Biomea Fusion Presents Phase II COVALENT-111 Data in Type 2 Diabetes at the 19th International Conference on Advanced Technologies & Treatments for Diabetes 2026

Biomea Fusion Presents Phase II COVALENT-111 Data in Type 2 Diabetes at the 19th International Conference on Advanced Technologies & Treatments for Diabetes 2026




Biomea Fusion Presents Phase II COVALENT-111 Data in Type 2 Diabetes at the 19th International Conference on Advanced Technologies & Treatments for Diabetes 2026

SAN CARLOS, Calif., March 14, 2026 (GLOBE NEWSWIRE) — Biomea Fusion, Inc. (“Biomea,” “Biomea Fusion,” or the “Company”) (Nasdaq: BMEA), a clinical-stage diabetes and obesity company, today announced that Juan Pablo Frías, MD, delivered an oral presentation at the 19th International Conference on Advanced Technologies & Treatments for Diabetes (“ATTD”) in Barcelona on March 14, 2026 highlighting positive 52-week follow-up results from the Company’s Phase II COVALENT-111 study evaluating the efficacy, safety, and tolerability of icovamenib in patients with type 2 diabetes (“T2D”).

“We are encouraged by the durability of icovamenib’s effect observed nine months post-dosing at Week 52,” said Mick Hitchcock, Ph.D., Interim CEO and Board Member of Biomea Fusion. “We believe that we now have in hand initial evidence of durable efficacy, additional favorable safety data, a clear understanding of an effective dose, and most importantly, the target patient populations. We believe icovamenib demonstrates potential to transform the diabetes treatment landscape by effectively addressing the underlying biology. We are excited about the upcoming two new Phase II studies which are designed to specifically address those patients that had the best responses in our trial COVALENT-111.”

COVALENT-111 Study Design and Results
COVALENT-111 was a double-blind, randomized, placebo-controlled trial that enrolled adult patients diagnosed with T2D within the last seven years. Eligible participants had HbA1c levels between 7.0% and 10.5%, and a body mass index (“BMI”) between 25 and 40 kg/m². At baseline, all participants were treated with lifestyle management, including diet and exercise, with or without antidiabetic medications and had inadequate glycemic control despite treatment with up to three antidiabetic medications.

The study evaluated icovamenib in three dosing regimens: Arm A at 100mg QD (once daily) for 8 weeks, Arm B at 100mg QD for 12 weeks, and Arm C at 100 mg QD for 8 weeks and 100mg BID (twice daily) for 4 weeks. A total of 267 patients received at least one dose of icovamenib and were considered evaluable for the modified intent-to-treat population. As previously reported, study dosing was temporarily interrupted due to a clinical hold imposed by the U.S. Food and Drug Administration. The topline efficacy analysis presented here includes the patient population (N=163) who had completed at least 80% of their planned dosing prior to the clinical hold (without other significant protocol deviations) and who, at baseline, were treated with one or more antihyperglycemic agents. As prespecified in the statistical analysis plan, outcomes were prospectively evaluated by diabetes phenotype using the Ahlqvist algorithm.

The study showed positive results, while exploratory, through Week 52 across multiple subgroups, with certain groups demonstrating statistically significant and clinically meaningful reductions in HbA1c, the gold standard for assessing glycemic control in T2D, observed nine months after dosing. In the 26-week analysis, 8 weeks of dosing was found to be less effective than 12. Accordingly, the 52-week readout primarily focused on patients in Arms B and C who received 12 weeks of treatment. Among the severe insulin-deficient patients (n=10), icovamenib achieved anHbA1c reduction that improved over time reaching 1.2% at Week 52 ((p=0.01 vs placebo). The strongest performing arm for this prespecified population was Arm B (n=6; 100mg QD for 12 weeks), with a mean HbA1c reduction of 1.5% (p=0.01). Severe insulin-deficient diabetes (“SIDD”) is characterized by impaired insulin secretion, the lowest beta cell function among T2D subtypes, and rapid disease progression. This group was prospectively defined prior to unblinding and represents a population with substantial unmet need. In this subgroup, C-peptide index fold change increased by 24% from baseline, suggesting improved endogenous insulin secretion.

The 52-week analysis also showed clinically meaningful glycemic improvement in study participants who were receiving a GLP-1-based therapy but had not achieved glycemic targets at study entry (all arms n=12). In this subgroup, 8 or 12 weeks of icovamenib treatment resulted in HbA1c reduction that improved over time reaching 1.2% at Week 52 (p=0.05 vs placebo). C-peptide index fold change increased by 35% from baseline in this subgroup, further supporting improvement in beta cell function.

Icovamenib maintained a favorable safety profile throughout the 52-week observation period.
There were no treatment-related serious adverse events or discontinuations due to adverse events. Across all dosing arms, icovamenib was generally well tolerated.

ATTD 2025 Presentation:
The abstract will be published in the peer-reviewed Journal of Diabetes Technology & Therapeutics. The presentation will be available on Biomea Fusion’s Investor Relations Page under the Events section https://investors.biomeafusion.com/news-events.

Key Anticipated Milestones
Icovamenib – Diabetes

  • 52-week follow-up data from type 1 diabetes (“T1D”) patients in COVALENT-112 who completed ≥80% of protocol-specified dosing with the read-out expected in the second quarter of 2026.
  • 26-week primary endpoint data from the Phase II COVALENT-211 and COVALENT-212 studies anticipated in the fourth quarter of 2026.

BMF-650 – Obesity

  • Initial 28-day clinical weight-reduction data from Phase I GLP-131 study anticipated in the second quarter of 2026.

About Icovamenib
Icovamenib is an orally administered investigational small molecule in clinical development for the treatment of diabetes. Icovamenib targets menin, a transcriptional regulator implicated in beta-cell dysfunction, and has been observed to induce transient reductions in menin protein levels in pancreatic islets, thereby modulating pathways associated with insulin secretion and glycemic control. As a potential short course therapy, icovamenib could become an important addition to the diabetes treatment landscape particularly addressing those patients that failed their standard of care therapies.

About Menin’s Role in Diabetes
Loss of functional beta cell mass is a core component of the natural history in both types of diabetes — T1D (mediated by autoimmune dysfunction) and T2D (mediated by metabolic dysfunction). Beta cells are found in the pancreas and are responsible for the synthesis and secretion of insulin. Insulin is a hormone that helps the body use glucose for energy and helps control blood glucose levels. In patients with diabetes, beta cell mass and function have been observed to be diminished, leading to insufficient insulin secretion and hyperglycemia. Menin is thought to act as a regulatory brake on beta cell turnover and growth, supporting the hypothesis that menin inhibition may enable regeneration of functional cells. Based on these and other scientific findings, Biomea is exploring the potential for icovamenib-mediated menin inhibition as a viable therapeutic approach to potentially halt or reverse progression of T2D.

About Type 2 Diabetes and Severe Insulin-Deficient Diabetes
Diabetes is considered a chronic health condition that affects how the body turns food into energy and results in excessive glucose in the bloodstream. Over time, this can cause serious health problems and damage vital organs. Most people with diabetes have a shorter life expectancy than people without this disease. According to the Centers for Disease Control and Prevention, more than 38 million Americans (~11% of the population) have diabetes, and 98 million adults have prediabetes. Diabetes also represents one of the largest economic burdens on the U.S. healthcare system, with approximately one in four healthcare dollars spent on diabetes care. Within the population of people with T2D, SIDD is a clinically recognized subtype of T2D characterized by profoundly impaired insulin secretion (significantly reduced beta cell function) and poor glycemic control. People with diabetes with severe insulin deficiency often present with higher HbA1c levels at diagnosis, lower BMI compared to insulin-resistant patients, and a rapid decline in beta cell function. This group represents a very high unmet medical need, with the highest risk of complications such as retinopathy and neuropathy and typically progresses the fastest to insulin therapy. Addressing the underlying beta cell dysfunction in this population offers an important opportunity to slow or potentially reverse disease progression.

About Biomea Fusion  
Biomea Fusion is a clinical-stage biopharmaceutical company focused on the development of its oral small molecule therapies, icovamenib and BMF-650, for diabetes and obesity. These programs target metabolic disorders, a global health challenge affecting nearly half of Americans and one-fifth of the world’s population. Biomea’s mission is to deliver transformative treatments that restore health for patients living with diabetes, obesity, and related conditions. We aim to cure.

Visit us at www.biomeafusion.com and follow us on LinkedIn, X and Facebook

Forward-Looking Statements
Statements we make in this press release may include statements which are not historical facts and are considered forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended (the “Securities Act”), and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”). These statements may be identified by words such as “aims,” “anticipates,” “believes,” “could,” “estimates,” “expects,” “forecasts,” “goal,” “intends,” “may,” “plans,” “possible,” “potential,” “seeks,” “will,” and variations of these words or similar expressions that are intended to identify forward-looking statements. Any such statements in this press release that are not statements of historical fact, including statements regarding the clinical and therapeutic potential of our product candidates and development programs, including icovamenib and BMF-650, the potential of icovamenib as a treatment for T1D and T2D, the potential of BMF-650 as a treatment for obesity; our research, development and regulatory plans; the mechanism of action of our product candidates and development programs; the progress and initiation of our ongoing and upcoming clinical trials, including our Phase II (COVALENT-111) study, our Phase IIb (COVALENT-211) study, our Phase IIb (COVALENT-212) study and our Phase I (GLP-131) study; the anticipated availability of data from our clinical trials; our planned interactions with regulators, and the timing of such events may be deemed to be forward-looking statements. We intend these forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 27A of the Securities Act and Section 21E of the Exchange Act and are making this statement for purposes of complying with those safe harbor provisions. Any forward-looking statements in this press release are based on our current expectations, estimates and projections only as of the date of this release and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements, including the risk that preliminary or interim results of preclinical studies or clinical trials may not be predictive of future or final results in connection with future clinical trials and the risk that we may encounter delays in preclinical or clinical development, patient enrollment and in the initiation, conduct and completion of our ongoing and planned clinical trials and other research and development activities. These risks concerning Biomea Fusion’s business and operations are described in additional detail in its periodic filings with the U.S. Securities and Exchange Commission (“SEC”), including its most recent periodic report filed with the SEC and subsequent filings thereafter. Biomea Fusion explicitly disclaims any obligation to update any forward-looking statements except to the extent required by law.

Contact:
Meichiel Jennifer Weiss
Sr. Director of Investor Relations and Corporate Development
ir@biomeafusion.com 

AgelessRx 2026: Longevity Telehealth Platform Overview — Treatments, Pricing, Compounded Medications, and What Prospective Patients Should Know

AgelessRx 2026: Longevity Telehealth Platform Overview — Treatments, Pricing, Compounded Medications, and What Prospective Patients Should Know




AgelessRx 2026: Longevity Telehealth Platform Overview — Treatments, Pricing, Compounded Medications, and What Prospective Patients Should Know

An Informational Consumer Analysis of AgelessRx’s Prescription Process, NAD+ Therapies, GLP-1 and Compounded Semaglutide Options, Off-Label Longevity Medications, and Cash-Pay Pricing Structure for 2026

Ann Arbor, MI, March 13, 2026 (GLOBE NEWSWIRE) — Disclaimer: This article is for informational and educational purposes only and does not constitute medical advice, diagnosis, or treatment recommendations. According to the company, AgelessRx operates as a telehealth platform connecting users with licensed healthcare providers and pharmacy partners. Prescription approval is not guaranteed and depends on individual medical history, eligibility, and provider assessment. Individual experiences may vary. This article may contain affiliate links, and if a qualifying action is taken through those links, a commission may be earned at no additional cost to the reader. All treatment availability, pricing, and service details should be verified directly on the official AgelessRx platform before making any health-related decision.

As consumer interest in preventive healthcare and longevity-focused care continues to grow in 2026, telehealth platforms discussing age-related wellness and metabolic health have attracted increased scrutiny from both consumers and regulators. According to the company, AgelessRx operates as a telehealth platform that connects users with licensed healthcare providers who may evaluate patients for certain prescription and wellness-related options when clinically appropriate. This consumer research report examines the platform’s operational structure, treatment catalog, pricing transparency, and regulatory considerations to help readers better understand how the service is described by the company.

