this means access to a trusted, culturally respected practice that resonates with modern workforces—particularly leaders, creatives, and high-performing professionals navigating stress, relationships, trauma, and burnout.

“Joining Lumina felt like a natural alignment,” said Elizabeth Earnshaw, LMFT, Founder of A Better Life Therapy. “We believe deeply in the power of in-person work, intentional spaces, and care that meets people with nuance and humanity. Lumina is building something truly special—an alliance that honors clinical excellence while expanding access for individuals, families, and workplaces that want more than surface-level support.”

Raising the National Bar

Lumina Therapy Alliance was founded to curate the country’s most respected independent therapy practices into a single national standard—without sacrificing autonomy, culture, or quality. The Lumina Therapy Alliance now has over 250 clinicians! A Better Life Therapy joins a growing roster of elite practices that are redefining what premium mental health care looks like in the employer and concierge space.

This partnership reinforces Lumina’s mission: to offer employers and their teams real care, in real spaces, from real experts—and to move the industry beyond transactional, low-engagement mental health solutions.

About A Better Life Therapy

A Better Life Therapy is a Philadelphia-based psychotherapy practice known for its sophisticated, relationship-centered approach to mental health care. Founded by Elizabeth Earnshaw, LMFT, the practice specializes in attachment-based therapy, trauma-informed care, and relational healing for individuals, couples, and families. With beautifully designed in-person locations and a team of highly trained clinicians, A Better Life Therapy delivers an elevated, deeply human therapeutic experience rooted in clinical excellence and emotional depth. Elizabeth Earnshaw is also the creator of the nationally influential platform @lizlistens, which reaches millions and has helped reshape the public conversation around relationships and mental health.

About Lumina Therapy Alliance

Lumina Therapy Alliance is the nation’s leading collective of highly vetted, premium, in-person mental health practices built to serve modern employers and their workforces. Lumina partners with elite brick-and-mortar therapy groups across the country to deliver high-touch concierge mental health care—offering a powerful alternative to underutilized teletherapy and traditional EAP models. By uniting the best independent practices under a shared standard of excellence, Lumina is redefining how employers support mental health: with depth, discretion, and real clinical impact.

For more information contact us:

contact@luminatherapyalliance.com

Mainz Biomed Provides Review of 2025 Highlights

Issuer: Mainz BioMed N.V.

/ Key word(s): Miscellaneous

Mainz Biomed Provides Review of 2025 Highlights

05.01.2026 / 14:15 CET/CEST

The issuer is solely responsible for the content of this announcement.


Mainz Biomed Provides Review of 2025 Highlights

Initiation of eAArly DETECT 2 – U.S. Clinical Study to Evaluate Performance of Next Generation Test on Advanced Adenomas over Large Patient Population in Preparation for ReconAAsense U.S. FDA Pivotal Trial

Results from Feasibility Study of Biomarker Panel in Pancreatic Cancer Project Study Demonstrated a Sensitivity of 100% and Specificity of 95%

BERKELEY, US – MAINZ, Germany – January 5, 2026 — Mainz Biomed N.V. (NASDAQ:MYNZ) (“Mainz Biomed” or the “Company”), a molecular genetics diagnostic company specializing in the early detection of cancer, today reviewed its major accomplishments for the year ended December 31, 2025. The Company expects to release its year-end financial results in March 2026.

Key Highlights During 2025

Colorectal Cancer Business Highlights

  • Mainz Biomed launched eAArly DETECT 2, a US feasibility study to evaluate the Company’s next generation colorectal cancer (CRC) test, integrating its proprietary mRNA biomarkers, AI developed algorithm and FIT test, over a population of approximately 2,000 patients, all of average risk, to validate the leading results of previous feasibility studies, which included average risk and identified risk patients.
  • ColoAlert®, the Company’s DNA-based colorectal cancer (CRC) screening test, received official registration with the Medicines and Healthcare products Regulatory Agency (MHRA) and is now authorized for marketing in the United Kingdom.
  • ColoAlert® has also been officially registered and approved for distribution by Swissmedic, the Swiss regulatory and supervisory authority for medicinal products and medical devices.
  • The Company entered into a strategic partnership with labor team w ag, a renowned diagnostic laboratory based in Goldach, Switzerland. This collaboration introduces ColoAlert®, a DNA-based colorectal cancer screening test to the Swiss market for the very first time, marking Mainz Biomed’s initial footprint in Switzerland.
  • Mainz Biomed signed a Memorandum of Understanding (“MOU”) with OncoVanguard8, a distributor of oncological innovations. The collaboration aims to introduce ColoAlert® to South America, starting with Peru.
  • Mainz Biomed collaborated with CARE diagnostica Laborreagenzien GmbH (“CARE”). CARE is currently working with more than 15 statutory health insurance companies as part of special online-based screening concepts based on the widely used fecal immunochemical test (FIT). Thanks to the cooperation with Mainz Biomed, the range of services for risk groups could potentially be expanded to include the ColoAlert® test, which uses molecular genetic analysis of biomarkers in stool using PCR to increase the detection rate, particularly in the early stages of the disease.
  • Mainz Biomed also announced that ColoAlert® has been added to the portfolio of DoctorBox, one of Germany’s leading pioneers in digital health. This marks another important milestone in Mainz Biomed’s European growth strategy and highlights the increasing importance of innovative, personalized solutions in preventive medicine. Laboratory analysis will be performed by Mainz Biomed’s long-standing partner, the European Oncology Lab, led by Dr. med. Annette Buhlmann in St. Ingbert, Germany.

