Picard Medical Announces Up to $50 Million Senior Secured Debt Financing

Picard Medical Announces Up to $50 Million Senior Secured Debt Financing




Picard Medical Announces Up to $50 Million Senior Secured Debt Financing

TUCSON, Ariz., Dec. 24, 2025 (GLOBE NEWSWIRE) — Picard Medical, Inc. (NYSE American: PMI) (“Picard” or the “Company”), parent company of SynCardia Systems LLC, maker of the world’s first total artificial heart approved by both the U.S. FDA and Health Canada, today announced that it has entered into a definitive agreement for a private placement financing of up to $50.0 million aggregate principal amount of senior secured notes due 2028 together with warrants to purchase common stock of the Company. WestPark Capital Inc. served as Sole Placement Agent.

The Company expects to issue an initial $15.0 million principal amount of notes at closing with the option to fund up to an additional $35.0 million principal amount in one or more tranches subject to certain conditions. The notes will be senior secured obligations of the Company.

The Company intends to use the net proceeds for working capital and general corporate purposes.

The securities have not been registered under the Securities Act of 1933 as amended or the securities laws of any other jurisdiction and may not be offered or sold in the United States absent registration or an applicable exemption. This press release does not constitute an offer to sell or the solicitation of an offer to buy any securities.

About Picard Medical and SynCardia

Picard Medical, Inc. is the parent company of SynCardia Systems, LLC (“SynCardia”), the Tucson, Arizona–based leader with the only commercially available total artificial heart technology for patients with end-stage heart failure. SynCardia develops, manufactures, and commercializes the SynCardia Total Artificial Heart (“STAH”), an implantable system that assumes the full functions of a failing or failed human heart. It is the first artificial heart approved by both the FDA and Health Canada, and it remains the only commercially available artificial heart in the United States and Canada. With more than 2,100 implants performed at hospitals across 27 countries, the SynCardia Total Artificial Heart is the most widely used and extensively studied artificial heart in the world. For additional information about Picard Medical, please visit www.picardmedical.com or review the Company’s filings with the U.S. Securities and Exchange Commission at www.sec.gov.

Forward-Looking Statements

This press release includes forward-looking statements that involve risks and uncertainties. Forward-looking statements are statements that are not historical facts. Such forward-looking statements are subject to risks and uncertainties, which could cause actual results to differ from the forward-looking statements. The Company expressly disclaims any obligations or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in the Company’s expectations with respect thereto or any change in events, conditions or circumstances on which any statement is based. Forward-looking statements are subject to numerous conditions, many of which are beyond the control of the Company, including those set forth in the Risk Factors section of the Registration Statement and related prospectus filed in connection with the initial public offering with the SEC. Copies are available on the SEC’s website, http://www.sec.gov.

Contact:

Investors
Eric Ribner
Managing Director
LifeSci Advisors LLC
eric@lifesciadvisors.com

Picard Medical, Inc./SynCardia Systems, LLC
IR@picardmedical.com

General/Media
Brittany Lanza
blanza@syncardia.com

Clearmind Medicine Reflects on a Transformative 2025: Key Clinical Advancements, Expanded Global Reach, and Strengthened Foundation for Future Growth

Clearmind Medicine Reflects on a Transformative 2025: Key Clinical Advancements, Expanded Global Reach, and Strengthened Foundation for Future Growth




Clearmind Medicine Reflects on a Transformative 2025: Key Clinical Advancements, Expanded Global Reach, and Strengthened Foundation for Future Growth

Vancouver, Canada, Dec. 24, 2025 (GLOBE NEWSWIRE) — Clearmind Medicine Inc. (Nasdaq: CMND), (FSE: CWY0) (“Clearmind” or the “Company”), a clinical-stage biotech company focused on the discovery and development of novel neuroplastogen-derived therapeutics to solve major under-treated health problems, today reflected on a year of significant momentum and progress in advancing its lead candidate, CMND-100, for the treatment of Alcohol Use Disorder (AUD).

Throughout 2025, Clearmind achieved critical milestones in its FDA-approved Phase I/IIa clinical trial for CMND-100, a proprietary non-hallucinogenic MEAI-based oral compound designed to address AUD—a condition affecting millions worldwide with limited effective treatment options.