AgelessRx 2026 Longevity Telehealth Platform Overview — Treatments, Pricing, Compounded Medications, and What Prospective Patients Should Know

Key Takeaways: What Consumers Should Know About AgelessRx

Before exploring the platform in detail, here are the most important things to understand upfront:

  • Prescription Requirement: All AgelessRx treatments require review and approval by US-licensed healthcare providers. You cannot simply purchase medications without a formal medical review.
  • Treatment Scope: According to company materials, the platform offers 45+ treatments across longevity, weight management, energy optimization, cardiovascular health, and cognitive function categories. According to the company, all prescriptions are filled by 503A compounding pharmacies that the company states are FDA-registered and state-licensed.
  • Off-Label Prescribing: Many longevity treatments — including metformin, rapamycin, low-dose naltrexone, and daily tadalafil — are manufactured in FDA-registered facilities for specific approved conditions but are prescribed off-label within longevity-focused or age-related wellness discussions. This is legal and common, but it does mean these medications are being used outside their originally approved indications.
  • Pricing Structure: According to company materials, treatments range from $25/month for metformin to $949 for multi-cancer detection testing. The platform does not accept insurance, though HSA/FSA cards may be accepted at checkout according to company materials.
  • Service Model: According to the company, the process starts with an online medical intake, followed by a provider review of your history. If approved, prescriptions are shipped in discreet packaging with free delivery. Some states require video consultations as part of the intake process.

For those considering AgelessRx for longevity-focused healthcare, View the current AgelessRx offer (official AgelessRx page) to verify treatment availability in your state and review the complete intake requirements before starting the process.

In This Analysis

This report covers the following aspects of the AgelessRx platform:

  • What AgelessRx is and how the telehealth consultation process works
  • A complete treatment catalog breakdown by category
  • Prescription fulfillment protocols and pharmacy partner certifications
  • Clinical evidence for longevity-focused off-label prescribing
  • Pricing analysis based on company materials
  • Customer experience context from third-party review platforms
  • Regulatory considerations and the compliance framework
  • Use-case considerations and platform limitations

Understanding AgelessRx: Telehealth Platform Structure and Service Model

What exactly is AgelessRx, and how does it differ from traditional healthcare? According to the company, AgelessRx operates as a telehealth platform specializing in preventive healthcare for both lifespan and healthspan. The platform connects patients with US-licensed healthcare providers who evaluate medical histories and, when clinically appropriate, may prescribe treatments aimed at supporting healthspan rather than simply treating diagnosed diseases.

Here’s the distinction that matters most: AgelessRx is not a pharmacy, clinic, or medical practice. It is a technology platform that facilitates connections between patients and independent healthcare providers. The providers make all prescribing decisions independently. AgelessRx coordinates the intake process, prescription fulfillment through pharmacy partners, and ongoing patient support — but clinical judgment belongs entirely to the licensed clinicians.

This three-entity model — patient, independent provider, pharmacy partner — is standard in telehealth, but it often confuses first-time users. You are not receiving prescriptions “from AgelessRx.” You are receiving prescriptions from licensed clinicians who work through the platform. AgelessRx handles the logistics, but the medical decisions stay with the providers.

The Five-Step Process: How AgelessRx Works From Intake to Delivery

According to company materials, the AgelessRx process follows this structure:

Step 1: Treatment Selection. You browse the treatment catalog and select the therapies that align with your health goals. The platform organizes treatments across categories including energy optimization, weight management, cardiovascular health, cognitive function, and cellular aging. Each treatment page includes mechanism descriptions, dosing information, and eligibility criteria.

Step 2: Online Medical Intake. You complete a detailed health questionnaire covering lifestyle factors, medical history, current medications, and treatment goals. You will also provide government-issued identification, a recent photo, and payment information. According to the company, charges only apply upon prescription approval — so you are not paying upfront for a consultation that might result in a denial.

Step 3: Provider Medical Review. US-based clinicians evaluate your intake responses against the clinical criteria for each requested treatment. Some states require live video consultations; others permit asynchronous review. The company states that reviews typically take place within five business days. If approved, prescriptions are transmitted to certified pharmacy partners at FDA-registered facilities.

Step 4: Prescription Fulfillment and Delivery. According to the company, approved prescriptions are filled by 503A compounding pharmacies and shipped in discreet packaging at no delivery charge. According to company materials, most orders ship within five to seven business days after approval. Order tracking is available through a HIPAA-compliant patient portal.

Step 5: Ongoing Clinical Support. The platform provides on-demand access to providers and support staff for questions, dosage adjustments, and side effect management. According to the company, automatic refills are available, and subscribers can pause or cancel at any time.

Compared to traditional healthcare, this model offers practical conveniences — no insurance billing complexity, no multi-week waits for specialist appointments, and no need to travel to a clinic. That said, it also means giving up the in-person physical examination, an established long-term patient-provider relationship, and the cost-sharing that insurance typically provides.

AgelessRx Treatment Catalog: 45+ Therapies Across Seven Categories

What can you actually get through AgelessRx? The platform’s catalog is broad, spanning prescription medications, compounded therapies, diagnostic testing, and evidence-based supplements. Here is the full breakdown by category, with pricing as stated by the company:

Injectable Therapies

According to company materials, AgelessRx offers eight injectable treatments focused on cellular metabolism, growth hormone support, and antioxidant pathways:

NAD+ Injection (starting at $235/month as of March 2026 per company materials): Presented by the company within discussions of cellular metabolism and age-related NAD+ decline. NAD+ is a coenzyme involved in cellular energy processes that the company notes decreases with age.

Sermorelin Injection (starting at $99/month): According to the platform, this growth hormone-releasing peptide is intended to encourage the body’s natural growth hormone production. It is prescribed off-label within longevity-focused or age-related wellness discussions, though its FDA approval covers diagnostic testing for growth hormone deficiency.

Glutathione Injection (starting at $99/month): Described by the company within discussions of immune support and oxidative-stress pathways, referencing the body’s primary endogenous antioxidant system.

Microdosing GLP-1 (starting at $99/month): Presented as a weight management support option using lower doses of GLP-1 receptor agonists, which the company suggests may reduce gastrointestinal side effects while preserving metabolic relevance.

Injectable GLP-1 Treatments (starting at $139/month): According to the company, these are physician-guided weight management programs using compounded semaglutide or tirzepatide formulations.

Compounded Liraglutide (starting at $149/month): Described as a daily injection option discussed in the context of metabolic health and weight management, using a different GLP-1 receptor agonist than semaglutide.

Injectable treatments require comfort with self-administration, proper refrigeration, and sharps disposal. For those who prefer to avoid injections, AgelessRx offers alternative delivery formats for several of these therapies.

Nasal Spray Formulations

For patients who prefer non-injectable delivery, the company offers three nasal spray options:

NAD+ Nasal Spray (starting at $125/month): According to company materials, this formulation is described as delivering NAD+ through nasal absorption, with the company stating that effects may occur within one hour. The 14ml bottle provides approximately 120 sprays for one to two daily doses and requires refrigeration.

Sermorelin Nasal Spray (starting at $199/month): Presented as supporting natural growth hormone signaling through nasal mucosa absorption. According to the company, it may promote deeper sleep and cognitive clarity, though these represent the platform’s descriptive framing rather than established clinical findings.

Glutathione Nasal Spray (starting at $100/month): Described by the platform within discussions of oxidative-stress support and cognitive wellness through direct nasal delivery.

Nasal sprays offer a convenient alternative to injections but may cause mild local irritation in some users. The company does not publish comparative bioavailability data between nasal and injectable formulations.

Transdermal Patch Technology

AgelessRx offers two iontophoresis-based patch systems designed for weekly transdermal delivery:

NAD+ Patches (starting at $160/month): According to the company, these battery-powered devices deliver 400mg of NAD+ through the skin into the bloodstream over a four-hour wear period. The platform recommends supplementing with 1,000mg of TMG (trimethylglycine) on patch days to support methylation.

Glutathione Patches (starting at $190/month): Described as delivering prescription-strength glutathione via once-weekly iontophoresis for systemic antioxidant support, according to company materials.

Patches eliminate the need for needles and daily dosing schedules, though they do require a four-hour wear window and battery management. The company positions these as a premium convenience option for patients who want a less hands-on routine.

Oral Prescription Medications

This category covers medications manufactured in FDA-registered facilities and prescribed off-label within longevity-focused contexts. This is also where the regulatory complexity becomes most relevant for prospective patients:

Metformin (starting at $25/month): Manufactured in FDA-registered facilities for Type 2 diabetes management, metformin is discussed by the company within a longevity context based on ongoing research interest in metabolism and age-related health pathways. Any use beyond its approved indication is off-label and subject to provider evaluation.

Rapamycin (starting at $65/month): Manufactured in FDA-registered facilities as an immunosuppressant for organ transplant recipients, rapamycin is presented by the company within a longevity context that the platform states requires ongoing monitoring and blood work. Off-label use in longevity discussions is based largely on animal research showing lifespan extension, but controlled human longevity data remains limited.

Low Dose Naltrexone (LDN) (starting at $25/month): Manufactured in FDA-registered facilities for opioid and alcohol addiction at 50mg doses, LDN is used here at 1.5–4.5mg for immune modulation purposes. According to the platform, it is discussed in the context of immune support, chronic wellness, and energy restoration — all of which represent off-label use that should be understood in that context.

Tadalafil Daily (starting at $60/month): Manufactured in FDA-registered facilities for specific approved indications, low-dose daily tadalafil is discussed by the company in relation to broader vascular and wellness-focused longevity discussions. This represents off-label prescribing and should be understood as such.

Methylene Blue (starting at $43/month): Manufactured in FDA-registered facilities for an approved medical use, this compound is described by the platform within broader discussions of cognitive and cellular research interest. The company specifically warns against use alongside SSRIs or MAOIs due to interaction risk.

These medications illustrate the core tension running through longevity medicine: they are prescription drugs with FDA approval for specific, well-established conditions, but their use in healthy-aging contexts represents off-label prescribing grounded in research interest rather than proven longevity outcomes in humans. Any prescribing provider should walk you through this distinction clearly before you begin.

Weight Management Programs

According to company materials, AgelessRx offers several weight management options built around GLP-1 receptor agonists:

Compounded Semaglutide (starting at $139/month): Described by the company as a physician-guided program using compounded formulations of the same active ingredient found in certain FDA-approved GLP-1 medications. Dosing typically starts low and is titrated upward based on individual tolerance and response.

Compounded Tirzepatide (starting at $249/month): According to the platform, this option is discussed in relation to weight management and metabolic support protocols. The company states it is compounded at certified 503A pharmacies.

Brand-Name Options: According to company materials, AgelessRx also facilitates access to Wegovy and Zepbound for patients who prefer FDA-approved finished formulations. Pricing varies based on manufacturer assistance programs and individual circumstances.

The company states that all weight management programs include provider oversight, dosing guidance, and ongoing side effect management. Individual results vary, and these medications are intended to be used as part of broader lifestyle modification efforts.

Diagnostic Testing

According to the company, AgelessRx offers several at-home testing options:

Galleri Multi-Cancer Early Detection ($949): Described by the company as a blood test that screens for 50+ cancer types through circulating tumor DNA analysis. According to company materials, it is positioned for adults aged 50 and older or those with elevated cancer risk factors.

Biological Age Testing (starting at $75): The platform offers epigenetic age testing through DNA methylation analysis. According to the company, results provide a comparison between biological age and chronological age.

Hormone Panels (pricing varies): According to the company, comprehensive hormone testing is available to inform treatment decisions related to testosterone, thyroid function, and other hormone optimization discussions.

Evidence-Based Supplements

The company offers several supplement formulations designed to complement its prescription therapies:

Longevity Bundle ($99/month): According to company materials, this bundle includes compounds such as NMN and resveratrol that the platform discusses in relation to longevity-focused research.

NAD+ Precursors (pricing varies): The platform offers NMN and NR supplements as alternatives or complements to its prescription NAD+ delivery options.