Pancreatic Cancer Business Highlights

  • In March 2025 the Company entered into a License and Option Agreement with Liquid Biosciences (“Liquid”) to access a portfolio of novel mRNA biomarkers for the non-invasive detection of pancreatic cancer with a blood test. The parties, under the Agreement, plan to develop this blood-based test for potential future FDA applications. The discovery process included multiple independent pancreatic cancer study cohorts. Liquid used their proprietary EMERGE platform to identify a panel of clinically relevant mRNA biomarkers from a blood-based cohort of 285 subjects with 35 pancreatic cancer patients. In the analysis, the biomarkers coupled with the proprietary algorithm developed by Liquid achieved overall sensitivity of 95% and a 98% specificity for the detection of pancreatic cancer. If the statistical results are replicable after the integration into a new product, it has the potential to ultimately position Mainz Biomed’s test to be the most robust and accurate screening test for pancreatic cancer on the market.
  • In October 2025 the Company announced positive topline results from its feasibility study, examining a non-invasive blood-based screening test for the early detection of pancreatic cancer, initiated earlier in 2025. The study confirmed the strong clinical accuracy and utility of licensed proprietary biomarkers from Liquid Biosciences for developing an innovative screening test for pancreatic cancer. Researchers evaluated 18 licensed biomarkers across multiple candidate panels to streamline assay complexity. The leading panel achieved 100% sensitivity and 95% specificity, successfully distinguishing pancreatic cancer patients from healthy controls in a 30-subject cohort, reflecting different stages of the disease as well as precursors.
  • Mainz Biomed announced that its pancreatic cancer project will receive public funding from the Investitions- und Strukturbank Rheinland-Pfalz (ISB), the development bank of the German federal state of Rheinland-Pfalz. Under the ISB’s Innovation and Technology Support Program (Innovations- und Technologieförderungsprogramm), the state will fund up to 50% of the project’s total costs. This direct governmental support represents a strong endorsement of the scientific and societal value of the Company’s non-invasive, blood-based screening test for the early detection of pancreatic cancer and will accelerate its development.

“I’m extremely pleased with the achievements of our team during 2025 as we advance our ambitious growth strategy, driven by our eAArly DETECT 2 study and continued progress in our pancreatic cancer screening program,” commented Guido Baechler, Chief Executive Officer of Mainz Biomed. “Looking ahead to the first half of 2026, we expect to complete our eAArly DETECT 2 feasibility study, which will be the launching point for our ReconAAsense US FDA pivotal colorectal cancer study in 2026, and to announce our next steps in advancing our blood-based screening test for the early detection of pancreatic cancer.”

Please visit Mainz Biomed’s official website for investors at mainzbiomed.com/investors/ for more information

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About Mainz Biomed NV
Mainz Biomed develops market-ready molecular genetic diagnostic solutions for life-threatening conditions. The Company’s flagship product is ColoAlert®, an accurate, non-invasive and easy-to-use, early-detection diagnostic test for colorectal cancer. ColoAlert® is marketed across Europe. The Company is currently running its eAArly DETECT 2 clinical study in preparation for its pivotal FDA study for US regulatory approval. Mainz Biomed’s product candidate portfolio also includes PancAlert, an early-stage pancreatic cancer screening test based on real-time Polymerase Chain Reaction-based (PCR) multiplex detection of molecular-genetic biomarkers in blood and stool samples. To learn more, visit mainzbiomed.com or follow us on LinkedIn, Twitter and Facebook.

For media inquiries as to Mainz Biomed:

MC Services AG
Maximilian Schur / Simone Neeten
+49 211 529252 20
mainzbiomed@mc-services.eu

For investor inquiries, please contact ir@mainzbiomed.com 

Forward-Looking Statements
Certain statements made in this press release are “forward-looking statements” within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements may be identified by the use of words such as “anticipate”, “believe”, “expect”, “estimate”, “plan”, “outlook”, and “project” and other similar expressions that predict or indicate future events or trends or that are not statements of historical matters. These forward-looking statements reflect the current analysis of existing information and are subject to various risks and uncertainties. As a result, caution must be exercised in relying on forward-looking statements. Due to known and unknown risks, actual results may differ materially from the Company’s expectations or projections. The following factors, among others, could cause actual results to differ materially from those described in these forward-looking statements: (i) the failure to meet projected development and related targets; (ii) changes in applicable laws or regulations; (iii) the effect of the COVID-19 pandemic on the Company and its current or intended markets; and (iv) other risks and uncertainties described herein, as well as those risks and uncertainties discussed from time to time in other reports and other public filings with the Securities and Exchange Commission (the “SEC”) by the Company. Additional information concerning these and other factors that may impact the Company’s expectations and projections can be found in its initial filings with the SEC, including its annual report on Form 20-F filed on March 31, 2025 and its mid-year report on Form 6-K filed on September 26, 2025. The Company’s SEC filings are available publicly on the SEC’s website at www.sec.gov. Any forward-looking statement made by us in this press release is based only on information currently available to Mainz Biomed and speaks only as of the date on which it is made. Mainz Biomed undertakes no obligation to publicly update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise, except as required by law.