Key 2025 highlights include:

Clinical Trial Progress: Advanced the multinational Phase I/IIa trial with site activations at prestigious institutions, including Yale School of Medicine, Johns Hopkins University School of Medicine, Tel Aviv Sourasky Medical Center, and Hadassah Medical Center. The Company successfully initiated first-in-human dosing, completed treatment and enrollment for the first cohort, and reported positive top-line safety and tolerability results with no serious adverse events. Additionally, the first patients in the Israeli sites were enrolled and successfully dosed. Moreover, Clearmind completed enrollment and dosing for the second cohort, accelerating the path toward further data readouts.

Independent Safety Endorsement: Received unanimous approval from the Data and Safety Monitoring Board (DSMB) to continue the Phase I/IIa clinical trial following an interim review, reinforcing CMND-100’s favorable safety profile.

Global Footprint Expansion: Strengthened intellectual property portfolio and pipeline  of its non-hallucinogenic neuroplastogen patents with multiple international patent filings and publications targeting indications such as weight loss, obesity, metabolic disorders, depression, PTSD, anxiety and binge behaviors.

Dr. Adi Zuloff-Shani, CEO of Clearmind Medicine, commented: “2025 has been a pivotal year for Clearmind as we transitioned into a clinical-stage company, executing on our multinational trial. These achievements underscore our disciplined approach to innovation and our commitment to delivering transformative treatments for addictions and mental health challenges. We are grateful to our dedicated team, clinical partners, investigators, and investors for their unwavering support.”

“Looking ahead to 2026, Clearmind remains focused on advancing its pipeline, generating additional clinical data, and exploring strategic opportunities to maximize shareholder value and patient impact”.

About Clearmind Medicine Inc.

Clearmind is a clinical-stage psychedelic pharmaceutical biotech company focused on the discovery and development of novel psychedelic-derived therapeutics to solve widespread and underserved health problems, including alcohol use disorder. Its primary objective is to research and develop psychedelic-based compounds and attempt to commercialize them as regulated medicines, foods, or supplements.

The Company’s intellectual portfolio currently consists of nineteen patent families, including 31 granted patents. The Company intends to seek additional patents for its compounds whenever warranted and will remain opportunistic regarding the acquisition of additional intellectual property to build its portfolio.

Shares of Clearmind are listed for trading on Nasdaq under the symbol “CMND” and the Frankfurt Stock Exchange under the symbol “CWY0.”

For further information, visit: https://www.clearmindmedicine.com or contact:

Investor Relations
invest@clearmindmedicine.com

Telephone: (604) 260-1566
US: CMND@crescendo-ir.com

General Inquiries
Info@Clearmindmedicine.com
www.Clearmindmedicine.com

Forward-Looking Statements:

This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act and other securities laws. Words such as “expects,” “anticipates,” “intends,” “plans,” “believes,” “seeks,” “estimates” and similar expressions or variations of such words are intended to identify forward-looking statements. For example, the Company is using forward-looking statements when it discusses advancing its lead candidate, CMND-100, for the treatment of Alcohol Use Disorder, its commitment to delivering transformative treatments for addictions and mental health challenges, advancing its pipeline, generating additional clinical data, and exploring strategic opportunities to maximize shareholder value and patient impac . Forward-looking statements are not historical facts, and are based upon management’s current expectations, beliefs and projections, many of which, by their nature, are inherently uncertain. Such expectations, beliefs and projections are expressed in good faith. However, there can be no assurance that management’s expectations, beliefs and projections will be achieved, and actual results may differ materially from what is expressed in or indicated by the forward-looking statements. Forward-looking statements are subject to risks and uncertainties that could cause actual performance or results to differ materially from those expressed in the forward-looking statements. For a more detailed description of the risks and uncertainties affecting the Company, reference is made to the Company’s reports filed from time to time with the Securities and Exchange Commission (“SEC”), including, but not limited to, the risks detailed in the Company’s annual report on Form 20-F for the fiscal year ended October 31, 2024 and subsequent filings with the SEC. Forward-looking statements speak only as of the date the statements are made. The Company assumes no obligation to update forward-looking statements to reflect actual results, subsequent events or circumstances, changes in assumptions or changes in other factors affecting forward-looking information except to the extent required by applicable securities laws. If the Company does update one or more forward-looking statements, no inference should be drawn that the Company will make additional updates with respect thereto or with respect to other forward-looking statements. References and links to websites have been provided as a convenience, and the information contained on such websites is not incorporated by reference into this press release. Clearmind is not responsible for the contents of third-party websites.