Methylation Support ($25/month): According to the company, TMG supplementation supports healthy methylation pathways — something the platform describes as particularly relevant for patients using NAD+ therapies.

For a complete overview of available treatments and current eligibility criteria, View the current AgelessRx offer (official AgelessRx page) to review the full catalog directly on the platform.

Prescription Fulfillment: Understanding Compounding Pharmacy Partnerships

One of the most common questions prospective patients ask about AgelessRx is straightforward: Where do the medications actually come from, and what quality assurance is in place?

According to company materials, AgelessRx partners exclusively with 503A compounding pharmacies that the company states are FDA-registered and state-licensed. These pharmacies are described by the company as operating under the following quality control standards:

  • FDA registration and regular inspection
  • State board of pharmacy licensing
  • USP (United States Pharmacopeia) compliance for compounding standards
  • Third-party testing for potency, purity, and sterility
  • HIPAA-compliant handling of patient information

An important distinction to understand: compounded medications are not the same as FDA-approved finished drugs. Compounding pharmacies create customized formulations based on individual physician prescriptions, but those formulations do not go through the same clinical trial and approval process as brand-name medications. This is legal and common throughout US healthcare, but it does mean the medications carry a different level of regulatory oversight than FDA-approved products.

For injectable therapies specifically, the company states that all formulations are prepared in sterile environments meeting USP 797 standards for sterile compounding. Temperature-sensitive medications are shipped with monitoring to ensure they remain stable during transit.

Clinical Evidence: What Research Supports Longevity Prescribing?

For most prospective patients, this is the most important question of all: Is there actual evidence that these treatments work for longevity?

The honest answer is more nuanced than a simple yes or no. Most longevity treatments available through AgelessRx fall into one of three categories:

Category 1: Strong animal research, limited human longevity data. Rapamycin, metformin, and NAD+ precursors have robust evidence in animal models demonstrating lifespan extension and healthspan improvements. Human studies show metabolic benefits and reduced disease risk markers, but no controlled trials have proven that these medications extend human lifespan. Choosing to use them is essentially a reasoned bet that findings in animal models will translate to humans — plausible based on the underlying mechanisms, but not yet proven.

Category 2: FDA-approved for specific conditions, prescribed off-label within longevity discussions. Tadalafil, low-dose naltrexone, and GLP-1 medications have well-established benefits for their approved indications. Their discussion in longevity contexts is grounded in mechanistic reasoning rather than dedicated longevity trials. Using them for this purpose is legal and practiced, but it does place you outside their formally proven use cases.

Category 3: Emerging research with preliminary human data. Senolytics, certain peptides, and some supplement combinations have early-stage human research suggesting potential benefit, but large-scale controlled trials are not yet available. Patients interested in these options are, in effect, evaluating therapies that are still in relatively early stages — some of which may become standard practice over time, and some of which may not.

The company provides research summaries for each treatment on the platform. What is worth keeping in mind is that “research-backed” in this context means there is scientific rationale and preliminary evidence — it does not mean a treatment has been proven to extend human lifespan in a clinical trial setting.

Pricing Analysis: What AgelessRx Actually Costs

According to company materials, AgelessRx pricing spans a wide range depending on which treatments are selected:

Entry-Level Treatments: Metformin ($25/month), low-dose naltrexone ($25/month), and basic supplements ($25–$50/month) represent the most affordable tier. These are oral medications with long safety track records and relatively straightforward production requirements.

Mid-Tier Treatments: NAD+ nasal spray ($125/month), sermorelin injections ($99/month), and compounded semaglutide ($139/month) sit in the moderate range. These involve more complex compounding processes or specialized delivery formats.

Premium Treatments: NAD+ injections ($235/month), compounded tirzepatide ($249/month), and transdermal patches ($160–$190/month) carry the highest monthly costs. These reflect sterile compounding requirements, specialized delivery technology, or higher-cost active ingredients.

One-Time and Periodic Costs: Diagnostic testing ranges from $75 for biological age testing to $949 for multi-cancer screening. These are generally annual or semi-annual expenses rather than recurring monthly costs.

According to the company, pricing covers provider consultations, prescription fulfillment, shipping, and ongoing clinical support. There are no separate consultation fees beyond the cost of the treatment itself.

Because AgelessRx is described as a cash-pay platform, you are paying full out-of-pocket pricing without insurance offset. The company notes that HSA and FSA cards may be accepted for eligible expenses, though you should confirm this directly with your plan administrator before making any assumptions about reimbursement.

Customer Experience: Third-Party Review Context

What do AgelessRx customers actually report about their experiences? Third-party review platforms offer some directional context, though it is important to interpret this kind of feedback with appropriate perspective.

Publicly visible third-party feedback reflects a mix of positive and critical experiences. Recurring themes include convenience of access, responsiveness of support staff, pricing clarity, prescription denials, and questions around the distinction between compounded and FDA-approved formulations. Because review platform feedback is self-selected and anecdotal, it should be treated as directional context rather than a representative picture of typical outcomes.

One pattern worth flagging directly: prescription denials appear consistently in publicly available feedback. This is not a flaw in the platform — it reflects how the system is actually designed. Approval depends entirely on provider assessment of your individual medical history, not on completing the intake form. Going in with that expectation set will make the experience more predictable regardless of the outcome.

Regulatory Framework: Understanding Telehealth and Compounding Pharmacy Oversight

How is AgelessRx regulated, and what consumer protections are in place?

The platform operates within several overlapping regulatory frameworks:

Telehealth Licensing: According to the company, all providers working through AgelessRx are licensed in the states where they prescribe. Telehealth regulations vary significantly by state — some require synchronous video consultations, while others permit asynchronous review. The platform must comply with the telemedicine rules specific to each state where it operates.

Pharmacy Licensing: The company states that partner compounding pharmacies are licensed in all 50 states and registered with the FDA. They operate under 503A regulations, which govern pharmacy compounding for individual patient prescriptions. This is a distinct regulatory category from 503B outsourcing facilities, which produce compounded medications in larger batch volumes.

HIPAA Compliance: As a healthcare platform handling protected health information, AgelessRx is required to comply with HIPAA privacy and security regulations. According to the company, all patient data is encrypted and stored in HIPAA-compliant systems.

FTC Oversight: Marketing claims about treatment benefits fall under FTC jurisdiction. Advertising off-label uses requires careful compliance with both FDA and FTC guidelines to avoid misleading consumers.

What Is Not Regulated the Same Way: The FDA does not review or approve individual compounded medications the way it approves finished manufactured drugs. Compounding pharmacies must meet quality standards, but the specific formulations they produce do not go through the FDA’s clinical review and approval process. This is an important distinction to understand before starting any compounded therapy.

Regulatory Context: The telehealth and compounded medication space has been the subject of ongoing regulatory attention in recent years. Consumers should review the most current information about any platform’s standing and compliance before proceeding. Verify current service availability and terms directly with AgelessRx before starting the intake process.

Use-Case Considerations and Platform Limitations

Based on the company’s stated service model, treatment catalog, and cash-pay structure, AgelessRx may be of interest to adults who are actively researching telehealth-based access to longevity-oriented or preventive care options. The platform format tends to be a better fit for consumers who are comfortable with remote intake, asynchronous provider review, and full out-of-pocket pricing.

At the same time, traditional in-person care is likely a more appropriate fit for some consumers — particularly those managing complex medical histories, those who want access only to FDA-approved finished drug pathways, those relying on insurance-based coverage, or those who value an ongoing relationship with an established physician. It is also worth noting that eligibility and prescribing decisions depend entirely on provider judgment and state-specific rules, which means not every treatment will be available or appropriate for every prospective patient.

Consumer Takeaway: Evaluating AgelessRx for Your Health Goals

According to the company, AgelessRx operates as a telehealth platform offering access to longevity-focused treatments through independent licensed healthcare providers and compounding pharmacy partners. For consumers interested in this space, the platform provides structured access to a broad range of options that are not always easy to access through traditional healthcare channels.

Here is a concise summary of the key considerations:

Treatment Access: According to the company, AgelessRx offers 45+ treatments across longevity, weight management, and preventive health categories. All treatments require individual provider approval — prescription is not guaranteed by completing the intake form.

Regulatory Framework: The company states that all providers are US-licensed and all pharmacy partners are FDA-registered and state-licensed. That said, compounded medications do not go through the same regulatory review process as FDA-approved finished drugs, and consumers should understand that distinction.

Clinical Evidence: Most longevity treatments discussed on this platform are supported by mechanistic rationale and animal research, but controlled human longevity data is limited. You are evaluating therapies based on scientific promise and early-stage evidence, not proven lifespan extension in clinical trials.

Cost Structure: According to company materials, most treatment pricing ranges from $25 to $300 per month, with no insurance coverage. HSA and FSA cards may be accepted for eligible expenses — confirm with your plan administrator.

Customer Experience: Publicly available third-party feedback reflects a range of outcomes. Because this feedback is self-selected and anecdotal, it should be weighed alongside direct verification with the platform rather than treated as representative of typical results.

Contact Information

For questions before or during the intake process, according to the company’s website, AgelessRx offers customer support through the following channels:

Phone: 650-503-9990
Email: info@agelessrx.com
Address: 2370 E Stadium Blvd #2049, Ann Arbor, MI 48104 USA

For those interested in learning more about the platform’s current treatment offerings, View the current AgelessRx offer (official AgelessRx page) to check state availability, review the full catalog, and review the intake process. Before starting any new prescription therapy — especially if you have existing health conditions or take other medications — consult your primary care provider first.

Important Information

This article is for informational purposes only and does not constitute medical advice, diagnosis, or treatment recommendations. AgelessRx is described by the company as a telehealth platform connecting users with licensed healthcare providers and pharmacy partners. Prescription approval depends on individual medical history, eligibility, provider assessment, and state-specific availability. Compounded medications do not undergo the same FDA review process as finished FDA-approved drugs. Pricing, treatment availability, and platform terms should be verified directly through AgelessRx before making any health-related or purchasing decision.

CONTACT: Phone: 650-503-9990
Email: info@agelessrx.com

YolTech Therapeutics Receives FDA Clearance to Initiate Phase 2/3 Study of In Vivo Gene-Editing Therapy YOLT-202 in Alpha-1 Antitrypsin Deficiency (AATD)

YolTech Therapeutics Receives FDA Clearance to Initiate Phase 2/3 Study of In Vivo Gene-Editing Therapy YOLT-202 in Alpha-1 Antitrypsin Deficiency (AATD)




YolTech Therapeutics Receives FDA Clearance to Initiate Phase 2/3 Study of In Vivo Gene-Editing Therapy YOLT-202 in Alpha-1 Antitrypsin Deficiency (AATD)

SHANGHAI–(BUSINESS WIRE)–YolTech Therapeutics, a late clinical-stage biotechnology company developing in vivo gene-editing therapies, today announced that the U.S. Food and Drug Administration (FDA) has approved the Investigational New Drug (IND) application for YOLT-202, the company’s investigational in vivo base-editing therapy for the treatment of Alpha-1 Antitrypsin Deficiency (AATD).

The FDA approval enables the initiation of an open-label, single-dose expansion Phase 2/3 clinical study to evaluate the efficacy and safety of YOLT-202 in adult patients with Alpha-1 Antitrypsin Deficiency (AATD). The study is designed as a multiregional clinical trial (MRCT) to be conducted at clinical sites in the U.S. and other countries.

YOLT-202 is currently being investigated in a first-in-human investigator-initiated trial (IIT) (NCT07193615) designed to evaluate the safety, tolerability, and preliminary efficacy of YOLT-202 in patients with AATD. As of the date of this release, two patients had been enrolled and completed dose. Following administration of YOLT-202, both patients showed rapid, robust and dose-dependent increases in AAT level as early as in Week 1. AAT levels in both patients reached above the protective threshold of 11 μM. Additionally, AAT levels increased to normal range (>20 μM) in the 45 mg dose group. These newly produced AAT proteins were both structurally corrected (M-AAT) and functional, with the proportion of corrected M-AAT increasing to >95% in the 45 mg dose group.