Dissemination of a Corporate News, transmitted by EQS News – a service of EQS Group.
The issuer is solely responsible for the content of this announcement.

The EQS Distribution Services include Regulatory Announcements, Financial/Corporate News and Press Releases.


Language: English
Company: Mainz BioMed N.V.
Robert-Koch-Strasse 50
55129 Mainz
Germany
Internet: mainzbiomed.com
EQS News ID: 2254080

 
End of News EQS News Service

Kailera Therapeutics Appoints Doug Pagán as Chief Financial Officer

Kailera Therapeutics Appoints Doug Pagán as Chief Financial Officer




Kailera Therapeutics Appoints Doug Pagán as Chief Financial Officer

Proven financial and strategic leader with over two decades of experience driving organizational growth, operational excellence, and long‑term value creation

WALTHAM, Mass. and SAN DIEGO, Jan. 05, 2026 (GLOBE NEWSWIRE) — Kailera Therapeutics, Inc., an advanced clinical-stage biotechnology company focused on elevating the next era of obesity care, today announced the appointment of Doug Pagán as its Chief Financial Officer.

“Doug brings a proven ability to guide organizations through pivotal inflection points, and his financial and strategic insight will be invaluable as we scale the organization and advance our clinical-stage pipeline, including the KAI-9531 global Phase 3 program,” said Ron Renaud, President and Chief Executive Officer of Kailera. “His leadership will play a key role in supporting growth, execution and long-term value creation, and we’re thrilled to welcome Doug to the Kailera team.”

“I’m excited to join Kailera at this transformative stage as the company progresses its clinical programs with the potential to reshape the future of obesity care,” said Doug Pagán, Chief Financial Officer of Kailera. “I look forward to partnering with the team to align financial strategy with execution as the organization scales and continues to make meaningful progress toward Kailera’s mission to deliver potentially category-leading treatments to people living with obesity.”

Doug brings more than two decades of experience in finance, investor relations, and capital formation across both public and private biopharmaceutical companies. Prior to joining Kailera, he served as Chief Financial Officer and Chief Operating Officer of Atalanta Therapeutics, where he currently serves on the Board of Directors. Before Atalanta, he served as Chief Financial Officer and Chief Operating Officer of Jnana Therapeutics. Prior to Jnana, Doug held Chief Financial Officer roles at Dicerna Pharmaceuticals, KSQ Therapeutics and Paratek Pharmaceuticals. He has previously held leadership roles at Acceleron and Biogen and has served on the Board of Directors of Ziopharm Oncology and Timberlyne Therapeutics. Doug earned his MBA in Finance & Accounting from Columbia Business School and a BSE in Chemical Engineering from Princeton University.

About Kailera Therapeutics
Kailera Therapeutics (Kailera) is an advanced clinical-stage biotechnology company focused on elevating the next era of obesity care by progressing a diversified pipeline to provide options for people living with obesity no matter where they are in their treatment journey. With an obesity-first focus, Kailera is advancing four clinical-stage product candidates leveraging multiple GLP-1-based mechanisms of action and routes of administration specifically designed to address critical needs in the current therapeutic landscape. The lead product candidate, KAI-9531, is advancing to global Phase 3 trials as a once-weekly injectable GLP-1/GIP receptor dual agonist with the potential to offer the greatest weight loss compared to all obesity management medications currently marketed or in development with a tolerability profile that is class-like or better. Kailera is expanding the KAI-9531 franchise by developing a once-daily oral tablet formulation, KAI-9531-T, with the goal of providing a convenient oral option with the potential for highly differentiated tolerability and compelling weight loss. Additionally, Kailera is advancing the development of KAI-7535, a once-daily oral small molecule GLP-1 receptor agonist with the potential to improve upon the clinical profile of existing oral treatments, and KAI-4729, a once-weekly injectable GLP-1/GIP/glucagon receptor tri-agonist, that leverages an incremental mechanism to potentially deliver compelling weight loss, improved liver fat reduction and a differentiated tolerability profile. Kailera’s vision is to deliver category-leading obesity management medications that give people the power to restore their health and transform their lives. Kailera is based in Waltham, MA and San Diego, CA. For more information, visit www.kailera.com and follow us on LinkedIn and X.