S&P Global Ratings Upgrades Teva to ‘BB+’ Amid Strong Execution of Pivot to Growth Strategy; Moody’s Ratings Agency Revises Outlook to Positive

S&P Global Ratings Upgrades Teva to ‘BB+’ Amid Strong Execution of Pivot to Growth Strategy; Moody’s Ratings Agency Revises Outlook to Positive




S&P Global Ratings Upgrades Teva to ‘BB+’ Amid Strong Execution of Pivot to Growth Strategy; Moody’s Ratings Agency Revises Outlook to Positive

  • The two updates underscore Teva’s strong execution of its Pivot to Growth strategy and commitment to financial discipline.
  • Moody’s affirmed Teva’s B1a rating and revised Teva’s outlook to positive from stable
  • S&P upgraded Teva to BB+ from BB, with a stable outlook

TEL AVIV, Israel, Dec. 24, 2025 (GLOBE NEWSWIRE) — Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) today announced that S&P Global Ratings (“S&P”) has upgraded Teva’s long-term issuer credit rating to ‘BB+’ from ‘BB’, with a stable outlook, and that Moody’s Ratings Agency (“Moody’s”) affirmed Teva’s B1a rating and revised Teva’s outlook to positive from stable. These upgrades mark another significant milestone in Teva’s journey toward achieving investment-grade status.

The upgrades are underpinned by Teva’s consistent deleveraging trajectory, with S&P noting that adjusted leverage declined to 4.4x as of September 30, 2025, and is expected to fall below 4.25x in the coming quarters, meeting the threshold for the higher rating. The ratings agency also highlighted Teva’s financial discipline, business strength and liquidity profile, returning to revenue growth after five years of declines, driven by robust performance in branded medicines and stabilization in generics.

Moody’s cited Teva’s continued improvement in operating performance and disciplined financial policies focused on debt reduction. The agency highlighted strong momentum in Teva’s branded franchises and upcoming product launches across both branded and biosimilar portfolios, which are expected to offset headwinds in the generics segment. Moody’s also noted Teva’s robust liquidity position, supporting its ability to manage upcoming debt maturities. Moody’s stated that these factors, combined with expectations for leverage to decline toward 3.5x within 12–18 months, underpin the positive outlook and potential for an upgrade.

Eli Kalif, Teva’s Chief Financial Officer, commented: “This upgrade is a powerful testament to our strategic vision and disciplined execution, especially coming at the heels of multiple upgrades in recent months. By driving our Pivot to Growth strategy, prioritizing robust cash flow management, and rigorously allocating capital, we have demonstrated unwavering commitment to deleveraging and sustainable business growth. These results clearly show how our focused strategy is delivering tangible value for Teva and positioning us for continued success.”

About Teva
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) is transforming into a leading innovative biopharmaceutical company, enabled by a world-class generics business. For over 120 years, Teva’s commitment to bettering health has never wavered. From innovating in the fields of neuroscience and immunology to providing complex generic medicines, biosimilars and pharmacy brands worldwide, Teva is dedicated to addressing patients’ needs, now and in the future. At Teva, We Are All In For Better Health. To learn more about how, visit www.tevapharm.com.

Teva Cautionary Note Regarding Forward Looking Statements

In addition to historical information, this press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements regarding our financial guidance, which are based on management’s current beliefs and expectations and are subject to substantial risks and uncertainties, both known and unknown, that could cause our future results, performance or achievements to differ significantly from that expressed or implied by such forward-looking statements. These forward-looking statements include statements concerning our plans, strategies, objectives, future performance and financial and operating targets, and any other information that is not historical information. You can identify these forward-looking statements by the use of words such as “should,” “expect,” “anticipate,” “estimate,” “target,” “may,” “project,” “guidance,” “intend,” “plan,” “believe” and other words and terms of similar meaning and expression in connection with any discussion of future operating or financial performance. Important factors that could cause or contribute to such differences include risks relating to: our ability to successfully compete in the marketplace, including: that we are substantially dependent on our generic products; our ability to develop and commercialize additional pharmaceutical products; competition for our innovative medicines; our ability to achieve expected results from investments in our product pipeline; our ability to successfully execute our Pivot to Growth strategy, including to expand our innovative and biosimilar medicines pipeline and profitably commercialize the innovative medicines and biosimilar portfolio, whether organically or through business development, to sustain and focus our portfolio of generic medicines, and to execute on our organizational transformation and to achieve expected cost savings; and the effectiveness of our patents and other measures to protect our intellectual property rights; our significant indebtedness, which may limit our ability to incur additional indebtedness, engage in additional transactions or make new investments; our business and operations in general; compliance, regulatory and litigation matters; other financial and economic risks; and other factors discussed in this document, in our Quarterly Report on Form 10-Q for the third quarter of 2025 and in our Annual Report on Form 10-K for the year ended December 31, 2024, including in the sections captioned “Risk Factors” and “Forward-looking Statements.” Forward-looking statements speak only as of the date on which they are made, and we assume no obligation to update or revise any forward-looking statements or other information contained herein, whether as a result of new information, future events or otherwise. You are cautioned not to put undue reliance on these forward-looking statements.