“The FDA clearance, together with the encouraging early clinical data, highlights the transformative potential of YOLT-202 and our in vivo base-editing platform,” stated Yuxuan Wu, M.D., Co-Founder and CEO of YolTech Therapeutics. “We are excited to advance this Phase 2/3 study and bring a potential ‘one and done’ therapy to patients with Alpha-1 Antitrypsin Deficiency.”

About YOLT-202

YOLT-202 is an in vivo gene-editing therapy that corrects PiZ mutation to PiM for the treatment of AATD. Utilizing YolTech’s proprietary adenine base editor, YOLT-202 is engineered to achieve on-target editing with minimal bystander activity. YOLT-202 has previously been granted Orphan Drug Designation (ODD) by the U.S. Food and Drug Administration (FDA).

About Alpha-1 Antitrypsin Deficiency (AATD)

AATD is an inherited, genetic, autosomal co-dominant disorder caused by mutations in the SERPINA1 gene, with the most frequent deficient variants coming from the Z (Glu342Lys) and S alleles (Glu264Val). The presence of Z alleles results in misfolding and polymerization of the AAT, leading to over 95% of severe AATD patients being PIZZ.

About YolTech

Built on HEPDONE™ Novel Editor Platform and non-viral LNP technologies, YolTech Therapeutics is advancing in vivo gene-editing medicines with the potential for a one-time treatment that provides lifelong benefit. The company’s expanding clinical pipeline addresses genetic, metabolic, cardiovascular, and autoimmune diseases, with early clinical results supporting the potential for durable and transformative outcomes.

Stay informed with the latest from YolTech Therapeutics:

LinkedIn: linkedin.com/company/yoltech-therapeutics
Website: www.yoltx.com

Contacts

company name: YolTech Therapeutics

media contact: Ally Yu

email address: xiaolingyu@yoltx.com

Vanish DrySerum Nanofiber Acne Mask Claims Evaluated: 2026 Consumer Research Report Examining Barrier Repair Technology, Ingredient Research, and What Consumers Should Verify Before Buying

Vanish DrySerum Nanofiber Acne Mask Claims Evaluated: 2026 Consumer Research Report Examining Barrier Repair Technology, Ingredient Research, and What Consumers Should Verify Before Buying




Vanish DrySerum Nanofiber Acne Mask Claims Evaluated: 2026 Consumer Research Report Examining Barrier Repair Technology, Ingredient Research, and What Consumers Should Verify Before Buying

Vanish Skincare’s nanofiber dry-fiber delivery format, barrier repair ingredient research, and published guarantee conditions examined for consumers researching acne mask options in 2026.

Boca Raton, FL, March 13, 2026 (GLOBE NEWSWIRE) — This article contains affiliate links. If a purchase is made through these links, a commission may be earned at no additional cost to the buyer. This article is an informational overview and does not constitute medical, health, or skincare advice. All product details described below are stated as presented by the company and should be verified directly on the official website before any purchasing decision.

In this report, the term “effectiveness” refers strictly to how Vanish DrySerum’s marketing language describes potential outcomes. It does not indicate that the finished product has been independently clinically proven effective for all users, and individual results will vary.

Consumers researching acne treatments in 2026 are increasingly encountering products positioned around skin barrier repair rather than the stripping-based approaches that have defined acne care for decades. The frustration driving that search is familiar: traditional treatments — benzoyl peroxide, retinoids, aggressive salicylic acid protocols — can help address breakouts but may also be associated with burning, peeling, and barrier disruption for some users.

One product generating attention across skincare communities and social platforms is Vanish DrySerum, a nanofiber acne mask marketed by Vanish Skincare. The company positions it around what it describes as a patented DrySerum nanofiber delivery system that, according to the brand, releases active ingredients into the skin while simultaneously supporting barrier repair — an approach the brand contrasts directly with conventional treatment methods.

Vanish DrySerum Nanofiber Acne Mask Claims Evaluated 2026 Consumer Research Report Examining Barrier Repair Technology, Ingredient Research, and What Consumers Should Verify Before Buying

This report examines the claims presented by Vanish Skincare, the ingredient-level research referenced in those claims, and the questions consumers may wish to verify independently before purchasing. Consumers who want to review full product details alongside this report can do so by viewing the current Vanish DrySerum offer on the official Vanish Skincare page.

Individual results vary. Skincare products are not substitutes for professional dermatological evaluation or prescribed treatment. Consult a qualified healthcare provider before beginning any new acne regimen, particularly if you have sensitive skin, rosacea, or an existing skin condition.

What Is Vanish DrySerum

Vanish DrySerum is a topical acne mask sold by Vanish Skincare, a direct-to-consumer skincare brand. The product is available exclusively through the company’s official website and ships within the United States and internationally.

The company describes DrySerum as a nanofiber acne mask designed to differ from traditional spot treatments, creams, toners, and serums through its dry-fiber delivery format. Rather than a wet or gel-based product, DrySerum is a dry fiber sheet that the brand states dissolves on contact with damp skin, releasing active ingredients directly into the skin without the water dilution and preservative load the company associates with standard topical formulas.

According to Vanish Skincare’s published product information, DrySerum is formulated to address what the brand identifies as two primary shortcomings of conventional acne treatment: the skin barrier damage caused by harsh actives, and the limited penetration depth of standard delivery formats. The company states the product is dermatologist-tested, intended for a range of skin types including sensitive and rosacea-prone skin, and designed for daily use without the recovery periods that more aggressive treatment protocols may require.

Vanish Skincare is headquartered at 3358 NW 53rd Cir, Boca Raton, FL 33496. Customer support is available by email at hello@vanishskincare.com and by phone at +1 844 240 5420.

The Nanofiber Delivery Claim: What Vanish DrySerum States vs. What Research Can Evaluate

The central technology claim behind Vanish DrySerum is its patented nanofiber delivery system. According to the brand’s marketing materials, the ultra-thin dry fibers dissolve instantly on damp skin and release pure actives without water or preservatives. The company states this format delivers concentrated ingredients up to 8x deeper than standard creams and 4x deeper than conventional topical products.

Nanofiber technology as a cosmetic and pharmaceutical delivery mechanism is an active area of published research. The general premise underlying the claim — that reducing particle size and eliminating aqueous dilution may increase ingredient penetration through the stratum corneum — has been explored in dermatological research contexts. Published studies on nanofiber scaffolds for wound healing, controlled release, and transdermal delivery have appeared in journals including the Journal of Controlled Release and the International Journal of Pharmaceutics.

That said, the specific penetration depth figures cited in Vanish DrySerum’s marketing materials — 4x and 8x deeper than creams — represent the company’s proprietary claims for its specific patented formulation. These figures are not drawn from published, independent, head-to-head comparison studies involving Vanish DrySerum as a finished product. Consumers should treat these metrics as the brand’s stated performance positioning rather than independently verified measurements in public literature.

The active ingredients themselves — azelaic acid, niacinamide, salicylic acid, and zinc ferment — do have individual-level published research supporting their roles in acne management, barrier function, and sebum regulation. That ingredient-level research is discussed in the sections below. The distinction between ingredient-level evidence and product-level evidence is worth understanding clearly before drawing conclusions about what this finished formula may or may not deliver.

The Skin Barrier Angle: What the Company Claims and What Dermatological Research Supports

Vanish DrySerum’s marketing framework positions a damaged skin barrier as a key driver of recurring acne — specifically arguing that traditional treatments create a cycle of barrier disruption that can make skin more vulnerable to future breakouts.

This framing has meaningful support in published dermatological literature. Research published in the Journal of Investigative Dermatology and the British Journal of Dermatology has documented that acne-prone skin often shows compromised barrier function markers, including increased transepidermal water loss (TEWL) and disrupted microbiome diversity. Multiple studies examining tretinoin, benzoyl peroxide, and salicylic acid have noted that while these actives can be effective at targeting acne lesions, they may also transiently impair barrier integrity for some users — contributing to dryness, sensitivity, and rebound oiliness.

According to the company’s sales page, its testing program found improvements in barrier function markers including TEWL, pH balance, and microbiome diversity within 14 days of DrySerum use. This claim is presented as an outcome of the company’s own clinical testing; it does not appear to reference a published, peer-reviewed, independent study evaluating Vanish DrySerum’s finished formula. Consumers who want to verify these findings independently should contact the manufacturer directly to request study documentation.

The broader concept — that addressing breakouts while simultaneously supporting barrier repair is preferable to a treatment-only approach — is consistent with current evidence-based dermatological thinking. Whether this specific product delivers on that framework at its actual application dosage is a question that only independent clinical testing of the finished formula can definitively answer.

Vanish DrySerum Active Ingredients: What Published Research Supports

According to the brand’s published product information and FAQ section, Vanish DrySerum’s formula includes the following key active ingredients:

Azelaic Acid: Azelaic acid is a well-studied topical ingredient with published research supporting its use in reducing inflammatory and non-inflammatory acne lesions. A 2020 review in the Journal of the American Academy of Dermatology noted that azelaic acid at relevant concentrations demonstrated antibacterial activity against Cutibacterium acnes, helped reduce hyperpigmentation from post-acne marks, and showed a favorable tolerability profile compared to benzoyl peroxide. It is also one of the few acne actives with documented compatibility for sensitive and rosacea-prone skin. The specific concentration used in DrySerum’s formula is not disclosed in publicly available product information.

Niacinamide: Niacinamide (vitamin B3) has been studied for its role in regulating sebum production, reducing inflammation, and supporting ceramide synthesis — a key component of skin barrier repair. A frequently cited study published in the International Journal of Dermatology found that topical niacinamide at 4% concentration produced statistically significant reductions in sebum output and acne lesion counts compared to placebo over an eight-week period. Its inclusion alongside barrier-supportive ingredients aligns with the company’s stated formula rationale.

Salicylic Acid: Salicylic acid is a beta-hydroxy acid with well-established published evidence for comedolytic (pore-clearing) activity. Because it is oil-soluble — unlike alpha-hydroxy acids — it can penetrate into sebaceous follicles to help dissolve the debris that contributes to blackheads and whiteheads. At appropriate concentrations, it is generally well-tolerated in daily-use topical products.

Zinc Ferment: Published research on zinc in acne management includes both topical and oral studies. Topical zinc formulations have demonstrated anti-inflammatory and sebum-regulatory properties in several clinical contexts. Fermented zinc forms are used in cosmetic formulations for enhanced skin compatibility. Independent research on zinc ferment specifically within nanofiber delivery systems is limited in publicly available literature.

Tea Tree Extract: Tea tree (Melaleuca alternifolia) extract has been studied for its antibacterial and anti-inflammatory properties in acne applications. A randomized controlled trial published in the Medical Journal of Australia found that 5% tea tree gel produced comparable results to 5% benzoyl peroxide in reducing acne lesion counts, with fewer reported side effects including dryness and irritation.

These are individual ingredient-level findings. They describe what published research has observed under specific study conditions at disclosed concentrations. They do not evaluate Vanish DrySerum as a finished formula and do not confirm that the concentrations present in DrySerum’s formulation align with those used in the cited research.

Barrier Repair vs. Stripping: How the Two Approaches Compare

To understand what differentiates Vanish DrySerum’s positioning from conventional acne treatment, it helps to understand the distinction between the two approaches at the ingredient level.

Traditional actives (benzoyl peroxide, tretinoin, strong salicylic acid protocols): These ingredients work primarily by targeting acne at the bacterial, comedonal, or cellular turnover level. Published research supports their effectiveness for many users. Commonly documented drawbacks can include initial purging periods, dryness, increased photosensitivity, and reduced tolerability for sensitive skin — effects linked to their potential impact on skin barrier integrity during active use.

Barrier-repair approach (DrySerum’s stated model): By combining antibacterial and exfoliating actives with ingredients that support barrier function — including niacinamide and zinc — the stated goal is to address breakouts without simultaneously compromising the skin’s protective layer. According to the brand’s FAQ, this approach is designed to allow for consistent daily use without the recovery periods that harsher protocols can require.