Contact Information
Maura Gavaghan
Vice President, Corporate Communications and Investor Relations
maura.gavaghan@kailera.com

LifeMD Expands Collaboration with Novo Nordisk as Recognized Telehealth Partner Offering Newly Approved Wegovy® Pill

LifeMD Expands Collaboration with Novo Nordisk as Recognized Telehealth Partner Offering Newly Approved Wegovy® Pill




LifeMD Expands Collaboration with Novo Nordisk as Recognized Telehealth Partner Offering Newly Approved Wegovy® Pill

Adds first and only FDA‑approved oral GLP‑1 to its virtual weight management offering, expanding access to affordable, branded treatment options

NEW YORK, Jan. 05, 2026 (GLOBE NEWSWIRE) — LifeMD, Inc. (Nasdaq: LFMD), a leading provider of virtual primary care and pharmacy services, today announced it is now offering Novo Nordisk’s Wegovy® (semaglutide) pill – the first and only FDA-approved oral GLP-1 therapy for chronic weight management and cardiovascular health – through its end-to-end telehealth platform. Eligible patients can access the Wegovy® pill for as little as $149 per month, further expanding LifeMD’s portfolio of branded obesity treatments.

This announcement broadens LifeMD’s long-standing collaboration with Novo Nordisk. As part of the relationship, LifeMD is featured on the NovoCare® and Wegovy® websites as a trusted telehealth provider, reflecting growing demand for convenient, clinically supported access to branded GLP-1 therapies.

On December 22, 2025, the U.S. Food and Drug Administration (FDA) approved Novo Nordisk’s Wegovy® pill as the first and only oral GLP-1 therapy indicated to reduce excess body weight, support long-term weight maintenance, and reduce the risk of certain major adverse cardiovascular events.1 FDA approval of the Wegovy® pill was supported by a 64-week Phase 3 trial showing weight loss efficacy unmatched by other oral GLP-1 candidates, with once-daily treatment plus diet and exercise achieving 16.6% mean weight loss versus 2.7% with placebo.2 The availability of an oral formulation is expected to broaden access to GLP‑1 treatment by offering an alternative option for patients who may be hesitant to initiate or continue weekly injections.

“In close collaboration with Novo Nordisk, we moved quickly to bring the Wegovy® pill to patients through LifeMD at the attractive cash-pay price, reinforcing our role as a preferred virtual destination for evidence-based medical weight management,” said Justin Schreiber, Chairman and Chief Executive Officer of LifeMD. “We believe oral GLP-1 therapies represent an important next phase in obesity care. By supporting patients seeking care through Novo’s ‘Find a Doctor’ feature – alongside our own strong patient acquisition capabilities – we see a substantial long-term opportunity to further expand access and deliver a seamless experience that combines comprehensive clinical support with branded GLP-1 therapies shipped directly to patients’ homes.”

LifeMD’s integration with NovoCare® Pharmacy provides streamlined access to Novo Nordisk’s FDA-approved GLP-1 medications, including Wegovy® (injectable and oral) and Ozempic®, at competitive cash-pay pricing. Patients receive a comprehensive, end-to-end experience that includes virtual visits with LifeMD’s affiliated medical group across all 50 states, ongoing clinical oversight, access to nationwide diagnostic testing, coordinated pharmacy fulfillment with fast shipping and real-time tracking, and simplified billing and payment.

“Innovation can only make a difference when people can access it. Our collaboration with LifeMD gives patients a trusted telehealth option where they can connect with a healthcare provider and begin authentic, FDA-approved treatment,” said Dave Moore, Executive Vice President, U.S. Operations, Novo Nordisk. “It’s another way we’re meeting people where they receive care and with the first and only FDA-approved oral GLP-1, Wegovy® pill offers patients convenience and choice.”

All doses of the Wegovy® pill are available by prescription to eligible LifeMD patients who are uninsured or whose insurance does not cover prescription weight-loss medications. Wegovy® 1.5mg and 4mg pills are available to patients at $149 per month. After April 15, 2026, Wegovy® 4mg pills will be available at $199 per month, and the 9mg and 25mg pills will be available at $299 per month.

1 Wegovy prescribing information: https://www.novo-pi.com/wegovy.pdf 
2 Based on the trial product estimand: estimated efficacy in an idealized scenario in which all patients stayed on treatment and took no other weight loss therapies. Wharton S, Lingvay I, Bogdanski P, et al. Oral semaglutide 25 mg in adults with overweight or obesity. N Engl J Med. 2025; 393:1077-1087. DOI: 10.1056/NEJMoa2500969.

About LifeMD, Inc.

LifeMD® is a leading provider of virtual primary care. LifeMD offers telemedicine, access to laboratory and pharmacy services, and specialized treatment across more than 200 conditions, including primary care, men’s and women’s health, weight management, and hormone therapy. The Company leverages a vertically integrated, proprietary digital care platform, a 50-state affiliated medical group, a state-of-the-art affiliated compounding pharmacy, and a U.S.-based patient care center to increase access to high-quality and affordable care. For more information, please visit LifeMD.com.