Teva Media Inquiries                     TevaCommunicationsNorthAmerica@tevapharm.com 
Teva Investor Relations Inquiries  TevaIR@Tevapharm.com

PharmAla Issues Audited Year End 2025 and Unaudited Q1 Fiscal 2026 Financial Statements

PharmAla Issues Audited Year End 2025 and Unaudited Q1 Fiscal 2026 Financial Statements




PharmAla Issues Audited Year End 2025 and Unaudited Q1 Fiscal 2026 Financial Statements

TORONTO, Dec. 24, 2025 (GLOBE NEWSWIRE) — PharmAla Biotech Holdings Inc. (“PharmAla” or the “Company”) (CSE: MDMA) (OTC: MDXXF), a biotechnology company focused on the research, development, and manufacturing of LaNeo™ MDMA and novel derivatives of MDMA (MDXX class molecules), is pleased to have publicly filed its financial results for the periods ended August 31, 2025 and November 30th, respectively. All figures are reported in Canadian dollars. The Company’s full set of Audited Financial Statements for the 2025 fiscal year, as well as its unaudited condensed interim consolidated financial statements for the first quarter of its 2026 fiscal year, and accompanying management’s discussion and analysis can be accessed by visiting the Company’s website at www.PharmAla.ca and its profile page on SEDAR+ at www.sedarplus.ca.

“Commencing in late 2025 and continuing into Q1 2026 we have taken major steps towards the development of our novel molecules and look to continue this momentum throughout the remainder of fiscal 2026 with the goal of commencing our Phase 2a/b clinical trial in Australia,” said Nick Kadysh, CEO, PharmAla Biotech. “While we have been prioritizing our development, we have continued to see great traction in demand for our LaNeo™ MDMA, which has continued to grow our pipeline of clinical trial sales. With the approval of reimbursement for medical treatments using LaNeo MDMA in Australia, both by private medical insurers and by the Australian Department of Veterans Affairs (“DVA”), we believe that this trend will only continue.”

Financial Highlights:

  • Customer deposits have continued to grow consistently:
    • Year End 2025 – an increase of $150k offset by recognized revenue of $83k, resulting in $276k compared to $209k as at August 31, 2025 and 2024, respectively.
    • Q1 2026 – increase of $225k, offset by recognized revenue of $68k, resulting in $433k compared to $276k as at November 30, 2025 and August 31, 2025, respectively.
    • These deposits, generally being 50% of the total contract value, can be recognized along with the remaining revenue when the related product is shipped, which for many customers requires the issuance of their clinical trial and/or import permits from relevant regulatory bodies.

“We have filed our short-form prospectus, secured a lending partner in Australia and have grown our clinical trial revenue pipeline and related customer deposits, all of which will help us to fund our clinical trial and development work,” said Will Avery, CFO, PharmAla Biotech. “With these pieces in play we are excited for the growth we anticipate for PharmAla in the year ahead.”

About PharmAla

PharmAla Biotech Holdings Inc. (CSE: MDMA) (OTCQB: MDXXF) is a biotechnology company focused on the research, development, and manufacturing of MDXX class molecules, including MDMA. PharmAla was founded with a dual focus: alleviating the global backlog of generic, clinical-grade MDMA to enable clinical trials as well as commercial sales in selected jurisdictions, and to develop novel drugs in the same class. PharmAla is the only company currently provisioning clinical-grade MDMA for patient treatments outside of clinical trials. PharmAla’s research and development unit has completed proof-of-concept research into several IP families, including ALA-002, its lead drug candidate. PharmAla is a “regulatory first” organization, formed under the principle that true success in the psychedelics industry will only be achieved through excellent relationships with regulators.

For more information, please contact:
Nicholas Kadysh
Chief Executive Officer
PharmAla Biotech Holdings Inc.
Email: press@PharmAla.ca
Phone: 1-855-444-6362
Website: www.PharmAla.ca

Neither the CSE nor its Regulation Services Provider have reviewed or accept responsibility for the adequacy or accuracy of this release.