The brand reports that 96% of surveyed users preferred DrySerum over benzoyl peroxide, retinoids, and other treatments they had previously tried. This figure represents user-reported preference data collected from the brand’s own customer pool — people who chose to try and continue using the product. It is not a random sample of the general acne-treatment-using population and does not represent an independently conducted comparative clinical trial. Consumers should interpret it as a brand-reported feedback metric rather than an independent finding.

What Vanish DrySerum’s Clinical Testing Claims Actually State

The brand’s marketing uses the phrase “Clinically Tested” in connection with several specific outcome figures. Understanding exactly what that language means — and what it doesn’t — helps put those numbers in the right context.

According to the company’s published marketing materials, its clinical testing program found:

  • 0% of participants experienced burning, peeling, or irritation
  • 89% saw significant improvements in under three weeks
  • Improvements in barrier function markers including TEWL, pH balance, and microbiome diversity within 14 days
  • A 45-day usage period as the timeframe referenced in the company’s satisfaction guarantee

“Clinically Tested” indicates that a structured evaluation was conducted by or on behalf of the company. It does not mean the results were published in a peer-reviewed journal, replicated by independent researchers, or held to the same methodology standards required for pharmaceutical drug approval. For cosmetic skincare products, this designation can describe a range of testing frameworks — from large-scale randomized controlled trials to smaller in-house consumer studies.

No publicly accessible, peer-reviewed study independently corroborating these specific claims for Vanish DrySerum’s finished formula appears to be available at this time. Consumers who want to understand the underlying study methodology can request documentation directly from Vanish Skincare’s support team at hello@vanishskincare.com.

Who Might Consider Vanish DrySerum in 2026

Vanish DrySerum May Align Well With People Who:

Have experienced significant side effects from conventional acne treatments: Adults who have dealt with chronic dryness, peeling, or irritation from benzoyl peroxide or retinoid-based protocols may find the barrier-supportive ingredient approach worth evaluating as an alternative.

Prefer a simplified daily routine: The brand describes the application format as a short, single-step process built around cleansing, applying the mask to damp skin, and following with moisturizer. Those looking to reduce product overlap may find the format appealing.

Have sensitive or rosacea-prone skin: The brand specifically addresses this population in its marketing and FAQ content. The company describes DrySerum as dermatologist-tested and formulated for a range of skin types, including sensitive skin. Individuals with diagnosed rosacea should still consult their dermatologist before introducing any new active ingredient product.

Are dealing with recurring inflammatory breakouts: According to the brand’s FAQ, DrySerum is marketed for concerns that may include recurring inflammatory breakouts, including hormonal-looking or deeper blemish patterns. Those managing these concerns alongside the guidance of a dermatologist or healthcare provider may find this an option worth discussing with their provider.

Other Options May Be Preferable For People Who:

Require dermatologist-prescribed treatments: Moderate-to-severe acne, cystic presentations, or acne with significant scarring risk typically benefit from prescription-level care. Over-the-counter topical products, including DrySerum, are not substitutes for a dermatologist’s clinical evaluation and treatment plan.

Need transparent individual ingredient concentrations: DrySerum’s formula does not disclose the exact concentration of each active in its publicly available labeling. Consumers or providers who need specific azelaic acid or salicylic acid percentages for clinical comparison should contact the manufacturer directly.

Are seeking guaranteed outcomes: As with any skincare product, individual responses vary based on skin type, acne presentation, consistency of use, hormonal factors, and other personal variables. The guarantee structure has specific conditions — detailed in the section below — rather than an unconditional refund model.

Questions to Ask Yourself:

  • Have I previously experienced significant irritation or barrier damage from conventional acne treatments?
  • Is my current acne presentation being managed with or without a dermatologist’s guidance?
  • Am I looking to simplify my routine, or do I prefer a layered skincare approach?
  • Do I have any diagnosed skin conditions — such as rosacea, eczema, or contact dermatitis — that warrant provider input before introducing new active ingredients?

Your answers can help clarify whether DrySerum’s approach aligns with your specific situation. A dermatologist is the most reliable resource for matching an acne treatment format to your individual skin health needs.

Vanish DrySerum Pricing and Purchase Structure

According to pricing information published on the company’s official website at the time of this report, Vanish DrySerum is offered through several package configurations. The brand states that all orders ship within 24–48 hours of being placed, with average U.S. delivery times of 3–5 business days. International shipping timelines vary by destination and customs processing.

Pricing, package options, and any current promotional offers are subject to change without notice. Consumers should verify current pricing and availability by viewing the current Vanish DrySerum offer on the official Vanish Skincare page before making a purchasing decision.

Vanish DrySerum Refund Policy and 45-Day Guarantee: What to Know Before Ordering

The company publishes a 45-Day Money-Back Guarantee on its official website. Before ordering, consumers should understand the specific conditions that apply, as this is not an unconditional return policy.

According to Vanish Skincare’s published guarantee terms as of January 2026:

  • The product must have been used for at least 30 days as directed — beginning from the date of receipt — before a refund request qualifies
  • The refund request must be submitted within 45 days of delivery
  • The refund applies to a maximum of one month’s worth of product, capped at $99.99 — additional boxes are not covered
  • Original shipping and handling fees are non-refundable
  • Return shipping costs are the customer’s responsibility and are also non-refundable
  • The company recommends using a trackable shipping method for all returns
  • Once approved, refunds are processed within 14 business days

Refund requests can be initiated by emailing hello@vanishskincare.com with your full name, order number, and reason for the request, or by completing the return request form on the company’s website. The brand notes that if DrySerum did not produce the expected results, its support team is open to discussing technique adjustments before processing a return. Always verify current guarantee terms directly on the official website, as policies may be updated after the date of this publication.

Consumers who want to confirm current pricing alongside the full guarantee terms can do so by viewing the current Vanish DrySerum offer on the official Vanish Skincare page.

Consumer Verification Checklist: What to Confirm Before Ordering

Understand what “Clinically Tested” means. This phrase indicates a structured evaluation was conducted — it does not mean the findings were published in a peer-reviewed journal or independently replicated by outside researchers. If the study methodology matters to your decision, contact the manufacturer directly to request documentation.

Distinguish ingredient research from product research. The actives in DrySerum — azelaic acid, niacinamide, salicylic acid, zinc ferment, and tea tree extract — each have published individual-level evidence. That evidence describes what these compounds have shown under specific study conditions. It does not evaluate Vanish DrySerum as a finished formula or confirm that the concentrations in this product match those used in the cited research.

Read the guarantee conditions before purchasing. The 45-day guarantee includes a 30-day minimum use requirement, a single-box refund cap at $99.99, and non-refundable shipping on both ends. Verify the current terms on the official website before placing your order.

Check for active ingredient compatibility. If you are currently using prescription retinoids, topical antibiotics, or other dermatologist-recommended treatments, go over the full ingredient list with your provider before adding DrySerum. Depending on concentrations and individual skin sensitivity, some actives can interact with existing prescription protocols.

Consult a dermatologist for persistent or severe acne. Over-the-counter topical products are generally appropriate for mild-to-moderate presentations. Cystic acne, nodular acne, or acne with a meaningful scarring risk typically calls for clinical evaluation. A dermatologist can determine whether a barrier-repair OTC approach fits your situation or whether prescription-level intervention is the more appropriate path.

Consumer Questions About Vanish DrySerum

What makes DrySerum different from standard acne spot treatments?

According to the brand, the distinction lies in the nanofiber delivery format and the barrier-repair formulation philosophy. The company describes standard spot treatments and creams as applying actives in an aqueous base that limits how deeply they can penetrate. DrySerum’s dry fiber format, as the brand describes it, dissolves on damp skin without water dilution. Whether that translates to meaningfully different real-world outcomes compared to established alternatives has not been confirmed by independent published research on the finished product.

Is Vanish DrySerum FDA approved?

Vanish DrySerum is a cosmetic skincare product. Cosmetic products — including topical acne masks — do not require FDA pre-market approval. The FDA does regulate cosmetic product safety and labeling requirements, but it does not evaluate cosmetic efficacy claims before products reach market. This is the standard regulatory framework for OTC cosmetic skincare and is not unique to DrySerum.

Will DrySerum work on severe or cystic acne?

According to the brand’s FAQ, DrySerum is marketed for concerns that may include recurring inflammatory breakouts, including hormonal-looking or deeper blemish patterns. That said, severe or cystic acne often requires prescription-level care — oral antibiotics, isotretinoin, or hormonal therapy — that topical OTC products cannot replicate. A dermatologist is the appropriate resource for determining the right treatment path for more serious presentations.

What is the application process?

The brand describes the format as a short routine built around cleansing, applying the mask to damp skin, allowing it to dissolve, and following with a moisturizer. The company positions this as a full routine replacement rather than an add-on step.

How long before results may be noticeable?

According to Vanish Skincare’s FAQ, many users report noticing visible improvements — including reduced breakouts and calmer-looking skin — within about seven days. The brand states that consistent use typically delivers longer-term improvements in clarity, pore appearance, and skin texture within 4–12 weeks. These are the brand’s stated timelines based on its customer feedback. Individual results vary based on skin type, acne severity, consistency of use, and other personal factors, and these timeframes are not guarantees.

Can DrySerum be used alongside other skincare products?

According to the brand’s FAQ, yes — though the company recommends keeping the surrounding routine simple. The suggested approach, per the brand, is to cleanse, apply DrySerum, and follow with a gentle moisturizer. Layering multiple active products may increase the risk of irritation and could undermine the barrier-repair goal the formula is designed around.

Does DrySerum help with acne scars and dark spots?

According to the brand’s FAQ, the azelaic acid and niacinamide in the formula are described as intended to help reduce the appearance of dark spots, hyperpigmentation, and post-acne marks by calming inflammation and supporting skin cell turnover. Azelaic acid has published research supporting a role in post-inflammatory hyperpigmentation; niacinamide has been studied in connection with melanin transfer inhibition. These are ingredient-level findings, and individual outcomes for post-acne discoloration will vary.

Is Vanish DrySerum suitable for sensitive skin?

The brand describes DrySerum as dermatologist-tested and formulated for a range of skin types, including sensitive skin. The company specifically notes it is intended to be gentle enough for rosacea-prone skin as well. That said, individuals with diagnosed skin conditions should consult their dermatologist before introducing any new active ingredient product, regardless of the brand’s stated tolerability positioning.

What happens if I order more than one box?

Per the brand’s published guarantee terms, the refund applies to a maximum of one month’s worth of product, capped at $99.99. Additional boxes ordered beyond the first are not covered under the money-back guarantee. Review the current terms on the official website before placing a multi-box order.

Where is Vanish DrySerum sold?

According to the brand’s published terms, Vanish DrySerum is sold exclusively through the official company website. The terms note that resale through unauthorized channels may affect product integrity or the ability to honor guarantees. Consumers should purchase directly from the official site to protect guarantee eligibility.

Summary of Key Considerations

Vanish DrySerum is a topical nanofiber acne mask the brand markets around a barrier-repair delivery approach that it positions as an alternative to conventional stripping-based acne treatments. The formula includes active ingredients — azelaic acid, niacinamide, salicylic acid, zinc ferment, and tea tree extract — that each have published ingredient-level research supporting roles in acne management and skin barrier support.

The brand’s nanofiber technology claims, specific penetration depth figures, and consumer preference statistics represent the company’s own proprietary testing data and customer feedback. No published, independent, peer-reviewed clinical trial evaluating Vanish DrySerum as a finished formula appears to be publicly available at this time. The “Clinically Tested” designation reflects the company’s own testing program rather than external independent publication.

The 45-day guarantee has specific conditions — including a 30-day minimum use requirement, a single-box refund maximum of $99.99, and non-refundable shipping on both ends — that consumers should review carefully before ordering. The brand’s customer support team is reachable by phone at +1 844 240 5420 and by email at hello@vanishskincare.com.

Consumers who have completed their research and want to confirm current pricing, packaging, and guarantee terms can do so by viewing the current Vanish DrySerum offer on the official Vanish Skincare page.

