Tecan presents 2025 results and provides details on program to reignite profitable growth

Tecan presents 2025 results and provides details on program to reignite profitable growth




Tecan presents 2025 results and provides details on program to reignite profitable growth

Ad hoc announcement pursuant to Article 53 of the SIX Exchange Regulation Listing Rules

Tecan presents 2025 results and provides details on program to reignite profitable growth

Financial results for the full year 2025 – Summary

  • Sales of CHF 882.5 million (2024: CHF 934.3 million), down 1.6% in local currencies for the year, with second-half sales growth of 0.4%
  • Order entry increased by 3.8% in local currencies for the full year and by 8.6% in the second half
  • Adjusted EBITDA of CHF 142.1 million (2024: CHF 164.4 million), adjusted EBITDA margin of 16.1% (2024: 17.6%), impacted by adverse foreign exchange effects and tariffs, partly offset by cost-reduction measures and underlying improvements
  • Net profit impacted by non-cash impairment charges of CHF 139.5 million resulting in a reported net loss of CHF 110.7 million (2024: net profit of CHF 67.7 million)
  • Strong operating cash flow of CHF 138.0 million (2024: CHF 148.5 million),
    cash conversion increased to 118% of reported EBITDA (2024: 100%)
  • Proposal for an unchanged dividend of CHF 3.00 per share

Outlook

  • Outlook for 2026
    • Sales expected to increase in the low single-digit percentage range in local currencies, with the relevant market anticipated to remain broadly flat
    • Adjusted EBITDA margin forecast at 15.5-16.5% of sales, reflecting a -110 basis points headwind from FX and tariffs
    • This margin expectation includes an underlying profitability improvement of 50-150 basis points from the transformation program
  • Medium-term outlook maintained
    • Ambition to achieve sales of CHF 1 billion and a 20% adjusted EBITDA margin by 2028, supported by the ongoing transformation program contributing 200-300 basis points

Männedorf, Switzerland, March 16, 2026 – The Tecan Group (SIX Swiss Exchange: TECN) today announced its audited financial results for 2025, reporting a return to sales growth and strong order entry in the second half of the year. Tecan also initiated its short-term financial outlook for 2026 and reaffirmed its medium-term outlook. Later today, the company will host a Capital Markets Update, providing further details on the key drivers supporting its medium-term growth and profitability ambitions.

Tecan CEO Monica Manotas commented: «Our 2025 performance does not reflect Tecan’s potential. We are acting decisively to change that. Our core is intact, and our balance sheet is strong. Through our transformation program, built on portfolio optimization, commercial excellence, and operational excellence, we are focused on returning to profitable growth now, while positioning our company for what is next and beyond.

While the return to growth in our industry is gradual, the forces shaping its future, AI integration, automation, scientific complexity, economic pressure, are powerful and durable. We expect them to drive significant growth in laboratory automation over the coming decade, and we intend to outgrow the market by leading its AI- and data-driven future.

To achieve that, we have launched “Rewired”, a transformation program to future-proof Tecan and excel at both innovation and execution. Technology leadership and the ability to translate it into profitable growth are decisive, for customers and shareholders alike. We will pursue this with financial discipline, rigorous capital allocation, and the strategic focus needed to realize Tecan’s long-term potential.»

Financial results full-year and second half of 2025

Order entry and sales
Order entry for the Group reached CHF 900.9 million for full-year 2025 (2024: CHF 903.6 million), declining by 0.3% in Swiss francs but growing by 3.8% in local currencies. The book-to-bill ratio was above 1 in both business segments. In the second half, order entry grew by 8.6% in local currencies and by 2.6% in Swiss francs.

Group sales for 2025 decreased by 1.6% in local currencies and 5.5% in Swiss francs, totalling CHF 882.5 million (2024: CHF 934.3 million). In the second half of the year, Tecan returned to moderate sales growth, with sales increasing by 0.4% in local currencies. Sales declined by 5.2% in Swiss francs to CHF 443.0 million (2024: CHF 467.1 million).
These sales results were previously communicated in a trading statement on January 9, 2026.

Profitability and Cash Flow
Adjusted EBITDA1 (operating profit before depreciation and amortization) was CHF 142.1 million, down from CHF 164.4 million in 2024. The adjusted EBITDA margin decreased to 16.1% of sales (2024: 17.6%). Margins were significantly impacted by adverse foreign exchange effects (-130 basis points) and tariffs (-70 basis points), partly offset by underlying improvements (+50 basis points). Excluding the combined 200 basis point headwind from foreign exchange effects and tariffs, the adjusted EBITDA margin was 18.1%, in line with the outlook communicated on March 12, 2025. Reported EBITDA was CHF 117.1 million, compared to CHF 148.0 million in the prior year, corresponding to reported margins of 13.3% and 15.8%, respectively.

Net profit was impacted by non-cash impairment charges of CHF 139.5 million from the strategic restructuring of less profitable or loss-making product lines in the Partnering Business. Tecan will leverage synergies between its design and development capabilities and Paramit’s manufacturing capabilities, discontinuing dedicated design functions acquired in 2021. As a result of the impairment charges, the company reported a net loss of CHF 110.7 million (2024: net profit of CHF 67.7 million). In addition to a lower operating profit, net profit was further weighed down by a reduced financial result, mainly reflecting negative foreign exchange effects and the translation of US dollar-denominated assets into Swiss francs. Reported basic earnings per share were CHF -8.74 (2024: CHF 5.30). Adjusted net profit2 amounted to CHF 87.0 million (2024: CHF 103.1 million), with adjusted earnings per share2 of CHF 6.87 (2024: CHF 8.08).

Cash flow from operating activities was CHF 138.0 million, compared to CHF 148.5 million in 2024. Cash conversion improved to 118% of reported EBITDA (2024: 100%). Thanks to solid cash flow management, Tecan’s net liquidity position (cash and cash equivalents plus short-term time deposits, less bank liabilities, loans, and the outstanding bond) increased to CHF 160.8 million as of December 31, 2025, up from CHF 153.7 million on December 31, 2024.
Through its share buyback program, from August 2025 to December 31, 2025, Tecan purchased own shares with a value of CHF 24.8 million. The program allows for the repurchase of registered shares with a value of up to CHF 120 million.