Cautionary Note Regarding Forward Looking Statements

This news release includes forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended; Section 21E of the Securities Exchange Act of 1934, as amended; and the safe harbor provision of the U.S. Private Securities Litigation Reform Act of 1995. Forward-looking statements contained in this news release may be identified by the use of words such as: “believe,” “expect,” “anticipate,” “project,” “should,” “plan,” “will,” “may,” “intend,” “estimate,” “predict,” “continue,” and “potential,” or, in each case, their negative or other variations or comparable terminology referencing future periods. Examples of forward-looking statements include, but are not limited to, statements regarding our financial outlook and guidance, short and long-term business performance and operations, future revenues and earnings, regulatory developments, legal events or outcomes, ability to comply with complex and evolving regulations, market conditions and trends, new or expanded products and offerings, growth strategies, underlying assumptions, and the effects of any of the foregoing on our future results of operations or financial condition.

Forward-looking statements are not historical facts and are not assurances of future performance. Rather, these statements are based on our current expectations, beliefs, and assumptions regarding future plans and strategies, projections, anticipated and unanticipated events and trends, the economy, and other future conditions, including the impact of any of the aforementioned on our future business. As forward-looking statements relate to the future, they are subject to inherent risk, uncertainties, and changes in circumstances and assumptions that are difficult to predict, including some of which are out of our control. Consequently, our actual results, performance, and financial condition may differ materially from those indicated in the forward-looking statements. These risks and uncertainties include, but are not limited to, “Risk Factors” identified in our filings with the Securities and Exchange Commission, including, but not limited to, our most recently filed Annual Report on Form 10-K, Quarterly Reports on Form 10-Q, and any amendments thereto. Even if our actual results, performance, or financial condition are consistent with forward-looking statements contained in such filings, they may not be indicative of our actual results, performance, or financial condition in subsequent periods.

Any forward-looking statement made in the news release is based on information currently available to us as of the date on which this release is made. We undertake no obligation to update or revise any forward-looking statement, whether as a result of new information, future events, or otherwise, except as may be required under applicable law or regulation.

Investor Contact:
Marc Benathen, Chief Financial Officer
marc@lifemd.com  

Media Contact:
Jessica Friedeman, Chief Marketing and Product Officer
press@lifemd.com

Kriya Appoints Sachiyo Minegishi as Chief Financial Officer

Kriya Appoints Sachiyo Minegishi as Chief Financial Officer




Kriya Appoints Sachiyo Minegishi as Chief Financial Officer

Seasoned biotech executive with a track record of guiding corporate development, financial strategy and commercialization for public and private biopharma companies

RESEARCH TRIANGLE PARK, N.C., Jan. 05, 2026 (GLOBE NEWSWIRE) — Kriya Therapeutics, Inc. (“Kriya”), a clinical-stage biopharmaceutical company developing life-changing gene therapies for conditions affecting millions of people around the world, today announced the appointment of Sachiyo Minegishi as Chief Financial Officer. Ms. Minegishi will oversee execution of Kriya’s corporate strategy, scaling of financial operations and planning for commercialization as the company advances multiple gene therapies through the clinic.

“Sachiyo brings sophisticated financial leadership as well as deep corporate development and commercialization experience in science-driven organizations. She has a strong understanding of how to scale biotech companies while maintaining a durable financial foundation,” said Shankar Ramaswamy, M.D., Co-Founder and CEO of Kriya. “We are pleased to welcome Sachiyo to the Kriya executive team and look forward to her leadership during this next chapter of transformational growth at the company.”

Ms. Minegishi added, “Kriya’s mission to make gene therapies accessible could redefine the modality and deliver value to millions of patients and their families. I am excited to join Kriya at this pivotal stage as they progress multiple programs through the clinic and look forward to helping the team deliver on its mission.”

With more than two decades of biopharma experience, Ms. Minegishi has a proven track record of executive leadership—guiding financial strategy, capital markets execution, corporate development and commercial strategy to advance and launch therapeutics across public and private companies. She most recently served as the Chief Operating Officer at Rectify Pharma where she led execution across key areas of corporate strategy, finance and operations.

Prior to Rectify, Ms. Minegishi was the Chief Financial Officer at Akouos (acquired by Eli Lilly), and before this led cross-functional global development of a portfolio of gene therapies for Sickle Cell Disease at bluebird bio. Earlier in her career, Ms. Minegishi held leadership roles at Aegerion, Human Genome Sciences, Genzyme and Amgen, after beginning her career in investment banking at Merrill Lynch. Ms. Minegishi earned a B.S. in Chemical Engineering and Economics from the Massachusetts Institute of Technology and an M.B.A. from the Wharton School of the University of Pennsylvania.

About Kriya Therapeutics
Our mission is to revolutionize medicine, with the ultimate goal of eliminating human suffering and enabling people to live without the burden of disease. Kriya is a clinical-stage biopharmaceutical company developing gene therapies to address chronic diseases affecting millions of people around the world. Our pipeline includes potentially transformational medicines in multiple therapeutic areas—including in ophthalmology, metabolic disease and neurology—built on our fully-integrated proprietary manufacturing and engineering platform. For more information, please visit www.kriyatx.com and follow us on LinkedIn and Twitter.