Contact Information

Company: Vanish Skincare
Address: 3358 NW 53rd Cir, Boca Raton, FL 33496, USA
Email: hello@vanishskincare.com
Phone: +1 844 240 5420

Disclaimers

Content and Consumer Information Disclaimer: This article is an independent informational overview and does not constitute medical, health, skincare, or dietary advice. All product details, ingredient information, pricing, and policy terms described in this article are stated as presented by the company on its publicly available website and product labeling. This content has not been independently audited or verified unless specifically noted. Readers are encouraged to verify all claims directly with the manufacturer and to consult a qualified healthcare or skincare professional before beginning any new topical acne treatment.

Skincare and Cosmetic Product Notice: Vanish DrySerum is a topical cosmetic product. It is not a prescription medication or an FDA-approved drug. The statements made by the manufacturer regarding this product have not been evaluated by the Food and Drug Administration in the context of drug approval. Individual results vary based on skin type, acne severity, consistency of use, lifestyle factors, and other personal variables. Persistent, severe, or worsening acne should be evaluated by a qualified dermatologist or healthcare provider.

Results, Pricing, and Product Variability: All pricing, promotional offers, shipping terms, and refund policies referenced in this article are based on information published on the official product website at the time of writing (March 2026) and may change without notice. The 45-day guarantee is subject to specific eligibility conditions, including a 30-day minimum use requirement, a single-box refund maximum of $99.99, and non-refundable shipping fees. Consumers should verify current terms on the official website before completing any purchase.

FTC Affiliate Disclosure and Publisher Responsibility: This article contains affiliate links. If a product is purchased through these links, a commission may be earned at no additional cost to the buyer. This compensation does not influence the accuracy, neutrality, or integrity of the information presented. The publisher of this article is not responsible for typographical errors, manufacturer changes to the product after publication, or individual consumer outcomes.

CONTACT: Email: hello@vanishskincare.com
Phone: +1 844 240 5420

InflaRx Announces Receipt of Nasdaq Deficiency Notice Regarding Minimum Bid Price Requirement

InflaRx Announces Receipt of Nasdaq Deficiency Notice Regarding Minimum Bid Price Requirement




InflaRx Announces Receipt of Nasdaq Deficiency Notice Regarding Minimum Bid Price Requirement

JENA, Germany, March 13, 2026 (GLOBE NEWSWIRE) — InflaRx N.V. (Nasdaq: IFRX), a biopharmaceutical company pioneering anti-inflammatory therapeutics by targeting the complement system, today announced that it has received a written notice (the “Notice”), dated March 11, 2026, from the Listing Qualifications Department of The Nasdaq Stock Market LLC (“Nasdaq”) indicating that, for the last thirty (30) consecutive business days, the bid price for the Company’s ordinary shares had closed below the minimum $1.00 per share requirement for continued listing on the Nasdaq under Nasdaq Listing Rule 5450(a)(1) (the “Minimum Bid Price Rule”).

In accordance with Nasdaq Listing Rule 5810(c)(3)(A), the Company has been provided an initial period of 180 calendar days, or until September 7, 2026, to regain compliance. If the Company fails to regain compliance with the Minimum Bid Price Rule during this period, the Company may consider applying to transfer its securities from The Nasdaq Global Select Market to The Nasdaq Capital Market, provided that the Company meets the applicable market value of publicly held shares required for continued listing and all other applicable requirements for initial listing on The Nasdaq Capital Market (except for the bid price requirement). Such transfer would provide the Company with an additional 180 calendar days, or until March 8, 2027, to regain compliance. There can be no assurance that the Company would be eligible for the additional 180 calendar day compliance period, if applicable, or that the Nasdaq staff would grant the Company’s request for continued listing.

The Notice has no immediate effect on the listing or trading of the Company’s ordinary shares. The Company intends to monitor the bid price of its common shares and consider available options to regain compliance with the Minimum Bid Price Rule.

About InflaRx N.V.
InflaRx (Nasdaq: IFRX) is a biopharmaceutical company pioneering anti-inflammatory therapeutics by applying its proprietary anti-C5a and anti-C5aR technologies to discover, develop and commercialize highly potent and specific inhibitors of the complement activation factor C5a and its receptor, C5aR. C5a is a powerful inflammatory mediator involved in the progression of a wide variety of inflammatory diseases. InflaRx‘s lead program is izicopan (INF904), an orally administered small molecule inhibitor of C5a-induced signaling via the C5a receptor, which has shown promising PK/PD characteristics as well as therapeutic potential in Phase 1 and Phase 2a clinical studies. The company is developing izicopan for the treatment of several inflammatory diseases, including hidradenitis suppurativa (HS). The Company has also developed vilobelimab, a novel, intravenously delivered, first-in-class, anti-C5a monoclonal antibody that selectively binds to free C5a and has demonstrated disease-modifying clinical activity and tolerability in multiple clinical studies.

InflaRx was founded in 2007, and the group has offices and subsidiaries in Jena and Munich, Germany, as well as Ann Arbor, MI, USA. For further information, please visit www.inflarx.de. InflaRx GmbH (Germany) and InflaRx Pharmaceuticals Inc. (USA) are wholly owned subsidiaries of InflaRx N.V. (together, InflaRx).

Contacts:

InflaRx N.V. MC Services AG
Jan Medina, CFA
Vice President, Head of Investor Relations
Email:IR@inflarx.de
Katja Arnold, Laurie Doyle, Dr. Regina Lutz
Email:inflarx@mc-services.eu
Europe: +49 89-210 2280
U.S.: +1-339-832-0752
   

FORWARD-LOOKING STATEMENTS
This press release contains forward-looking statements. All statements other than statements of historical fact are forward-looking statements, which are often indicated by terms such as “may,” “will,” “should,” “expect,” “plan,” “anticipate,” “could,” “intend,” “target,” “project,” “estimate,” “believe,” “predict,” “potential” or “continue,” among others, statements regarding our compliance with the Minimum Bid Price Rule and listing or trading of our ordinary shares. Forward-looking statements appear in a number of places throughout this release and may include statements regarding our intentions, beliefs, projections, outlook, analyses, current expectations and the risks, uncertainties and other factors described under the headings, “Risk factors” and “Cautionary statement regarding forward looking statements”, in our periodic filings with the SEC. These statements speak only as of the date of this press release and involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Given these risks, uncertainties and other factors, you should not place undue reliance on these forward-looking statements, and we assume no obligation to update these forward-looking statements, even if new information becomes available in the future, except as required by law.

Tevogen Reaffirms Capital Discipline as Lead Investor Maintains Holdings and Company Limits Share Utilization

Tevogen Reaffirms Capital Discipline as Lead Investor Maintains Holdings and Company Limits Share Utilization




Tevogen Reaffirms Capital Discipline as Lead Investor Maintains Holdings and Company Limits Share Utilization

  • Lead investor confirmed his intention to maintain his current shareholdings.
  • Company does not anticipate using more than 1% of our authorized shares, including placement through the ATM, over the next 12 months or until the company becomes cash-flow positive.
  • Approximately only one-fifth of total shares outstanding are in the tradable float when accounting for Tevogen’s lead investor, directors and named executive officers.
  • Company prioritizing long-term stock-based incentive program aligned with company milestones.
  • Board of Directors continues to evaluate the potential declaration of a one-time special cash dividend to shareholders.
  • Company continues to evaluate acquisitions that could generate over $50 million in combined annual revenue.
  • Company exploring avenues to better reflect value of assets.

WARREN, N.J., March 13, 2026 (GLOBE NEWSWIRE) — Tevogen (“Tevogen Bio Holdings Inc.” or “Company”) (Nasdaq: TVGN) today provided a strategic update regarding its approach to capital management and the continued commitment of its foundational stakeholders.

Dr. Manmohan Patel, MD, lead investor in Tevogen, commented, “I continue to have strong conviction in Tevogen’s proprietary ExacTcell™ platform and its potential to deliver meaningful medical innovation. As the Company advances its diversified growth strategy and moves toward operational maturity, I intend to maintain my current shareholdings as a reflection of my long-term confidence in the team, the technology, and the path ahead.”

“Tevogen was built on the principle of delivering affordable medical innovations through a highly capital-efficient business model,” said Dr. Ryan Saadi, Founder and CEO of Tevogen Bio. “Based on our current business plan and growth strategy, we do not anticipate utilizing more than one percent of our total authorized shares, including placement through the ATM, over the next twelve months or until the company becomes cash-flow positive.”

Approximately only one-fifth of total shares outstanding are in the tradable float when accounting for Tevogen’s lead investor, directors and named executive officers.

Consistent with the January 2026 update, Tevogen continues to prioritize a long-term stock-based incentive program that is strictly aligned with company milestones, including revenue and clinical targets, rather than traditional time-based vesting.

Board of Directors continues to evaluate the potential declaration of a one-time special cash dividend to shareholders, contingent upon the achievement of specified financial milestones to be determined at a future date, which could include revenue and earnings targets.

The Company continues to evaluate acquisitions that complement its immunotherapy and artificial intelligence platforms. If completed, these businesses would operate as Tevogen subsidiaries and could generate over $50 million in combined annual revenue.

GAAP accounting may not fully reflect the value of Company assets. Tevogen’s intellectual property, proprietary platforms, AI technologies, strategic partnerships, discovery lab, and manufacturing facility under development remain central to long-term value creation. Independent valuations in 2022 estimated the company at over $4 billion prior to going public. The company is exploring ways to better reflect these assets.

About Tevogen

Tevogen is a socially integrated healthcare enterprise built on the principles of affordability, efficiency, and scientific rigor. The company leverages artificial intelligence and precision T cell therapy platforms, a patient-first and cost-disciplined operating model, and engagements with global technology leaders to support the development of advanced, life-saving therapies across multiple therapeutic areas and scalable solutions for the broader healthcare system.

Tevogen Bio, the company’s lead initiative, has completed a proof-of-concept clinical trial demonstrating the potential of its single-HLA-restricted, genetically unmodified allogeneic T cells. Tevogen Bio’s pipeline spans virology, oncology, and neurology, with programs built on the company’s proprietary ExacTcell™ platform.

Tevogen.AI is designed to transform drug development by accelerating target detection, helping reduce failure rates, and supporting optimized clinical trial design through proprietary predictive technologies. The platform utilizes cloud and data services from leading technology providers, including Microsoft and Databricks, to advance its long-term ambition to predict the proteome for any given protein–HLA combination, enabling rapid and cost-efficient therapeutic discovery.

Tevogen is exploring future strategic initiatives that may include domestic generics, biosimilars, medical devices, and innovative insurance solutions for healthcare providers. Together, these programs reflect Tevogen’s mission to advance sustainable innovation and broaden patient access through a faster, more efficient, and more equitable healthcare model.

Forward Looking Statements

This press release contains certain forward-looking statements, including without limitation statements relating to: the potential transactions and the potential benefits of the transactions; Tevogen’s plans for its research and manufacturing capabilities; expectations regarding future growth; expectations regarding the healthcare and biopharmaceutical industries; and Tevogen’s development of, the potential benefits of, and patient access to its product candidates for the treatment of infectious diseases and cancer. Forward-looking statements can sometimes be identified by words such as “may,” “could,” “would,” “expect,” “anticipate,” “possible,” “potential,” “goal,” “opportunity,” “project,” “believe,” “future,” and similar words and expressions or their opposites. These statements are based on management’s expectations, assumptions, estimates, projections and beliefs as of the date of this press release and are subject to a number of factors that involve known and unknown risks, delays, uncertainties and other factors not under the company’s control that may cause actual results, performance or achievements of the company to be materially different from the results, performance or other expectations expressed or implied by these forward-looking statements.