Information by business segment

Life Sciences Business (end-customer business)
Sales in the Life Sciences Business reached CHF 377.1 million (2024: CHF 397.0 million), representing a decrease of 1.0% in local currencies and 5.0% in Swiss francs. In the second half, sales declined by 3.2% in local currencies. During 2025, demand for instruments in Academia & Government was significantly impacted by budget uncertainty and volatile public funding, particularly in the US and China. Biopharma sales were slightly below the prior year in local currencies, with order entry picking up significantly in the second half. Diagnostic accounts continued to see solid sales and order growth in local currencies throughout the year.
Order entry in the Life Sciences Business increased in the low single-digit percentage range in local currencies for the full year, with an acceleration in the second half. The book-to-bill ratio remained above 1 in 2025.

Reported EBIT in the Life Sciences Business segment (earnings before interest and taxes) was CHF 25.7 million (2024: CHF 39.5 million), with the reported operating profit margin decreasing to 6.7% of sales (2024: 9.8%). The segment absorbed the majority of the negative impact from foreign exchange rates and tariffs. In addition, as part of the portfolio optimization, Tecan decided to exit selected activities at Tecan Genomics, resulting in a CHF 5.3 million asset write-off. Cost control measures partially offset these negative effects. Adjusted EBITDA3 for the segment was CHF 63.4 million (2024: CHF 79.1 million), reflecting an adjusted EBITDA margin of 16.5% of sales (2024: 19.6%).

Partnering Business (OEM business)
The Partnering Business recorded sales of CHF 505.4 million (2024: CHF 537.3 million), representing a decrease of 2.0% in local currencies and 5.9% in Swiss francs. In the second half, sales increased by 3.3% in local currencies.
Overall weak demand for life science instrumentation negatively impacted sales of Cavro OEM components and Paramit CDMO manufacturing services. In contrast, strength in diagnostics drove solid growth in local currencies for in-vitro diagnostics systems in the Synergence product line.
Order entry in the Partnering Business grew at a mid-single-digit rate in local currencies for the full year. As expected, order entry accelerated significantly in the second half, with growth in the low double-digit percentage range. The book-to-bill ratio was also above 1 for this segment in 2025.

Reported EBIT in the Partnering Business amounted to a loss of CHF 103.6 million (2024: profit of CHF 46.6 million), primarily due to the non-cash impairment charge of CHF 139.5 million from the strategic restructuring of less profitable or loss-making product lines. Adjusted EBITDA3 for the segment was CHF 89.7 million (2024: CHF 91.1 million), reflecting an adjusted EBITDA margin of 17.7% of sales (2024: 16.9%). The adjusted EBITDA margin increased, mainly due to a positive product mix and strong cost control, which outweighed the adverse effects of foreign exchange and tariffs.

Proposals to the Annual General Meeting

Based on the solid cash flows for the full year 2025 and as an expression of the confidence in Tecan’s future and of the commitment to shareholder returns, the Board of Directors will propose an unchanged dividend of CHF 3.00 per share at the Annual General Meeting on April 15, 2026. Half of the dividend, i.e., CHF 1.50, will again be paid out from the available capital contribution reserve and is therefore not subject to withholding tax.

In addition to the changes in the Board of Directors announced on December 4, 2025, Guillaume Daniellot will also be proposed as a new independent member of the Board of Directors. Guillaume Daniellot has been serving as CEO of the Straumann Group since January 2020, after previously holding various senior management roles within the company. Earlier in his career, he held positions in hospital product management at Coloplast and B. Braun, and in sales and marketing at Dentsply France. He holds a Bachelor’s degree in physics from the University of Dijon, a Master in marketing from FGE in Tours, and a Master’s in business administration from ESC European School of Management, Paris. Guillaume will complement the Board with his extensive knowledge of the medtech industry and his proven leadership in global healthcare markets.

Outlook

For 2026, Tecan expects end markets to recover gradually. However, a full normalization is not anticipated, and market growth is expected to range from a moderate decline to moderate growth. With anticipated improvements in certain customer segments, but continued uncertainty in others, Tecan is initiating its short-term financial outlook for 2026, expecting sales to increase in the low single-digit percentage range in local currencies.

Foreign exchange rates and the annualized impact from tariffs will continue to weigh on profitability in 2026. Tecan assumes a combined headwind of 110 basis points on the adjusted EBITDA margin from these external factors4. Including these effects, Tecan forecasts an adjusted EBITDA margin – excluding restructuring, acquisition, and integration-related costs – of 15.5% to 16.5% of sales. This forecast also reflects an underlying profitability improvement of 50 to 150 basis points as a result of the ongoing transformation program.

Tecan also reiterates its medium-term outlook, which will be further detailed at today’s Capital Markets Update, including an update on the key drivers supporting this outlook. Tecan expects a continued gradual improvement in end markets, with market growth increasing to a range of 1% to 3% in the years 2027-2028. Tecan’s ambition is to achieve sales of CHF 1 billion⁴ and a 20% adjusted EBITDA margin⁴ by 2028. This will be supported by the ongoing “Rewired” transformation program, which is expected to contribute 200-300 basis points through incremental revenue and efficiencies across operations, commercial, G&A, and R&D.

From 2029 onwards, Tecan assumes a return to normal market conditions, with market growth in the previous range of 3% to 5%. In this environment, Tecan expects to return to average organic growth rates in the mid- to high-single-digit percentage range in local currencies, while continuously improving profitability.

Annual Report and Webcast

The full 2025 Annual Report and the 2025 Sustainability Report were also published today and can be accessed on the company’s website www.tecan.com under Investor Relations.

Tecan will hold an analyst and media conference to discuss the 2025 annual results today at 14:00 (CET) in Zurich. The event will also feature a Capital Markets Update, including an update on the key drivers supporting the company’s medium-term outlook. The presentation will be relayed by live audio webcast, which interested parties can access at www.tecan.com. A link to the webcast will be provided immediately prior to the event. A replay of the webcast will be available after the presentation on www.tecan.com for a period of 12 months.