Cautionary Note Regarding Forward-Looking Statements

This press release contains “forward-looking statements” within the meaning of applicable securities laws. All statements contained herein that are not clearly historical in nature may constitute forward-looking statements. Generally, such forward-looking information or forward-looking statements can be identified by the use of forward-looking terminology such as “plans”, “strategy”, “expects” or “does not expect”, “intends”, “continues”, “anticipates” or “does not anticipate”, or “believes”, or variations of such words and phrases or may contain statements that certain actions, events or results “will be taken”, “will launch” or “will be launching”, “will include”, “will allow”, “will be made” “will continue”, “will occur” or “will be achieved”. We direct readers to refer to the “Caution Regarding Forward-Looking Statements” contained within the Company’s management’s discussion and analysis for the period ended May 31, 2025, as filed on Sedar+ www.sedarplus.ca.

Readers are cautioned to not place undue reliance on forward-looking information. Actual results and developments may differ materially from those contemplated by these statements. Although the Company believes that the expectations reflected in these statements are reasonable, such statements are based on expectations, factors, and assumptions concerning future events which may prove to be inaccurate and are subject to numerous risks and uncertainties, certain of which are beyond the Company’s control, including but not limited to the risk factors discussed in the Company’s management’s discussion and analysis, and elsewhere in this press release, as such factors may be further updated from time to time in our periodic filings, available at www.sedarplus.ca, which factors are incorporated herein by reference. Forward-looking statements contained in this press release are expressly qualified by this cautionary statement and reflect the Company’s expectations as of the date hereof and are subject to change thereafter. The Company undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, estimates or opinions, future events or results, or otherwise, or to explain any material difference between subsequent actual events and such forward-looking information, except as required by applicable law.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy nor shall there be any sale of the securities in any state in which such offer, solicitation or sale would be unlawful. The securities being offered have not been, nor will they be, registered under the United States Securities Act of 1933, as amended, and may not be offered or sold in the United States absent registration or an applicable exemption from the registration requirements of the United States Securities Act of 1933, as amended, and applicable state securities laws.

MAIA Biotechnology Board Members Continue to Participate in Private Placement Financings

MAIA Biotechnology Board Members Continue to Participate in Private Placement Financings




MAIA Biotechnology Board Members Continue to Participate in Private Placement Financings

Purchases reflect strong confidence in the scientific differentiation and commercial potential of ateganosine

CHICAGO, Dec. 24, 2025 (GLOBE NEWSWIRE) — MAIA Biotechnology, Inc. (NYSE American: MAIA) (“MAIA”, the “Company”), a clinical-stage biopharmaceutical company focused on developing targeted immunotherapies for cancer, today announced that independent directors including Adelina Louie Ngar Yee and Stan V. Smith, Ph.D. purchased common stock and warrants in the recent private placement offering which closed on December 22, 2025.

Three directors purchased a total of 179,737 shares and 179,737 warrants with an average purchase price of $1.224. Dr. Smith has invested in all of MAIA’s funding rounds since the Company’s inception in 2018, and Ms. Adelina Louie is a top investor in MAIA. Gross proceeds from the offering totaled approximately $1.51 million.

To date, directors and officers hold 5,019,857 shares or 13.43% of MAIA.

“Ongoing support from our directors reflects their strong conviction in the commercial potential of ateganosine, our first-in-class anticancer treatment for advanced non-small cell lung cancer (NSCLC),” said Vlad Vitoc, M.D., founder and CEO of MAIA. “Consistent insider participation in our 2025 financings strengthens our ability to execute as we advance our pivotal Phase 3 international trial launched this month with first patient dosing.”

Dr. Smith commented, “Our continued support reflects our strong confidence in the scientific differentiation and commercial promise of ateganosine. The initiation of the pivotal Phase 3 trial marks an important value-creation milestone for MAIA.”

Ms. Adelina Louie stated, “I believe MAIA has reached a pivotal stage in advancing life-changing therapies to broad populations of patients with cancer, and I am proud continue to support the Company in my capacity as both an investor and a member of the Board.”

The U.S. Food and Drug Administration (FDA) has granted Fast Track designation for ateganosine for the treatment of NSCLC. Statistical assessments of the Phase 3 trial point to a very high probability of technical success for regulatory approval of ateganosine.