Factors that could cause actual results, performance, or achievements to differ from those expressed or implied by forward-looking statements include, but are not limited to: risks inherent in diligence and negotiation of the proposed transactions; the risk that the transactions may not be consummated on favorable terms or at all; the risk that the expected benefits of the transactions may not be realized on a timely basis or at all; changes in the markets in which Tevogen competes, including with respect to its competitive landscape, technology evolution, or regulatory changes; changes in domestic and global general economic conditions; the risk that Tevogen may not be able to execute its growth strategies or may experience difficulties in managing its growth and expanding operations; the risk that Tevogen may not be able to develop and maintain effective internal controls; the failure to achieve Tevogen’s commercialization and development plans and identify and realize additional opportunities, which may be affected by, among other things, competition, the ability of Tevogen to grow and manage growth economically and hire and retain key employees; the risk that Tevogen may fail to keep pace with rapid technological developments to provide new and innovative products and services or make substantial investments in unsuccessful new products and services; that Tevogen will need to raise additional capital to fully realize its business plans; risks related to the ability to develop, license or acquire new therapeutics; the risk of regulatory lawsuits or proceedings relating to Tevogen’s business; uncertainties inherent in the execution, cost, and completion of preclinical studies and clinical trials; risks related to regulatory review, approval and commercial development; risks associated with intellectual property protection; Tevogen’s limited operating history; and those factors discussed or incorporated by reference in Tevogen’s most recent Annual Report on Form 10-K and subsequent filings with the SEC.

You should not place undue reliance on forward-looking statements, which speak only as of the date they are made. Tevogen undertakes no obligation to update any forward-looking statements, except as required by applicable law.

Contact

Tevogen Bio Communications
T: 1 877 TEVOGEN, Ext 701
Communications@Tevogen.com

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/62b98121-9ad5-4ec7-8275-9541ff0332ae

Novartis Cosentyx® receives FDA approval for pediatric patients aged 12+ with moderate to severe hidradenitis suppurativa

Novartis Cosentyx® receives FDA approval for pediatric patients aged 12+ with moderate to severe hidradenitis suppurativa




Novartis Cosentyx® receives FDA approval for pediatric patients aged 12+ with moderate to severe hidradenitis suppurativa

  • Cosentyx is the only IL-17A inhibitor approved for this population, and the first differentiated mechanism in nearly a decade1-3 

  • HS often emerges around puberty, underscoring importance of early diagnosis and intervention with biologics to help reduce long-term disease burden4-6 

  • Approval marks fourth pediatric indication for Cosentyx, reinforcing its robust safety and efficacy profile1 

Basel, March 13, 2026 – Novartis announced today that Cosentyx® (secukinumab) received US Food and Drug Administration (FDA) approval for treating pediatric patients 12 years and older with moderate to severe hidradenitis suppurativa (HS), making it the only IL-17A inhibitor for this population1. The approval of a distinct biologic option for pediatric patients living with HS allows treatment to be tailored to the individual and establishes Cosentyx as a meaningful addition to the treatment landscape1-13.

“Hidradenitis suppurativa (HS) often begins in adolescence and can cause irreversible scarring and disabilities,” said Alexa B. Kimball, MD, MPH, lead investigator of the SUNSHINE and SUNRISE clinical trials in adult HS patients, President and CEO of Harvard Medical Faculty Physicians at Beth Israel Deaconess Medical Center, Boston, and Professor of Dermatology at Harvard Medical School. “The approval of Cosentyx represents an important advancement for younger HS patients who have had limited treatment options.” 

HS is a chronic, systemic inflammatory skin disease that causes recurring boil-like lesions, which can rupture into painful wounds and lead to scarring7. HS affects as many as 1 in 100 people worldwide and often begins around puberty7.  More than half of patients develop symptoms during adolescence, highlighting the importance of early intervention5,6.

“Hidradenitis suppurativa (HS) affects far more than skin; it impacts confidence, emotional well-being and relationships during a formative period for many pediatric patients,” said Brindley Brooks, Founder & CEO, HS Connect. “For families watching their children struggle, this FDA approval brings hope for earlier intervention.” 

The distinct IL-17A mechanism provides physicians with a differentiated therapeutic option to help manage this challenging condition in younger patients, with dosing tailored to patient weight1.  The use of Cosentyx in patients aged 12+ with moderate to severe HS weighing 30 kg or more is supported by well-controlled adult studies and pharmacokinetic modeling extrapolated from adult HS and psoriasis clinical trials, as well as pediatric clinical trial data from other approved indications1. The approval is also supported by dosing analysis, which predicted that weight-based dosing of Cosentyx in pediatric patients can provide similar exposure to adult HS patients1.

“With more than a decade of real-world experience across multiple autoimmune diseases, Cosentyx is a well-established treatment option that many physicians trust,” said Victor Bultó, President, Novartis US. “Yet for young people living with moderate to severe hidradenitis suppurativa (HS), treatment options have remained limited for far too long. Expanding Cosentyx to this population addresses a critical gap in care and underscores our focus on advancing solutions where we can make the greatest impact on outcomes.”   

About Cosentyx® (secukinumab)
Cosentyx is a fully human biologic that directly inhibits interleukin-17A, an important cytokine involved in the inflammation underlying multiple immune-mediated inflammatory diseases. It is approved for use in adults with hidradenitis suppurativa (HS), psoriatic arthritis (PsA), moderate to severe plaque psoriasis (PsO), ankylosing spondylitis (AS), and non-radiographic axial spondyloarthritis (nr-axSpA)8-10, as well as in pediatric patients with HS, PsO, enthesitis-related arthritis (ERA), and juvenile psoriatic arthritis (JPsA)11,12. Cosentyx is supported by robust evidence and more than 10 years of real-world data demonstrating its long-term safety and sustained efficacy13-18. Since its launch in 2015, it has been used to treat more than 1.8 million patients worldwide and is now approved in over 100 countries13.

About hidradenitis suppurativa (HS) 
HS is a chronic, systemic, progressive and often painful inflammatory skin disease6,19. It causes recurring boil-like abscesses that can burst, creating open wounds, often in the most intimate parts of the body, which may result in irreversible scarring6,20. It can take up to 10 years on average to get a correct diagnosis, and may affect approximately 1 in 100 people globally6,21. HS impacts patients’ quality of life more than any other skin disease, and people living with HS often experience comorbidities such as obesity, diabetes, arthritis and depression20,22, 23.

Disclaimer
This press release contains forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements can generally be identified by words such as “potential,” “can,” “will,” “plan,” “may,” “could,” “would,” “expect,” “anticipate,” “look forward,” “believe,” “committed,” “investigational,” “pipeline,” “launch,” or similar terms, or by express or implied discussions regarding potential marketing approvals, new indications or labeling for the investigational or approved products described in this press release, or regarding potential future revenues from such products. You should not place undue reliance on these statements. Such forward-looking statements are based on our current beliefs and expectations regarding future events, and are subject to significant known and unknown risks and uncertainties. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those set forth in the forward-looking statements. There can be no guarantee that the investigational or approved products described in this press release will be submitted or approved for sale or for any additional indications or labeling in any market, or at any particular time. Nor can there be any guarantee that such products will be commercially successful in the future. In particular, our expectations regarding such products could be affected by, among other things, the uncertainties inherent in research and development, including clinical trial results and additional analysis of existing clinical data; regulatory actions or delays or government regulation generally; global trends toward health care cost containment, including government, payor and general public pricing and reimbursement pressures and requirements for increased pricing transparency; our ability to obtain or maintain proprietary intellectual property protection; the particular prescribing preferences of physicians and patients; general political, economic and business conditions, including the effects of and efforts to mitigate pandemic diseases; safety, quality, data integrity or manufacturing issues; potential or actual data security and data privacy breaches, or disruptions of our information technology systems, and other risks and factors referred to in Novartis AG’s current Form 20-F on file with the US Securities and Exchange Commission. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise.

About Novartis
Novartis is an innovative medicines company. Every day, we work to reimagine medicine to improve and extend people’s lives so that patients, healthcare professionals and societies are empowered in the face of serious disease. Our medicines reach more than 300 million people worldwide.

Reimagine medicine with us: Visit us at https://www.novartis.com and connect with us on LinkedIn, Facebook, X/Twitter and Instagram.

References

  1. Cosentyx. Prescribing information. Novartis Pharmaceuticals Corp.  
  2. Humira. Prescribing Information. AbbVie Inc. 
  3. Celltrion, Inc. FDA approves expanded pediatric indications for YUFLYMA® (adalimumabaaty) and unbranded adalimumabaaty in the United States. Press release. Celltrion; October 17, 2025. Available from: https://www.celltrion.com/en-us/company/media-center/press-release/4207. [Last accessed: February 5, 2026]. 
  4. Ingram JR. The epidemiology of hidradenitis suppurativa. Br J Dermatol. 2020;183(6):990-998. doi:10.1111/bjd.19435 
  5. Molina-Leyva A, Cuenca-Barrales C. Adolescent-onset hidradenitis suppurativa: prevalence, risk factors and disease features. Dermatology. 2019;235(1):45-50. doi:10.1159/000493465 
  6. Hallock KK, Mizerak MR, Dempsey A, Maczuga S, Kirby JS. Differences between children and adults with hidradenitis suppurativa. JAMA Dermatol. 2021;157(9):1095-1101. doi:10.1001/jamadermatol.2021.2865 
  7. MedLine Plus. Hidradenitis suppurativa [online]. Available from: https://medlineplus.gov/genetics/condition/hidradenitis-suppurativa/ [Last accessed: January 2026]. 
  8. Novartis Europharm Limited. Cosentyx® (secukinumab): Summary of Product Characteristics. Available at: https://www.ema.europa.eu/en/documents/product-information/cosentyx-epar-product-information_en.pdf [Last accessed: February 2026]. 
  9. Girolomoni G, Mrowietz U and Paul C. Psoriasis: rationale for targeting interleukin-17. Br J Dermatol 2012; 167: 717-724. 
  10. Novartis Cosentyx shows clinically meaningful symptom improvements in patients with hidradenitis suppurativa. [Press release]. Available at: https://www.novartis.com/news/media-releases/novartis-cosentyx-shows-clinically-meaningful-symptom-improvements-patients-hidradenitis-suppurativa-pivotal-phase-iii-trials [Last accessed: February 2026]. 
  11. Novartis Cosentyx receives FDA approval for the treatment of children and adolescents with enthesitis-related arthritis and psoriatic arthritis. [Press release]. Available at: https://www.novartis.com/news/media-releases/novartis-cosentyx-receives-fda-approval-treatment-children-and-adolescents-enthesitis-related-arthritis-and-psoriatic-arthritis [Last accessed: February 2026]. 
  12. Novartis Cosentyx receives positive CHMP opinion for expanded use in childhood arthritic conditions. [Press release]. Available at: https://www.novartis.com/news/media-releases/novartis-cosentyx-secukinumab-receives-positive-chmp-opinion-expanded-use-childhood-arthritic-conditions [Last accessed: February 2026]. 
  13. Data on file. Cosentyx WW LTD patients Q1’25. 
  14. Uta Kiltz et al. Secukinumab Retention and Effectiveness in Patients with PsA and Radiographic Axial Spondyloarthritis: 5-year Final Results of a Prospective Real-world Study. Abstract no:2344. ACR 2024 [Link
  15. Ippoliti et al. Long-Term Real-World Safety Profile of Secukinumab Assessed Through a 9-Year Experience in Patients Affected by Psoriasis, Psoriatic Arthritis and Ankylosing Spondylitis: Results From a Multicentric Retrospective Study. Dermatologic Therapy. 2025. Article Number: 9618241 [Link
  16. Mease PJ, Kavanaugh A, Reimold A, Tahir H, Rech J, Hall S, Geusens P, Pascale P, Delicha EM, Pricop L, Mpofu S. “Secukinumab Provides Sustained Improvements in the Signs and Symptoms in Psoriatic Arthritis: Final 5Year Efficacy and Safety Results from a Phase 3 Trial”. ACR/ARHP 2020 Annual Meeting Abstract. Presented in ACR Open Rheumatology (2020); CONCL00511 (Secukinumab Provides Sustained Improvements in the Signs and Symptoms of Psoriatic Arthritis: Final 5-year Results from the Phase 3 FUTURE 1 Study – PubMed) 
  17. McInnes IB, Mease PJ, Kivitz AJ, Nash P, Rahman P, Rech J, Conaghan PG, Kirkham B, Navarra S, Belsare AD, Delicha EM, Pricop L, Mpofu S; FUTURE 2 Study Group. “Longterm efficacy and safety of secukinumab in patients with psoriatic arthritis: 5year (endofstudy) results from the phase III FUTURE 2 study.” Lancet Rheumatology. 2020; 2(4): e227–e235. (Long-term efficacy and safety of secukinumab in patients with psoriatic arthritis: 5-year (end-of-study) results from the phase 3 FUTURE 2 study) 
  18. Bissonnette R, Luger T, Thaçi D, Toth D, Lacombe A, Xia S, Mazur R, Patekar M, Charef P, Milutinovic M, Leonardi C, Mrowietz U.Secukinumab demonstrates high sustained efficacy and a favourable safety profile in patients with moderate-to-severe psoriasis through 5 years of treatment (SCULPTURE Extension Study). J Eur Acad Dermatol Venereol. 2018 Sep;32(9):1507–1514. (Secukinumab demonstrates high sustained efficacy and a favourable safety profile in patients with moderate-to-severe psoriasis through 5 years of treatment (SCULPTURE Extension Study) – PubMed) 
  19. Garg A, Naik HB, Alavi A, et al. Real-World Findings on the Characteristics and Treatment Exposures of Patients with Hidradenitis Suppurativa from US Claims Data. Dermatol Ther (Heidelb). 2023 Feb;13(2):581-594. doi: 10.1007/s13555-022-00872-1. 
  20. Sabat R, Jemec GBE, Matusiak L, et al. Hidradenitis Suppurativa. Nat Rev Dis Primers. 2020;6 18. doi: 10.1038/s41572-020-0149-1. 
  21. Kokolakis G, Wolk K, Schneider-Burrus S, et al. Delayed Diagnosis of Hidradenitis Suppurativa and Its Effect on Patients and Healthcare System. Dermatology. 2020;236(5):421-430. doi: 10.1159/000508787 
  22. Mac Mahon J, Kirthi S, Byrne N, et al. An Update on Health-Related Quality of Life and Patient-Reported Outcomes in Hidradenitis Suppurativa. Patient Relat Outcome Meas. 2020;11:21-26. doi: 10.2147/PROM.S174299. 
  23. Montero-Vílchez T, Sánchez-Díaz M, Martínez-López A, et al. Quality of Life in Patients with Skin Disease and Their Cohabitants. In: Jasneth M, Sage A, Medhane C, Eds. Health-Related Quality of Life. Rijeka: IntechOpen; 2021: Ch. 5. 