The dial-in numbers for the conference call are as follows (Access Code: 127505):
Switzerland: +41 22 518 90 26

UK: +44 20 3936 2999
United States: +1 646 233 4753
Participants should, if possible, dial in 15 minutes before the start of the event.

Key upcoming dates

  • The Annual General Meeting of Tecan’s shareholders will take place on April 15, 2026
  • A Q1 2026 Qualitative Update will be published on May 12, 2026
  • The 2026 Interim Report will be published on August 11, 2026
  • A Q3 2026 Qualitative Update will be published on November 5, 2026

1 The adjusted operating profit before depreciation and amortization excludes restructuring costs as well as acquisition- and integration-related costs (+CHF 25.0 million)

2 The calculation of adjusted net profit and adjusted earnings per share excludes restructuring costs, acquisition- and integration-related costs (CHF 25.0 million), accumulated amortization of acquired intangible assets (CHF 23.3 million), and one-off, non-cash impairment charges of CHF 139.5 million. They were calculated using the reported Group tax rate of 9.9%.

3 The adjusted operating profit before depreciation and amortization for the Life Sciences Business segment excludes restructuring costs as well as acquisition- and integration-related costs (+CHF 8.1 million). The adjusted operating profit before depreciation and amortization for the Partnering Business segment excludes restructuring costs as well as acquisition- and integration-related costs (+CHF 14.4 million).

4 Assumes tariff rates in effect as of December 31, 2025. Any changes to tariff rates may impact the outlook. Profitability expectations for 2026 and for the medium-term sales and adjusted EBITDA margin outlook are based on an average exchange rate forecast of one euro equaling CHF 0.92 and one US dollar equaling CHF 0.80.

About Tecan
Tecan (www.tecan.com) improves people’s lives and health by empowering customers to scale healthcare innovation globally from life science to the clinic. Tecan is a pioneer and global leader in laboratory automation. As an original equipment manufacturer (OEM), Tecan is also a leader in developing and manufacturing OEM instruments, components and medical devices that are then distributed by partner companies. Founded in Switzerland in 1980, the company has 3,000 employees, with manufacturing, research and development sites in Europe, North America and Asia, and maintains a sales and service network in over 70 countries. In 2025, Tecan generated sales of CHF 883 million (USD 1,063 million; EUR 939 million). Registered shares of Tecan Group are traded on the SIX Swiss Exchange (TECN; ISIN CH0012100191).

For further information:

Tecan Group
Martin Brändle
Senior Vice President, Corporate Communications & IR
Tel. +41 (0) 44 922 84 30
Fax +41 (0) 44 922 88 89
investor@tecan.com
www.tecan.com

Attachment

InnoCare Announces First Healthy Volunteer Dosed in Clinical Trial of Novel VAV1 Degrader ICP-538 in China

InnoCare Announces First Healthy Volunteer Dosed in Clinical Trial of Novel VAV1 Degrader ICP-538 in China




InnoCare Announces First Healthy Volunteer Dosed in Clinical Trial of Novel VAV1 Degrader ICP-538 in China

BEIJING, March 15, 2026 (GLOBE NEWSWIRE) — InnoCare Pharma (HKEX: 09969; SSE: 688428), a leading biopharmaceutical company focusing on the treatment of cancer and autoimmune diseases, announced today that the first healthy volunteer has been dosed in a clinical trial of ICP-538, a VAV1-directed molecular glue degrader (MGD), in China. This is the first VAV1 degrader approved to enter clinical trials in China and the second globally.

ICP-538 is a novel, potent, highly selective, orally administered molecular glue degrader targeting VAV1, a key protein downstream of T-cell and B-cell receptors. ICP-538 induces rapid and efficient degradation of VAV1 protein in a dose-dependent manner by selectively mediating the formation of a ternary complex between the CRBN E3 ubiquitin ligase and the VAV1 protein. ICP-538 will be developed for the treatment of autoimmune diseases, such as inflammatory bowel disease, systemic lupus erythematosus, and multiple sclerosis. Currently, there are no approved VAV1-targeted therapies globally.

Degradation of VAV1 can effectively inhibit T-cell proliferation, differentiation, activation, and cytokine release, as well as B-cell activation and cytokine release, thereby exerting anti-inflammatory and immunomodulatory effects and alleviating autoimmune and inflammatory pathological processes. Preclinical studies have shown that ICP-538 induces deep degradation of VAV1, leading to a significant reduction in cytokines associated with immune-mediated diseases, with no detectable effects on other proteins.

Dr. Jasmine Cui, the Co-founder, Chairwoman, and CEO of InnoCare, said, “We are committed to developing innovative drugs in the field of autoimmune diseases. As a novel therapy, the VAV1 molecular glue degrader offers three major advantages: high target selectivity, mediation of multiple mechanisms of action, and high efficacy. We are pleased to see that we have rapidly advanced clinical development, and we believe that ICP-538 will become a better treatment option for patients with autoimmune diseases.”

About InnoCare

InnoCare is a commercial stage biopharmaceutical company committed to discovering, developing, and commercializing first-in-class and/or best-in-class drugs for the treatment of cancers and autoimmune diseases with unmet medical needs in China and worldwide. InnoCare has branches in Beijing, Nanjing, Shanghai, Guangzhou, Hong Kong, and the United States.

InnoCare Forward-Looking Statements

This report contains the disclosure of some forward-looking statements. Except for statements of facts, all other statements can be regarded as forward-looking statements, that is, about our or our management’s intentions, plans, beliefs, or expectations that will or may occur in the future. Such statements are assumptions and estimates made by our management based on its experience and knowledge of historical trends, current conditions, expected future development and other related factors. This forward-looking statement does not guarantee future performance, and actual results, development and business decisions may not match the expectations of the forward-looking statement. Our forward-looking statements are also subject to a large number of risks and uncertainties, which may affect our short-term and long-term performance.