CONTACT: Media Contact:
Kelli Perkins
kelli@redhousecomms.com

Weight Watchers Expands Its Integrated GLP-1 Platform with Access to Wegovy® Pill Advancing a New Standard for Long-Term Weight Health

Weight Watchers Expands Its Integrated GLP-1 Platform with Access to Wegovy® Pill Advancing a New Standard for Long-Term Weight Health




Weight Watchers Expands Its Integrated GLP-1 Platform with Access to Wegovy® Pill Advancing a New Standard for Long-Term Weight Health

A NovoCare® Recognized Care Provider, Weight Watchers’ new Med+ program delivers an integrated GLP-1 care model proven to drive greater weight loss results than medication alone

NEW YORK, Jan. 05, 2026 (GLOBE NEWSWIRE) — WW International, Inc. (NASDAQ: WW) (“Weight Watchers”), the global leader in science-backed weight health, today announced access to Novo Nordisk’s newly FDA approved oral formulation of Wegovy® through its integrated GLP-1 platform. The addition of a once-daily Wegovy pill expands access to GLP-1 treatment and reinforces Weight Watchers’ leadership in delivering comprehensive care models that help people succeed on medication in real life by pairing medical therapy with evidence-based behavior change and ongoing support.

Weight Watchers, through its affiliated Weight Watchers Clinic, is a NovoCare® Recognized Care Provider based on its demonstrated ability to deliver FDA-approved GLP-1 medications alongside expert clinical care. Through Weight Watchers Med+ and the GLP-1 Success Program, the company delivers differentiated real-world outcomes by combining access to board-certified physicians and clinicians, evidence-based behavioral science, coaching and community support, and purpose-built digital tools. Together this integrated care model helps members stay engaged, manage side effects, and achieve meaningfully better results than medication alone.

“The next era of weight health isn’t about access to medication alone, it’s about helping people succeed on it,” said Tara Comonte, CEO of Weight Watchers. “For decades, Weight Watchers has shown that support drives results and we’re seeing that same truth play out in the GLP-1 era. By pairing access to GLP-1 medications with our proven guidance, structure, and community support, we’re helping people achieve far greater results. Expanding access to Wegovy® pill, a long-anticipated alternative to injectable GLP-1s, is an exciting next step.”

Through its integrated platform, Weight Watchers supports people using GLP-1 therapy, with structured behavioral programs designed to improve outcomes—whether medication is prescribed through Weight Watchers Med+ or elsewhere.

Weight Watchers’ integrated model has demonstrated meaningful real-world outcomes. At one month, Weight Watchers Med+ members prescribed a GLP-1 who regularly engaged with the GLP-1 Success Program lost 61.3% more body weight, on average, than those who did not engage in the behavioral support program. At twelve months, engaged Med+ members lost 29.1% more weight than those who used GLP-1s without corresponding behavioral support. These results underscore the importance and impact of pairing GLP-1 therapy with evidence-based programs designed to deliver better outcomes over time.*

“Collaborations with companies like Novo Nordisk are central to expanding access while ensuring patients are supported beyond the prescription,” said Scott Honken, Chief Commercial Officer at Weight Watchers. “Together, we’ve aligned around education, access, pricing, and pharmacy integration to help patients understand how to use oral GLP-1s effectively and ensure they have the guidance and structure needed to succeed.”

“As the first and only oral GLP-1 medication approved by FDA for the treatment of obesity and overweight who also have weight-related medical problems, Wegovy Pill is the most recent example of Novo Nordisk’s steadfast commitment to innovation in obesity care,” said Dave Moore, Executive Vice President, US Operations at Novo Nordisk. “We are confident that this innovation will increase access to the millions of patients who remain untreated, fitting into their daily routines and preferences which is an area that Weight Watchers has well established expertise.”

With the introduction of Wegovy® pill, Weight Watchers further expands access to GLP-1 treatment that offers a once-daily option that may appeal to individuals who have been hesitant or unable to begin injectable therapies. Weight Watchers Med+ members can access the oral formulation starting at $149 per month, providing a more accessible entry point for individuals seeking clinically supported, evidence-based weight health care.

As GLP-1 adoption accelerates, Weight Watchers remains focused on offering access to safe, FDA approved solutions grounded in clinical integrity and real-world support. By offering access that pairs medication with proven behavioral programs, Weight Watchers is helping more people not only start treatment—but achieve better results with it.