About Ateganosine

Ateganosine (THIO, 6-thio-dG or 6-thio-2’-deoxyguanosine) is a first-in-class investigational telomere-targeting agent currently in clinical development to evaluate its activity in non-small cell lung cancer (NSCLC). Telomeres, along with the enzyme telomerase, play a fundamental role in the survival of cancer cells and their resistance to current therapies. The modified nucleotide 6-thio-2’-deoxyguanosine induces telomerase-dependent telomeric DNA modification, DNA damage responses, and selective cancer cell death. Ateganosine-damaged telomeric fragments accumulate in cytosolic micronuclei and activates both innate (cGAS/STING) and adaptive (T-cell) immune responses. The sequential treatment of ateganosine followed by PD-(L)1 inhibitors resulted in profound and persistent tumor regression in advanced, in vivo cancer models by induction of cancer type–specific immune memory. Ateganosine is presently developed as a second or later line of treatment for NSCLC for patients that have progressed beyond the standard-of-care regimen of existing checkpoint inhibitors.

About MAIA Biotechnology, Inc.

MAIA is a targeted therapy, immuno-oncology company focused on the development and commercialization of potential first-in-class drugs with novel mechanisms of action that are intended to meaningfully improve and extend the lives of people with cancer. Our lead program is ateganosine (THIO), a potential first-in-class cancer telomere targeting agent in clinical development for the treatment of NSCLC patients with telomerase-positive cancer cells. For more information, please visit www.maiabiotech.com.

Forward Looking Statements

MAIA cautions that all statements, other than statements of historical facts contained in this press release, are forward-looking statements. Forward-looking statements are subject to known and unknown risks, uncertainties, and other factors that may cause our or our industry’s actual results, levels or activity, performance or achievements to be materially different from those anticipated by such statements. The use of words such as “may,” “might,” “will,” “should,” “could,” “expect,” “plan,” “anticipate,” “believe,” “estimate,” “project,” “intend,” “future,” “potential,” or “continue,” and other similar expressions are intended to identify forward looking statements. However, the absence of these words does not mean that statements are not forward-looking. For example, all statements we make regarding (i) the initiation, timing, cost, progress and results of our preclinical and clinical studies and our research and development programs, (ii) our ability to advance product candidates into, and successfully complete, clinical studies, (iii) the timing or likelihood of regulatory filings and approvals, (iv) our ability to develop, manufacture and commercialize our product candidates and to improve the manufacturing process, (v) the rate and degree of market acceptance of our product candidates, (vi) the size and growth potential of the markets for our product candidates and our ability to serve those markets, and (vii) our expectations regarding our ability to obtain and maintain intellectual property protection for our product candidates, are forward looking. All forward-looking statements are based on current estimates, assumptions and expectations by our management that, although we believe to be reasonable, are inherently uncertain. Any forward-looking statement expressing an expectation or belief as to future events is expressed in good faith and believed to be reasonable at the time such forward-looking statement is made. However, these statements are not guarantees of future events and are subject to risks and uncertainties and other factors beyond our control that may cause actual results to differ materially from those expressed in any forward-looking statement. Any forward-looking statement speaks only as of the date on which it was made. We undertake no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise, except as required by law. In this release, unless the context requires otherwise, “MAIA,” “Company,” “we,” “our,” and “us” refers to MAIA Biotechnology, Inc. and its subsidiaries.

Investor Relations Contact
+1 (872) 270-3518
ir@maiabiotech.com

Human Appeal launches e-greeting card collection to support emergency charity projects

Human Appeal launches e-greeting card collection to support emergency charity projects




Human Appeal launches e-greeting card collection to support emergency charity projects

New feature enables charity to respond faster to emergencies

MANCHESTER, United Kingdom, Dec. 24, 2025 (GLOBE NEWSWIRE) — Leading UK humanitarian aid charity, Human Appeal, today announces the addition of an e-greeting card feature to its website, which will allow the public the opportunity to send family and friends greeting cards in a selection of categories and make a small donation to support the charity.

Congrats e card 2

Human Appeal’s proprietary research found that charities across the sector are facing the difficulty of a decrease in both donations and volunteers because of the ongoing cost of living crisis. In response, Human Appeal shared an update to its website that includes an e-greeting card with a personalised message. Cards are available to choose from the following greeting categories in a range of unique designs: Congratulations, Thank You, Ramadan Mubarak and Eid Mubarak, and include a customised message from the sender to the recipient.

The digital greeting cards are available to send via Human Appeal’s website for just £3, with proceeds supporting general charity funds where most needed. For many charities like Human Appeal, who are often responding to sudden emergency events such as natural disasters, general funds play a major role in allowing charities to be dynamic and allocate funds to support projects where they are most needed at short notice.