Contact
 
Media Investors
Chunhua Lu  
86-10-66609879 86-10-66609999
chunhua.lu@innocarepharma.com ir@innocarepharma.com

Pittsburgh Aesthetics Rebrands as Avere Beauty, Expanding Med Spa Services in Mars, Pennsylvania and Surrounding Areas

Pittsburgh Aesthetics Rebrands as Avere Beauty, Expanding Med Spa Services in Mars, Pennsylvania and Surrounding Areas




Pittsburgh Aesthetics Rebrands as Avere Beauty, Expanding Med Spa Services in Mars, Pennsylvania and Surrounding Areas

Transition brings enhanced patient experience and Botox, lip filler, and other med spa treatments

Avere Beauty Logo

Avere Beauty Logo

PITTSBURGH, March 15, 2026 (GLOBE NEWSWIRE) —  Pittsburgh Aesthetics, a physician-led medical aesthetics practice in Mars, Pennsylvania, announced today that it will officially operate under the Avere Beauty brand beginning March 16, 2026. The rebrand unifies the practice under a single identity, offering a consistent, high-quality patient experience while expanding access to advanced med spa services across the Pittsburgh region.

The transition reflects Avere Beauty’s commitment to patient-centered care, ensuring that individuals seeking aesthetic treatments continue to receive the same personalized attention while benefiting from a broader range of services and locations.

What Patients Can Expect:

  • Same care team & location: The Mars office will continue to operate at 179 Scharberry Ln, providing the same experience and care patients know and trust.
  • Expanded med spa services: Patients can continue to access a full suite of services, including Botox, lip filler, biostimulators, PDO threads, facials, Hydrafacials, laser treatments, and weight loss programs. Laser tattoo removal and weight loss services will be available Mid-April
  • Brand updates: Over the coming weeks, patients will notice updated signage, digital platforms, and communications reflecting the Avere Beauty brand.
  • Scheduling continuity: Current appointments will proceed as planned, with new booking details shared via email, text, and the website.
  • Expanded access across locations: In addition to Mars, Avere Beauty operates in Lawrenceville (3453 Butler Street, Pittsburgh, PA 15201), Export/Murrysville (5100 Old William Penn Hwy, Export, PA 15632), and Blawnox (307 Freeport Road, Pittsburgh, PA 15238). These locations offer increased appointment availability and access to the practice’s full med spa offerings.

Avere Beauty Foyer

Avere Beauty Foyer

Founder’s Vision

Alyssa Luciano, RN, an ICU nurse with over fifteen years of experience, founded Avere Beauty to create a med spa that blends professional expertise with a welcoming and educational environment. “Our mission is to provide aesthetic treatments that empower patients and enhance confidence,” said Luciano. Her approach emphasizes natural aesthetics, transparency, and individualized care. The Mars location now offers advanced treatments, including Botox lip filler, Sculptra, and multiple lasers – helping patients achieve natural-looking results tailored to their goals.

Driving Growth

Frank Udavcak, Chief Operations Officer, leads Avere Beauty’s expansion and marketing strategy. With a background in content creation, pharmaceutical branding, and storytelling, Udavcak has guided the practice’s growth and helped bring its physician-led services to more communities in the Pittsburgh area.

This rebrand and expansion aim to strengthen the patient experience, offering more appointment availability and new med spa services.

For more information or to book an appointment, visit Avere Beauty online.

About Avere Beauty

Avere Beauty is a med spa based in Pittsburgh, Pennsylvania, dedicated to providing personalized aesthetic treatments in a comfortable, educational environment. Founded by Alyssa Luciano, RN, the practice offers a full range of services including Botox, lip filler, facials, Hydrafacials, laser treatments, PDO threads, and weight loss programs. With multiple locations across the Pittsburgh region, Avere Beauty combines professional expertise with a patient-centered approach to deliver natural-looking, high-quality results.

Media Contact:
Sophie Brinkman
Avere Beauty
sophie@averebeauty.com
https://www.averebeauty.com/

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/b128c7a3-6481-4b96-8f9f-2efb6540cf54

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/89ffce74-3bea-4619-8603-628af8b99de4

Telix Resubmits NDA to U.S. FDA for TLX101-Px (Pixclara®) Brain Cancer Imaging Candidate

Telix Resubmits NDA to U.S. FDA for TLX101-Px (Pixclara®) Brain Cancer Imaging Candidate




Telix Resubmits NDA to U.S. FDA for TLX101-Px (Pixclara®) Brain Cancer Imaging Candidate

MELBOURNE, Australia and INDIANAPOLIS, March 16, 2026 (GLOBE NEWSWIRE) — Telix Pharmaceuticals Limited (ASX: TLX, NASDAQ: TLX, “Telix”) today announces the resubmission of a New Drug Application (NDA) to the United States (U.S.) Food and Drug Administration (FDA) for TLX101-Px, (Pixclara®1, Floretyrosine F 18 or 18F-FET), an investigational PET2 imaging agent for the characterization of recurrent or progressive glioma (brain cancer) from treatment related changes in both adult and pediatric patients.

Telix has resubmitted the NDA with the additional data requested by the FDA. The Company believes, based on the Type A meeting and ongoing consultation with the FDA, that the additional data and statistical analysis, along with the primary data set provided in the original submission, appropriately addresses the Complete Response Letter3.

Given the potential to address significant unmet medical need, TLX101-Px has been granted Orphan Drug4 and Fast Track5 designations by the FDA. PET imaging with 18F-FET is already included in international clinical practice guidelines for the imaging of gliomas6, however there is currently no FDA-approved targeted amino acid PET agent for adult and pediatric brain cancer imaging commercially available in the U.S.

Dr. David N. Cade, Telix Group Chief Medical Officer, said, “We appreciate the FDA’s recognition of the critical unmet need to improve the diagnosis and management of glioma, particularly in the post-treatment setting. Our resubmission is supported by an extensive and compelling data set – particularly so for an orphan indication. We are grateful to our global clinical collaborators, who share our commitment to ensuring patients in the U.S. can benefit from this important patient management tool.”