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E-mail: media.relations@novartis.com

 

 
Novartis Investor Relations
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Sigyn Therapeutics Issues Shareholder Update Regarding Potential Merger and Asset Sale Initiatives

Sigyn Therapeutics, Inc.

/ Key word(s): Manufacturing

Sigyn Therapeutics Issues Shareholder Update Regarding Potential Merger and Asset Sale Initiatives

13.03.2026 / 17:08 CET/CEST

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


Dear Shareholders and Interested Parties,

Prior to our formation of Sigyn Therapeutics, I was the founder of Aethlon Medical and oversaw the development of the Aethlon HemopurifierTM from concept to becoming the first therapy to receive multiple FDA “Breakthrough Device” designations and first medical device cleared by FDA to treat a pandemic virus. TIME magazine named the HemopurifierTM a “Top 25 Invention” and a “Top Eleven Medical Breakthrough.” During my tenure, Aethlon became Nasdaq-listed and had a peak-market value of approximately $200 million.

At Sigyn Therapeutics, we have developed CardioDialysisTM to address relevant therapeutic targets underlying a wide range of life-threatening disease conditions.  These include clinically significant drivers of cardiovascular disease (leading cause of death worldwide), as well as relevant pathogenic and inflammatory molecules that fuel sepsis, the leading cause of in-hospital mortality. Based on invitro study results, CardioDialysisTM also offers a potential therapeutic solution to address traumatic brain injury (TBI) and other disorders whose recovery would benefit from a reduction of systemic inflammation.  Our TBI indication has recently emerged to become asset whose value we hope to leverage through a strategic transaction.

Our opportunity to treat cardiovascular disease is straightforward, yet among the most significant opportunities in healthcare. Lipoprotein apheresis devices that reduce the presence of cholesterol-transporting lipoproteins in the bloodstream reduce heart attacks, strokes and other major adverse cardiovascular events (MACE) to a far greater extent than cardiovascular disease drugs. However, the availability of lipoprotein apheresis is limited to fewer than 60 specialized apheresis centers in the United States. Whereas CardioDialysisTM targets cholesterol-transporting lipoproteins plus inflammatory molecules and is designed for use on dialysis machines already located at more than 7,500 dialysis clinics in the United States alone.

At present, there is no approved therapy to address sepsis. The leading treatment candidate is the PMX hemoadsorption device, which removes endotoxin from the bloodstream.  The PMX device has been advanced through groundbreaking clinical studies conducted by industry colleagues at Spectral Medical, a Toronto Stock Exchange company whose market value is approximately $300 million. Should the PMX device receive FDA market clearance, it may become notable that CardioDialysis has been validated to reduce the presence of sepsis inducing bacterial toxins (including endotoxin) and a broad-spectrum of inflammatory mediators from human blood plasma.  In the meantime, I encourage you to follow Spectral Medical.

While I am proud of our advancements at Sigyn Therapeutics, it was not our intent be an OTC traded company at this point in our endeavors.  In my previous company, we became public through a merger with an established OTC company and subsequently were able to conduct a successful uplist to Nasdaq financing.

At Sigyn Therapeutics, we also became public through a merger with an established OTC company yet failed to execute on an uplist to Nasdaq financing. The financing was a firm commitment offering led by a FINRA member broker-dealer and was supported by the same lead investor and advisory team that got us across the goal at my previous company.  However, it was not anticipated that Nasdaq would request to review and approve our investors prior to obtaining an effective registration statement from SEC. For those not familiar with the process, this was a real catch-22 as investors are not supposed to be solicited prior to a registration statement being deemed effective by SEC. Inversely, SEC wanted to know if we had contingent listing approval from Nasdaq prior to deeming our registration statement effective.  Recognizing the futility of our efforts, we eventually withdraw the registration statement underlying our uplist to Nasdaq financing.

While share price and exchange does not impact the ability of our therapies to address life-threatening disease conditions, it has clearly impacted our ability capitalize our endeavors without harming shareholder value. I encourage you to review my January 15th shareholder update which highlights our strategies to navigate forward with reduced shareholder dilution. Included among these is the sale of certain assets and a potential merger with a Nasdaq listed company at risk of not meeting the forthcoming $5 million minimum market value of listed securities (MVLS) requirement that will soon be necessary for continued listing on Nasdaq.

https://www.sigyntherapeutics.com/investors/news-events/press-releases/detail/118/sigyn-therapeutics-issues-shareholder-update-highlighting

In closing, I thank you for taking the time to read my update. For those who have inquired, we have 2,330,042 shares outstanding as of March 11, 2026. If you have questions or comments, I can be reached at jj@sigyntherapeutics.com.

Sincerely, Jim

About Sigyn Therapeutics™

Sigyn Therapeutics is developing dialysis-like therapies to address cardiovascular disease and cancer. The Company’s therapeutic candidates are designed to improve and extend the quality of patient lives, and their successful clinical advancement offers to provide strategic value to the dialysis and biopharmaceutical industry.

Sigyn CardioDialysis™ is a first-in-industry medical device to treat cardiovascular disease, the leading cause of death globally. CardioDialysis™ aims to reduce the circulating presence of inflammatory molecules that fuel cardiovascular disease progression while simultaneously lowing levels of cholesterol-transporting lipoproteins that contribute to heart attacks, strokes, and other Major Adverse Cardiovascular Events (MACE). Based on its broad-spectrum mechanism, CardioDialysis™ offers to reduce the incidence of MACE by overcoming the inherent limitations of single-target drugs.

The Company’s development pipeline is comprised of ImmunePrep™ to optimize the delivery of immunotherapeutic antibodies to treat cancer; ChemoPrep™ to enhance the targeted delivery of chemotherapy; and ChemoPure™ to reduce the toxicity of chemotherapy.

To learn more about Sigyn Therapeutics, visit: www.SigynTherapeutics.com

CONTACT:
Sigyn Therapeutics, Inc.
Jim Joyce
Inventor CEO
Email: jj@SigynTherapeutics.com

Cautionary Note Regarding Forward-Looking Statements

This information in this press release contains forward-looking statements of Sigyn Therapeutics, Inc. (“Sigyn”) that involve substantial risks and uncertainties. All statements contained in this summary are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 that involve risks and uncertainties. Statements containing words such as “may,” “believe,” “anticipate,” “expect,” “intend,” “plan,” “project,” “will,” “projections,” “estimate,” “potentially” or similar expressions constitute forward-looking statements. Such forward-looking statements are subject to significant risks and uncertainties, and actual results may differ materially from the results anticipated in the forward-looking statements. These forward-looking statements are based upon Sigyn’s current expectations and involve assumptions that may never materialize or may prove to be incorrect. Factors that may contribute to such differences may include, without limitation, the Company’s ability to clinically advance Sigyn Therapy in human studies required for market clearance, the Company’s ability to manufacture Sigyn Therapy, the Company’s ability to raise capital resources, and other potential risks. The foregoing list of risks and uncertainties is illustrative but is not exhaustive. Additional factors that could cause results to differ materially from those anticipated in forward-looking statements can be found under the caption “Risk Factors” in the Company’s Annual Report on Form 10-K, and in the Company’s other filings with the Securities and Exchange Commission, including its quarterly Reports on Form 10-Q. All forward-looking statements contained in this report speak only as of the date on which they were made. Except as may be required by law, the Company does not intend, nor does it undertake any duty, to update this information to reflect future events or circumstances.

News Source: Sigyn Therapeutics, Inc.


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2291428  13.03.2026 CET/CEST

Ipsen – February 2026 – Monthly information relative to the total number of voting rights and shares composing the share capital

Ipsen – February 2026 – Monthly information relative to the total number of voting rights and shares composing the share capital




Ipsen – February 2026 – Monthly information relative to the total number of voting rights and shares composing the share capital

Monthly information relative to the total number of voting rights
and shares composing the share capital

(in accordance with Article L.233-8 II of the French Commercial Code and
Article 223-16 of the General Regulation of the Autorité des Marchés Financiers)

Market: Euronext Paris
ISIN Code: FR 0010259150
LEI: 549300M6SGDPB4Z94P11

Date Total number of shares composing the share capital Total number of voting rights (1)
28 February 2026

 

83,814,526

 

Gross total* of voting rights: 131,963,662
Net total** of voting rights: 130,555,356

(1) Existence of a statutory clause imposing an obligation to declare threshold crossing complementary to the one relative to the legal thresholds (Article 10).

* Gross total = total number of voting rights attached to the total number of shares, including the number of shares which benefit of double voting rights and the number of treasury shares. The « Gross total » is used as a basis for the calculation of threshold crossings.9** Net total = total number of voting rights attached to the total number of shares – shares without voting rights.

Attachment

Ipsen – February 2026 – Monthly information relative to the total number of voting rights and shares composing the share capital

Ipsen – February 2026 – Monthly information relative to the total number of voting rights and shares composing the share capital




Ipsen – February 2026 – Monthly information relative to the total number of voting rights and shares composing the share capital

Monthly information relative to the total number of voting rights
and shares composing the share capital

(in accordance with Article L.233-8 II of the French Commercial Code and
Article 223-16 of the General Regulation of the Autorité des Marchés Financiers)

Market: Euronext Paris
ISIN Code: FR 0010259150
LEI: 549300M6SGDPB4Z94P11

Date Total number of shares composing the share capital Total number of voting rights (1)
28 February 2026

 

83,814,526

 

Gross total* of voting rights: 131,963,662
Net total** of voting rights: 130,555,356

(1) Existence of a statutory clause imposing an obligation to declare threshold crossing complementary to the one relative to the legal thresholds (Article 10).

* Gross total = total number of voting rights attached to the total number of shares, including the number of shares which benefit of double voting rights and the number of treasury shares. The « Gross total » is used as a basis for the calculation of threshold crossings.9** Net total = total number of voting rights attached to the total number of shares – shares without voting rights.

Attachment