Owais Khan, Deputy CEO of Human Appeal, comments, ‘Charities are facing the ongoing challenges of the cost-of-living crisis as our research revealed. It’s vital that we continue to innovate to ensure that we support the most vulnerable at home and abroad, which isn’t possible without the generous donations of the public. This new addition of our e-greeting card to the Human Appeal website is a way for anyone, regardless of their financial circumstances, to donate and enables us to respond rapidly to humanitarian crises around the world. This is both a way for the public to make a small yet tangible difference whilst sharing messages of good will with loved ones.’

To send an e-card or to find out more, please visit https://humanappeal.org.uk/e-card/

About Human Appeal

Human Appeal is a fully independent British humanitarian charity based in Manchester, UK. It was established in 1991 as a registered and regulated UK charity that runs targeted aid relief programmes in collaboration with recognised global organisations such as the United Nations. Its purpose is to save and transform lives through emergency aid response and sustainable development programmes at home and abroad across 25 countries worldwide.

www.humanappeal.org.uk

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/d331bac8-0329-4e1c-8167-8f7a86f03139

CONTACT: For more information please contact Media Foundry / Percy & Warren

yoan@percywarren.com

DXS International plc (AQSE: DXSP) Update on Cyber Security Incident

DXS International plc (AQSE: DXSP) Update on Cyber Security Incident




DXS International plc (AQSE: DXSP) Update on Cyber Security Incident

24 December 2025

DXS INTERNATIONAL PLC (AQSE: DXSP)

Update on Cyber Security Incident

The Board of DXS International plc (“the Company” or “DXSP”), the AQSE Growth Market quoted healthcare information and digital clinical decision support systems provider, would like to provide an update on the security incident that affected its office servers, which was reported via RNS on 18 December.

The incident has been contained, and DXS remains vigilant by implementing additional monitoring and security measures. 

The Directors of DXS International plc accept responsibility for this announcement.

This announcement contains inside information for the purposes of Article 7 of the UK version of Regulation (EU) No 596/2014 which is part of UK law by virtue of the European Union (Withdrawal) Act 2018, as amended (“MAR”). Upon the publication of this announcement via a Regulatory Information Service, this inside information is now considered to be in the public domain.

Contacts :

David Immelman

DXS International plc

www.dxs-systems.com

 

01252 719800
AQSE Corporate Broker and Corporate Advisor

Hybridan LLP

Claire Louise Noyce

 

020 3764 2341

Notes to Editors

About DXS:

DXS International presents up to date treatment guidelines and recommendations, from Clinical Commissioning Groups and other trusted NHS sources, to doctors, nurses and pharmacists in their workflow and during the patient consultation. This effective clinical decision support ultimately translates to improved healthcare outcomes delivered more cost effectively and which should significantly contribute towards the NHS achieving its projected efficiency savings.

Press Release: Sanofi to acquire Dynavax, adding a marketed adult hepatitis B vaccine and phase 1/2 shingles candidate to the pipeline

Press Release: Sanofi to acquire Dynavax, adding a marketed adult hepatitis B vaccine and phase 1/2 shingles candidate to the pipeline




Press Release: Sanofi to acquire Dynavax, adding a marketed adult hepatitis B vaccine and phase 1/2 shingles candidate to the pipeline

Sanofi to acquire Dynavax, adding a marketed adult hepatitis B vaccine and phase 1/2 shingles candidate to the pipeline

Paris, December 24, 2025. Sanofi announced today that it has entered into an agreement to acquire Dynavax Technologies Corporation (Dynavax), a publicly traded vaccines company with a marketed adult hepatitis B vaccine (HEPLISAV-B®) and differentiated shingles vaccine candidate. The acquisition augments Sanofi’s presence in adult immunization by bringing together Dynavax’s vaccines with Sanofi’s global scale, development capabilities and commercial reach.

Dynavax’s adult hepatitis B vaccine HEPLISAV-B is currently marketed in the US and is differentiated by its two-dose regimen over one month, which enables high levels of seroprotection faster than other hepatitis B vaccines, which are given in three doses over six months.

The acquisition also includes Dynavax’s shingles vaccine candidate (Z-1018), which is currently in phase 1/2 clinical development and additional vaccine pipeline projects.

“Dynavax enhances Sanofi’s adult immunization presence by adding differentiated vaccines that complement Sanofi’s expertise,” said Thomas Triomphe, Executive Vice President, Vaccines, Sanofi. “Its marketed adult hepatitis B vaccine and shingles candidate bring new options to our portfolio and underscore our commitment to providing vaccine protection across the lifespan.”