Maggie Haynes, Executive Director, Head for the Cure Foundation, added: “Our community is encouraged by the FDA’s ongoing engagement and guidance to the sponsor and support for the Expanded Access Program for TLX101-Px. We are hopeful of an expedited review, so this important and proven imaging option can become available to those who urgently need it.”

About TLX101-Px

TLX101-Px is a PET imaging agent, which has been granted fast track and orphan drug designations by the FDA as an imaging agent for the characterization of recurrent or progressive glioma from treatment related changes. TLX101-Px targets membrane transport proteins known as LAT1 and LAT27. This enables TLX101-Px to be potentially utilized as a companion diagnostic agent to TLX101-Tx (iodofalan 131I), Telix’s LAT1-targeting glioblastoma (GBM) therapy candidate, currently under investigation in the pivotal IPAX-BrIGHT study8. 

About gliomas in the U.S.

Gliomas are very diffusely infiltrative tumors that affect the surrounding brain tissue. They are the most common form of central nervous system (CNS) neoplasm that originates from glial cells, accounting for approximately 30% of all brain and CNS tumors and 80% of all malignant brain tumors9. In the U.S., there are six cases of gliomas diagnosed per 100,000 people every year10. GBM is a high-grade glioma and the most common and aggressive form of primary brain cancer, with approximately 22,000 new cases diagnosed annually in the U.S.11. The mainstay of treatment for GBM comprises surgical resection, followed by combined radiotherapy and chemotherapy. Despite such treatment, recurrence occurs in almost all patients12, with an expected survival duration of 12-15 months from diagnosis13. 

About Telix Pharmaceuticals Limited

Telix is a global biopharmaceutical company focused on the development and commercialization of therapeutic and diagnostic radiopharmaceuticals and associated medical technologies, with the goal to address significant unmet medical needs in oncology and rare diseases. With international operations in the United States, United Kingdom, Brazil, Canada, Europe (Belgium and Switzerland), and Japan, Telix is headquartered in Melbourne, Australia. Telix is listed on the Australian Securities Exchange (ASX: TLX) and the Nasdaq Global Select Market (NASDAQ: TLX).

Illuccix® (kit for the preparation of gallium-68 (68Ga) gozetotide injection), Telix’s first generation PSMA-PET imaging agent, has been approved in multiple markets globally. Gozellix® (kit for the preparation of gallium-68 (68Ga) gozetotide injection) has been approved by the U.S. FDA14. TLX101-Px and TLX101-Tx have not received marketing authorizations in any jurisdiction.

Visit www.telixpharma.com for further information about Telix, including details of the latest share price, ASX and U.S. Securities and Exchange Commission (SEC) filings, investor and analyst presentations, news releases, event details and other publications that may be of interest. You can also follow Telix on LinkedIn, X and Facebook.

Telix Investor Relations (Global)

Ms. Kyahn Williamson
SVP Investor Relations and Corporate Communications
kyahn.williamson@telixpharma.com

Telix Investor Relations (U.S.)  

Ms. Annie Kasparian  
Director Investor Relations and Corporate Communications  
annie.kasparian@telixpharma.com 

Telix Investor Relations (Australia)

Ms. Charlene Jaw
Associate Director Investor Relations
charlene.jaw@telixpharma.com

Media Contact

Eliza Schleifstein
917.763.8106 (Mobile)
Eliza@schleifsteinpr.com

This announcement has been authorized for release by the Telix Pharmaceuticals Limited Disclosure Committee on behalf of the Board.

Legal Notices

Cautionary Statement Regarding Forward-Looking Statements. 

You should read this announcement together with our risk factors, as disclosed in our most recently filed reports with the Australian Securities Exchange (ASX), U.S. Securities and Exchange Commission (SEC), including our Annual Report on Form 20-F filed with the SEC, or on our website.

The information contained in this announcement is not intended to be an offer for subscription, invitation or recommendation with respect to securities of Telix Pharmaceuticals Limited (Telix) in any jurisdiction, including the United States. The information and opinions contained in this announcement are subject to change without notification.  To the maximum extent permitted by law, Telix disclaims any obligation or undertaking to update or revise any information or opinions contained in this announcement, including any forward-looking statements (as referred to below), whether as a result of new information, future developments, a change in expectations or assumptions, or otherwise. No representation or warranty, express or implied, is made in relation to the accuracy or completeness of the information contained or opinions expressed in the course of this announcement.

This announcement may contain forward-looking statements, including within the meaning of the U.S. Private Securities Litigation Reform Act of 1995, that relate to anticipated future events, financial performance, plans, strategies or business developments. Forward-looking statements can generally be identified by the use of words such as “may”, “expect”, “intend”, “plan”, “estimate”, “anticipate”, “believe”, “outlook”, “forecast” and “guidance”, or the negative of these words or other similar terms or expressions. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance or achievements to differ materially from any future results, levels of activity, performance or achievements expressed or implied by these forward-looking statements. Forward-looking statements are based on Telix’s good-faith assumptions as to the financial, market, regulatory and other risks and considerations that exist and affect Telix’s business and operations in the future and there can be no assurance that any of the assumptions will prove to be correct. In the context of Telix’s business, forward-looking statements may include, but are not limited to, statements about: the initiation, timing, progress, completion and results of Telix’s preclinical and clinical trials, and Telix’s research and development programs; Telix’s ability to advance product candidates into, enroll and successfully complete, clinical studies, including multi-national clinical trials; the timing or likelihood of regulatory filings and approvals for Telix’s product candidates, including the planned NDA resubmission for TLX101-Px and the planned BLA resubmission for TLX250-Px, manufacturing activities and product marketing activities; Telix’s sales, marketing and distribution and manufacturing capabilities and strategies; the commercialization of Telix’s product candidates, if or when they have been approved; Telix’s ability to obtain an adequate supply of raw materials at reasonable costs for its products and product candidates; estimates of Telix’s expenses, future revenues and capital requirements; Telix’s financial performance; developments relating to Telix’s competitors and industry; the anticipated impact of U.S. and foreign tariffs and other macroeconomic conditions on Telix’s business; and the pricing and reimbursement of Telix’s product candidates, if and after they have been approved. Telix’s actual results, performance or achievements may be materially different from those which may be expressed or implied by such statements, and the differences may be adverse. Accordingly, you should not place undue reliance on these forward-looking statements.