ABOUT WEIGHT WATCHERS
Weight Watchers is the global leader in science-backed weight management, offering an integrated support system built for the GLP-1 era that combines scientific expertise, medication, cutting-edge technology, and human connection. With more than 60 years of experience, Weight Watchers is the most studied commercial weight management program in the world, delivered through its No. 1 U.S. doctor-recommended weight-loss program. Its holistic, personalized approach also includes U.S.-based clinical interventions and access to GLP-1 medications when clinically appropriate, and a global network of coaches and community support. Since 1963, the company has led with science to deliver its members the personalized support they need to reach and sustain their goals. Members can access these solutions directly, or through Weight Watchers for Business’ full-spectrum platform for employers, health plans, and payers. In a landscape crowded with contradictory advice, isolating apps, and one-size-fits-all solutions, Weight Watchers offers a proven path forward that is rooted in research, grounded in empathy and designed to help every member feel better in their body and live a longer, healthier life. For more information, visit weightwatchers.com.

ABOUT NOVO NORDISK
Novo Nordisk is a leading global healthcare company with a heritage of more than 100 years in diabetes care. Building on this foundation, our purpose is to drive change to defeat serious chronic diseases — from diabetes and obesity to rare blood and endocrine disorders — by pioneering scientific breakthroughs, expanding access to medicines, and working to prevent and ultimately cure disease. We are committed to long-term, responsible business practices that deliver financial, social and environmental value. Headquartered in Denmark and operating in around 80 countries, Novo Nordisk employs approximately 78,500 people and markets products in roughly 170 countries. In the United States, Novo Nordisk has a 40-year presence, is headquartered in New Jersey and employs over 10,000 people across more than 10 manufacturing, R&D and corporate locations in eight states plus Washington, D.C. For more information, visit novonordisk.com and novonordisk-us.com, and follow us on Facebook, Instagram, X, LinkedIn and YouTube.

*Both outcomes were based on internal analyses of self-reported member data that has not been independently verified.

For media inquiries, please contact:
Lizzy Levitan 
WW@hunt-gather.com

For investor inquiries, please contact:
John Mills or Anna Kate Heller
WeightWatchers@icrinc.com

SynuSight Biotech, ABLi Therapeutics and XingImaging Announce Strategic Collaboration to Implement Alpha-Synuclein PET Imaging into Clinical Trials Evaluating Risvodetinib as a Disease-modifying Therapy for Parkinson’s Disease

SynuSight Biotech, ABLi Therapeutics and XingImaging Announce Strategic Collaboration to Implement Alpha-Synuclein PET Imaging into Clinical Trials Evaluating Risvodetinib as a Disease-modifying Therapy for Parkinson’s Disease




SynuSight Biotech, ABLi Therapeutics and XingImaging Announce Strategic Collaboration to Implement Alpha-Synuclein PET Imaging into Clinical Trials Evaluating Risvodetinib as a Disease-modifying Therapy for Parkinson’s Disease

SynuSight Biotech has licensed 18F-FD4 to XingImaging and to ABLi Therapeutics to evaluate alpha-synuclein clearance from the brain in response to risvodetinib treatment

SHANGHAI and ATLANTA and NEW HAVEN, Conn., Jan. 05, 2026 (GLOBE NEWSWIRE) — SynuSight Biotech (“SynuSight”), a biotechnology company dedicated to the development of diagnostic solutions for neurodegenerative diseases and ABLi Therapeutics (“ABLi”), a biotechnology company developing disease-modifying therapeutics in Parkinson’s disease, have entered into non-exclusive clinical use license agreement that permits ABLi to utilize 18F-FD4 (“FD4”) in its trials to evaluate risvodetinib as a disease-modifying therapy for Parkinson’s disease (PD).

SynuSight pioneered the development of the alpha-synuclein aggregate-specific PET tracer FD4 to visualize alpha-synuclein pathology in human brain. As part of this licensing collaboration, SynuSight will receive an upfront payment and subsequent license-related fees from ABLi. As part of the collaboration, XingImaging will become the U.S.-based manufacturer of FD4 and marry it to the ultra-high resolution NeuroEXPLORER, a next generation dedicated brain PET imager housed at Xing’s newly established imaging facility in New Haven, CT.

ABLi will leverage the ability of FD4 to visualize alpha-synuclein pathology in the central nervous system to complement the novel blood-borne and tissue biomarkers developed by ABLi and its collaborators, establishing an integrated framework for comprehensive evaluation of the therapeutic effects of risvodetinib in PD. ABLi plans to implement FD4 in two clinical trials in 2026. The first, ABILITY-PD, plans to re-enroll the 120 participants in the Phase 2a 201 Trial completed in 4Q24 to measure the effect of risvodetinib treatment on biomarkers from brain, blood and tissue in a 12-month longitudinal biomarker study. ABILITY-PD will also collect motor, non-motor and dopamine transporter-specific functional data to evaluate how changes in biomarkers throughout the body correlate with functional outcomes in response to treatment. The second, the c-Abl inhibitor Modification of Parkinson’s Disease (CAMPD) trial, a Phase 2b/3 trial, will evaluate the efficacy of risvodetinib in a double-blind, placebo controlled trial in up to 500 participants with untreated Parkinson’s disease.

“This collaboration represents a key milestone in the global development of FD4. By integrating molecular imaging technologies with rigorously designed clinical trials and longitudinal follow-up, the partnership aims to directly interrogate the disease-modifying potential at the pathological level,” said SynuSight CEO Roger Fan.