Trademarks and Trade Names. All trademarks and trade names referenced in this press release are the property of Telix Pharmaceuticals Limited (Telix) or, where applicable, the property of their respective owners. For convenience, trademarks and trade names may appear without the ® or ™ symbols. Such omissions are not intended to indicate any waiver of rights by Telix or the respective owners. Trademark registration status may vary from country to country. Telix does not intend the use or display of any third-party trademarks or trade names to imply any affiliation with, endorsement by, or sponsorship from those third parties.

©2026 Telix Pharmaceuticals Limited. All rights reserved.

1 Brand name subject to final regulatory approval.
2 Positron emission tomography.
3 Telix ASX disclosure April 28, 2025.
4 Telix ASX disclosure October 6, 2020.
5 Telix ASX disclosure April 16, 2024. Fast Track is a process designed to facilitate the development, and expedite the review of drugs to treat serious conditions and fill an unmet medical need. The purpose is to get important new drugs to the patient earlier. More: https://www.fda.gov/patients/fast-track-breakthrough-therapy-accelerated-approval-priority-review/fast-track
6 Galldiks et al. Lancet Oncol. 2025 (Joint guidelines from the European Association of Nuclear Medicine (EANM), European Association of Neuro-Oncology (EANO), Society of Nuclear Medicine and Molecular Imaging (SNMMI), Response Assessment in Neuro-Oncology (RANO), The European Society for Pediatric Oncology and The Response Assessment in Pediatric Neuro-Oncology for the characterization of recurrence in glioma patients); National Comprehensive Cancer Network® (NCCN) Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Central Nervous System Cancers V1.2025.
7 L-type amino acid transporters 1 and 2.
8 ClinicalTrials.gov ID: NCT07100730.
9 Goodenberger et al. Cancer Genet. 2012.
10 Mesfin et al. StatPearls. 2024.
11 Ostrom 2022, CBTRUS (Central Brain Tumor Registry of the United States) Statistical Report.
12 Park et al. Journal of Clinical Oncology. 2010.
13 Ostrom et al. Neuro Oncol. 2018.
14 Telix ASX disclosure March 21, 2025.

Samsung Bioepis and Epis NexLab Sign Research Collaboration and License Agreement with G2GBIO to Develop Novel Assets Including Long-acting Semaglutide

Samsung Bioepis and Epis NexLab Sign Research Collaboration and License Agreement with G2GBIO to Develop Novel Assets Including Long-acting Semaglutide




Samsung Bioepis and Epis NexLab Sign Research Collaboration and License Agreement with G2GBIO to Develop Novel Assets Including Long-acting Semaglutide

  • Samsung Bioepis to receive exclusive license to develop and commercialize two novel assets including long-acting semaglutide using G2GBIO’s proprietary microsphere technology
  • Epis NexLab, a sister company to Samsung Bioepis under Samsung Epis Holdings, also signs the agreement to collaborate in the development of the long-acting microsphere drug delivery platform

INCHEON, Korea–(BUSINESS WIRE)–#Biosimilar–Samsung Bioepis Co., Ltd. and Epis NexLab Co., Ltd., a sister company to Samsung Bioepis under Samsung Epis Holdings (KRX: 0126Z0), today announced a research collaboration and license agreement with G2GBIO, a company specializing in the development of sustained-release formulations, to develop novel assets based on G2GBIO’s proprietary microsphere technology.


Under the agreement, Samsung Bioepis will be given a full license right for the novel long-acting semaglutide asset, and an option to license another asset from G2GBIO. In addition, Samsung Bioepis will be given the first negotiation rights for the three other novel assets to be determined. Epis NexLab will be responsible for the co-development of the long-acting microsphere drug delivery platform using G2GBIO’s proprietary technology. The details of the financial terms remain confidential.

“This agreement represents an important step in expanding our drug delivery capabilities and pipeline,” said Kyung-Ah Kim, President and Chief Executive Officer, at Samsung Bioepis. “By leveraging G2GBIO’s proprietary microsphere technology and collaborating with Epis NexLab, we look forward to the development of innovative therapies and deliver meaningful treatment options to patients.”

About Samsung Bioepis Co., Ltd.

Established in 2012, Samsung Bioepis is a biopharmaceutical company committed to realizing healthcare that is accessible to everyone. Through innovations in product development and a firm commitment to quality, Samsung Bioepis aims to become the world’s leading biopharmaceutical company. As a wholly owned subsidiary of Samsung Epis Holdings, Samsung Bioepis continues to advance a broad pipeline of biologic candidates that cover a spectrum of therapeutic areas, including immunology, oncology, ophthalmology, hematology, nephrology, endocrinology. For more information, please visit www.samsungbioepis.com and follow us on LinkedIn and X.

Contacts

Media Contact
Yoon Kim, yoon1.kim@samsung.com
Anna Nayun Kim, nayun86.kim@samsung.com

Be Well OC Launches “Red Tape” Campaign Calling for Full Access to Behavioral Health Campuses

Be Well OC Launches “Red Tape” Campaign Calling for Full Access to Behavioral Health Campuses




Be Well OC Launches “Red Tape” Campaign Calling for Full Access to Behavioral Health Campuses

Orange and Irvine beds sit empty while community looks to County to deliver on its word

IRVINE, Calif., March 15, 2026 (GLOBE NEWSWIRE) — Two state-of-the-art behavioral health campuses in Orange County are ready to serve all residents, regardless of insurance type. One remains closed. The other is operating under restrictions that limit who can access care.

This week, Be Well Orange County (Be Well OC) launched its “Red Tape” campaign, a movement calling on the County of Orange to open the Irvine Campus and provide access to all residents, regardless of insurance type at both campuses in Irvine and Orange.

To remove the red tape limiting access to care, Be Well OC launched a Change.org petition for the community to sign, asking the County to deliver on its promises.

“Seven years ago, Orange County said access to behavioral health care was fragmented and out of reach. Be Well OC together with public, private, faith-based, academic, healthcare organizations, and others, took steps to solve that problem, building world-class facilities ready to serve everyone. But today the problem continues, red tape is keeping access limited and in the case of the new Irvine campus, the doors are closed. We need your help to open them,” said Phillip Franks, CEO, Be Well OC.

At the Be Well OC Orange Campus, access to the residential treatment programs is limited to County-approved referrals through their behavioral health programs. Since one must come through the County system, which serves roughly 1/3 of the County population, 2/3 of Orange County residents with employer-sponsored, private insurance or MediCare are unable to access services at the campus. In addition, the County-approved referral list for residential programs at the Orange Campus does not include any Orange County hospitals, despite having invested millions in both campuses

“Two-thirds of the Orange County taxpayers who funded these facilities are denied access based on their insurance type. This is the opposite of the Be Well OC vision the community rallied behind – including the County Board of Supervisors. Why are they going back on their promises?” said Dr. Richard Afable, Chairman of the Board, Be Well OC.

Zero Orange County General Fund (local discretionary tax dollars) were used to build the Be Well campuses:

  • Orange Campus — $40M project
    • Hospitals — $12M
    • CalOptima Health — $11.4M
    • California Mental Health Services Act (MHSA) and California Senate Bill 82 funding — $16.6M
  • Irvine Campus — $114M project
    • State of California funding — $50M
    • Federal funding — $4M
    • American Rescue Plan Act (ARPA) funds — $20M
    • Mental Health Services Act (MHSA) funding — $20M
    • CalOptima Health — $15M
    • Hospitals — $5M

In addition to the limited access to the Orange Campus, the Sobering Center was closed by the Orange County Health Care Agency, without explanation in 2024, and remains closed to date.

“The County continues to try to sow distrust in Be Well through their public comments and legal filings, with the ultimate goal of gaining ownership of millions in real estate assets,” continued Franks. “We won’t be distracted. We look forward to our day in court and remain focused on making the campuses accessible to all.”

According to a recent online survey conducted by independent research firm, Mackenzie, among 403 Orange County, Ca. residents from Jan. 8-13, 2026: (Results are statistically valid at a 95% confidence level with a margin of error of approximately +/-4.9%):

  • 65% of residents either personally sought behavioral health care, or knew someone who did, in the past year.
  • 28% of those who sought help, or knew someone who did in the past year, were unable to access the care they needed.
  • Overall, 66% say expanded behavioral health services are extremely or very urgent.

The Irvine Campus is ready to start serving the community. The County has yet to approve the sublease agreement, though it has been submitted to the County for approval on multiple occasions, preventing Be Well OC from entering into leases with County contracted providers, thus causing delays in opening the campus.

“In my work as a rabbi, a therapist, and a chaplain, I have sat with people at their most vulnerable – in pain, and in desperate need of support. I have watched mental health challenges tear through families and communities without warning and without discrimination, and I have seen firsthand what happens when people cannot access care. The opening of the Irvine Campus to all, and the full accessibility of the Orange Campus are not policy discussions; they are moral imperatives,” said Rabbi Richard Steinberg, congregational rabbi in Irvine and Be Well OC Founding Board Member.

Visit Change.org/CutTheRedTapeOC to sign the petition today and express support for opening the Irvine Campus and expanding access to care for all Orange County residents.

ABOUT BE WELL OC
Be Well OC is a transformative initiative bringing together public, private, academic and faith-based organizations to create a coordinated system of behavioral health care and support for all Orange County residents regardless of ability to pay. The Be Well OC behavioral health system, which includes mental health crisis stabilization and substance use services, features two state-of-the-art mental health and wellness facilities in Orange and Irvine, a mobile response program, and a navigation center for individuals and families. Be Well OC’s movement spans across all of Orange County and a range of needs, from prevention and early intervention to crisis aversion, crisis management, acute care and recovery. For more information visit bewelloc.org.

MEDIA CONTACT
Karena Bibbins
karena@ideahall.com

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/76f5638e-553d-4fcf-a250-63ed1d5df1e6

First Ever Real-World Evidence of Eversense 365 Presented at ATTD Demonstrates Sustained Performance and Positive Impact Throughout One-Year of Wear

First Ever Real-World Evidence of Eversense 365 Presented at ATTD Demonstrates Sustained Performance and Positive Impact Throughout One-Year of Wear




First Ever Real-World Evidence of Eversense 365 Presented at ATTD Demonstrates Sustained Performance and Positive Impact Throughout One-Year of Wear

New data shows positive real-world impact of the world’s first and only one-year CGM, with a full year of strong patient adherence, glucometrics and hypoglycemic outcomes

Eversense 365 delivered comparable adherence and outcomes between the first and second six-month period, indicating high accuracy and performance from a single sensor across an entire year

GERMANTOWN, Md., March 14, 2026 (GLOBE NEWSWIRE) — Senseonics, a medical technology company focused on the development, manufacturing and commercialization of long-term, implantable Continuous Glucose Monitoring (CGM) Systems for people with diabetes, today announces new data from a real-world evidence study which demonstrates the sustained performance and positive impact of Eversense 365 across the full one-year period. These findings were presented during an oral presentation entitled ‘Real-World Evaluation Of The Implantable One Year Eversense 365 CGM System’ at the 19th International Conference on Advanced Technologies & Treatments for Diabetes (ATTD), taking place on March 11-14 in Barcelona, Spain.

“The promise of a year-long CGM has now been demonstrated in the real world,” said Francine Kaufman, M.D., Chief Medical Officer at Senseonics. “Since Eversense 365 was launched in the US, we have consistently heard positive feedback about the system and its impact from both patients and their healthcare providers. Today, we have presented real-world evidence that further validates our belief in this technology and what we are hearing from the diabetes community. The data demonstrate that Eversense 365 can perform exceptionally well and consistently across its entire lifespan, with strong adherence supporting a full year of positive glycemic outcomes with just one sensor.”