“ABLi has been expanding its portfolio of disease-related biomarkers, with both blood-borne and tissue measures of alpha-synuclein pathology and is excited to add alpha-synuclein PET imaging to this panel to expand our understanding of the potential disease-modifying effect of risvodetinib in PD,” said Dr. Milton Werner, Chairman and Chief Executive of ABLi.

“This represents a pivotal opportunity to advance one of the most promising alpha-synuclein PET tracers in humans with the potential disease-modifying effect of risvodetinib in PD,” said Gilles Tamagnan, CEO of XingImaging.

About Risvodetinib (ABLi-148009)
Risvodetinib is a potent, selective small-molecule inhibitor of the non-receptor c-Abl kinases, designed for once-daily oral use that targets the underlying biological mechanisms driving Parkinson’s disease initiation and progression. Risvodetinib is believed to be a disease-modifying therapy that halts disease progression and reverses the functional loss arising from Parkinson’s disease inside and outside of the brain. All marketed therapeutic approaches to treat Parkinson’s help manage the symptoms of the disease, but there are currently no available treatments to slow or stop the disease’s relentless progression. Recently, risvodetinib was the first monotherapy shown to improve patient quality of life in a randomized, placebo-controlled clinical trial (NCT NCT05424276) and simultaneously reduced the underlying synuclein aggregate pathology in untreated Parkinson’s disease. Risvodetinib currently has intellectual property protection beyond 2036.

About 18F-FD4
18F-FD4 is a selective, high-affinity PET tracer developed by SynuSight to image pathogenic α-synuclein in Parkinson’s disease and related α-synucleinopathies. 18F-FD4 has demonstrated efficient blood-brain barrier penetration, a clear and stable imaging window with rapid washout, low off-target binding, and favorable safety in both preclinical studies and investigator-initiated trials at Huashan Hospital. In patients with PD and MSA, 18F-FD4 has consistently produced high-contrast signals in pathology-relevant brain regions and shown robust disease-differentiation performance (see image). In 2025, 18F‑FD4 received a $3.84 million research grant from the Michael J. Fox Foundation for Parkinson’s Research (MJFF)—the world’s largest nonprofit philanthropy of PD research—to support its U.S. clinical registration and development, underscoring the strong scientific rationale and clinical potential of this novel α-synuclein PET tracer. This funding award highlights the confidence of leading international research institutions in 18F-FD4 as a next-generation imaging biomarker, and clinical development is expected to begin in both the U.S. and China in the first quarter of 2026.

Photo

About ABLi Therapeutics
ABLi Therapeutics (“ABLi”) applies innovative medicinal chemistry and a deep understanding of disease biology to develop small molecule therapeutics that target the cause of diseases that arise from activation or dysfunction of the Abelson Tyrosine Kinases (c-Abl). Leveraging its expertise in drug design, ABLi utilizes clinically validated data of kinase inhibitors to design and develop novel product candidates with enhanced penetration into the brain, greater potency and target selectivity, and improved safety to treat diseases in which Abl kinase activation or dysfunction is implicated. The Company’s primary focus is on developing therapeutics for the treatment of neurodegenerative diseases like Parkinson’s disease and the Parkinson’s-related neurodegenerative diseases Multiple System Atrophy and Dementia with Lewy Body, that are all associated with Abl kinase activation or dysfunction. For more information visit www.ablitherapeutics.com or follow us on LinkedIn.

About XingImaging
XingImaging provides services across the pre-clinical and clinical spectrum including radioligand development and manufacturing, design and implementation of Phase 1 to Phase 4 clinical trials, and customized clinical imaging site coordination and management in multi-site imaging studies. Xing’s strong emphasis is on research using investigational radiotracers with quantitative imaging outcome measures as diagnostic tools and/or for assessing disease mechanism or progression. Xing focuses on developing radioligands as tools for human research aimed at advancing clinical neuroscience and nuclear medicine to understand the causes and develop more effective treatments for neurodegenerative disorders.

About SynuSight Biotech
SynuSight Biotech is committed to pioneering transformative diagnostic solutions for neurodegenerative diseases through cutting-edge scientific expertise and innovative technology platforms, ultimately benefiting millions of patients worldwide. SynuSight specializes in studying the misfolding and pathological aggregation of proteins such as alpha-synuclein, tau, and A-beta. By integrating cutting-edge technologies like Cryo-EM electron diffraction, helical filament imaging, and In-cell NMR spectroscopy, we have built unparalleled expertise in key neurodegenerative disease targets, unlocking new possibilities for innovative therapeutic solutions development.

Contacts:

For ABLi Therapeutics
info@ablitherapeutics.com

For XingImaging
info@xingimaging.com

For SynuSight Biotech
info@synusight.com

Investor/Media
Mike Moyer
Managing Director – LifeSci Advisors
mmoyer@lifesciadvisors.com

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/0ebb1518-1452-44f1-9637-9e9f64f66132