Strong adherence and positive outcomes
The study evaluated the first 5,059 real-world Eversense 365 CGM sensors to be used by patients in the US, all with open-loop insulin regimens. The analysis revealed strong patient adherence, glucometrics and hypoglycemic outcomes, demonstrating how Eversense 365 can support effective management of diabetes over a full one-year period with just one implantable CGM sensor.

Patients using Eversense 365 had an average transmitter wear time of 93.8%, with comparable results for the first and second six-month periods, indicating a year of consistent and meaningful system use. This resulted in a mean Glucose Management Indicator (GMI) of 7.14% and a mean Time in Range (TIR) of 66%, demonstrating effective glycemic control. GMI is an established metric that provides an estimated A1C using only CGM data, with a lower value indicating better management and reduced health risks. GMI is often used alongside TIR to provide a more complete picture of glycemic control.

Furthermore, over 75% of users of the implanted, year-long CGM system achieved hypoglycemic targets, reinforcing that Eversense 365 is the most accurate CGM in low glucose ranges1,2,3, where errors can have the greatest impact on patient safety and treatment decisions. The real-world analysis also showed that glucometrics and hypoglycemic outcomes were comparable for both the first six months and second six months of wear

Specific age group benefits
Additionally, analysis by age revealed that Eversense 365 supported positive glucometrics and outcomes across all age groups. However, glycemic outcomes were seen to improve with increasing age, with the >65 year-old population achieving a mean GMI of 6.99% and a mean TIR of over 70%, with over 85% achieving hypoglycemic targets. The trend was also observed with adherence, with over 95% average wear time in those 65 years and older. This suggests that, whilst all age groups can benefit from Eversense 365, there may be particular benefits and positive outcomes in older populations.

Furthermore, the analysis suggested that Eversense 365 could bring specific benefits to young adults (aged 18-25), who typically have poorer glycemic control. Encouragingly, this age group had a mean GMI of 7.3% with a mean wear time over 90%, which again demonstrates strong adherence.

Encouraging early analysis of AID combination
Two weeks after the commercial launch of the twiist™ Automated Insulin Delivery (AID) system with Eversense 365, real-world data was also analyzed from the first ~120 people who had used the combined system for more than seven days. The glucose outcomes were extremely encouraging with a mean GMI of 6.79%, mean TIR of 77% and time in hypoglycemia of 2.7%, all meeting the international consensus targets. twiist is the first AID system to be compatible with Eversense 365 and, whilst still in the early stages, the initial data analysis suggests that this powerful combination is already having a positive clinical impact. Senseonics plans to present a longer-term real-world analysis later this year.

Brian Hansen, Chief Commercial Officer at Senseonics, added: “We are proud to present these data at ATTD, which is always a fantastic opportunity to connect with the diabetes ecosystem and discuss the latest developments in technology and care. The meeting is particularly timely for us this year following the recent CE mark approval and upcoming launch of Eversense 365 in select European markets. We are gaining momentum commercially in the US and look forward to bringing the benefits of this unique, implantable CGM to new patients and geographies.”

Eversense 365 is the world’s first and only one year CGM, which was approved by the United States Food and Drug Administration in September of 2024 and launched across the country in October of the same year. In January 2026, Eversense 365 received European CE Mark approval and Senseonics expects to launch Eversense 365 in Germany, Italy, Spain and Sweden in the coming months.

As the only implantable CGM available, Eversense 365 offers patients a truly differentiated CGM experience, providing one year of exceptionally accurate monitoring with minimal interruptions. Eversense 365’s unique approach allows people to overcome common frustrations and interruptions experienced with traditional, short-term CGMs, so that patients can focus on managing their diabetes and not their CGM.

1 Senseonics. (2026) Eversense 365 Continuous Glucose Monitoring System User Guide. LBL-7702-01-001
2 Abbott. (2024) Freestyle Libre 3 PLUS User Guide ART49385-001
3 Dexcom (2025) G7 15 Day User Guide AW00078-10 MT-00078-10


About Eversense

Eversense 365 is developed by Senseonics and, as the only implantable CGM available, offers patients a truly differentiated CGM experience, providing One Year of exceptionally accurate monitoring with minimal interruptions. It benefits endocrinologists and care teams by offering their patients confidence in decision making, long-term peace of mind and enhanced quality of life with just one CGM. The unique approach also allows people to overcome common frustrations and interruptions experienced with traditional, short-term CGMs, so that patients can focus on managing their diabetes and not their CGM.

The Eversense® Continuous Glucose Monitoring (CGM) Systems are indicated for continually measuring glucose levels for up to 365 days for Eversense® 365 and 180 days for Eversense® E3 in persons with diabetes age 18 and older. The systems are indicated for use to replace fingerstick blood glucose (BG) measurements for diabetes treatment decisions. Fingerstick BG measurements are still required for calibration primarily one time per week after day 14 for Eversense® 365 and one time per day after day 21 for Eversense® E3, and when symptoms do not match CGM information or when taking medications of the tetracycline class. The sensor insertion and removal procedures are performed by a health care provider. The Eversense CGM Systems are prescription devices; patients should talk to their health care provider to learn more. For important safety information, see https://www.eversensediabetes.com/safety-info/.

About Senseonics
Senseonics Holdings, Inc. (“Senseonics”) is a medical technology company focused on the development, manufacturing and commercialization of glucose monitoring products designed to transform lives in the global diabetes community with differentiated, long-term implantable glucose management technology. Senseonics’ CGM system Eversense® 365 and Eversense® E3 include a small sensor inserted completely under the skin that communicates with a smart transmitter worn over the sensor. The glucose data are automatically sent every 5 minutes to a mobile app on the user’s smartphone.

Senseonics Media Contact

Tim Stamper
FTI Consulting
Tim.Stamper@senseonics.com / Eversense365@FTIConsulting.com

Senseonics Investor Contact

Jeremy Feffer
LifeSci Advisors
investors@senseonics.com

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