“Joining Sanofi will provide the global scale and expertise needed to maximize the impact of our vaccine portfolio,” said Ryan Spencer, Chief Executive Officer, Dynavax. “We believe Sanofi’s commercial reach, development capabilities, and commitment to evidence-based immunization will amplify the opportunity for HEPLISAV-B and our innovative pipeline to address important public health needs, further advancing our mission to help protect the world against infectious disease. We are confident that this transaction – and the compelling value it provides – is in the best interests of the Company and its stockholders.”

Hepatitis B and shingles represent a significant public unmet health need and adult vaccination opportunities. In the US alone, nearly 100 million adults born before 1991 remain unvaccinated, with many potentially at risk for infection. Chronic infection with the hepatitis B virus can cause liver damage and lead to cirrhosis and liver cancer. Shingles, which is caused by the varicella zoster virus, affects one in three adults over their lifetime, according to the World Health Organization. In most people, shingles causes a painful, itchy rash but, in some cases it can lead to long-term nerve pain, serious eye infections that can damage the vision, and, rarely, to dangerous inflammation of the brain.

Financial considerations
Under the terms of the merger agreement, Sanofi will commence a cash tender offer to acquire all outstanding shares of Dynavax for $15.50 per share in cash, reflecting a total equity value of approximately $2.2 billion.

The transaction has been unanimously approved by the Dynavax board of directors. The consummation of the tender offer is subject to customary closing conditions, including the tender of a number of shares of Dynavax common stock that represent at least a majority of the outstanding shares of Dynavax common stock, the expiration or termination of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, certain foreign regulatory filings and clearances, and other customary conditions.

If the tender offer is successfully completed, then following the successful completion of the tender offer, a wholly owned subsidiary of Sanofi will merge with and into Dynavax, and all of the outstanding Dynavax common stock that are not tendered in the tender offer will be converted into the right to receive the same $15.50 per share in cash offered to Dynavax shareholders in the tender offer.

Sanofi plans to fund the acquisition with available cash resources.

The agreement to acquire Dynavax is not expected to have any impact on Sanofi’s financial guidance for 2025. Subject to the satisfaction or waiver of customary closing conditions, the acquisition is expected to close in the first quarter of 2026.

About HEPLISAV-B
HEPLISAV-B is an adult hepatitis B vaccine that combines hepatitis B surface antigen with Dynavax’s vaccine adjuvant, a toll-like receptor (TLR) 9 agonist, to enhance the immune response. 

HEPLISAV‑B is an injection given to adults 18 years of age and older to help prevent infection caused by the hepatitis B virus. HEPLISAV‑B is usually given in the arm muscle. HEPLISAV‑B is given in two doses, one month apart, by a healthcare provider.

Important safety information
Do not take HEPLISAV-B if you have a history of severe allergic reaction after a previous dose of any hepatitis B vaccine, or to any ingredient of HEPLISAV‑B, including yeast. HEPLISAV‑B must be given by a medical professional, who will monitor you afterwards, to check for allergic reaction. If you are immunocompromised, or receiving immunosuppressant therapy, you may have less of an immune response to HEPLISAV‑B.

Some people have hepatitis B infection without being aware of it or showing any symptoms. If you already have hepatitis B present in your body, HEPLISAV‑B may not prevent hepatitis B infection.
The most common side effects include pain at the injection site, tiredness, and headache.
Tell your provider if you are pregnant or plan to become pregnant or are breast feeding.
Vaccination with HEPLISAV‑B may not protect all individuals.

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

About Dynavax
Dynavax is a commercial-stage biopharmaceutical company developing and commercializing innovative vaccines to help protect the world against infectious diseases. The Company has two commercial products, HEPLISAV-B® vaccine [Hepatitis B Vaccine (Recombinant), Adjuvanted], which is approved in the US, the European Union and the United Kingdom for the prevention of infection caused by all known subtypes of hepatitis B virus in adults 18 years of age and older. For more information about our marketed products and development pipeline, visit Dynavax.com.

Sanofi Media Relations
Sandrine Guendoul | +33 6 25 09 14 25 | sandrine.guendoul@sanofi.com
Evan Berland | +1 215 432 0234 | evan.berland@sanofi.com  
Léo Le Bourhis | +33 6 75 06 43 81 | leo.lebourhis@sanofi.com  
Victor Rouault | +33 6 70 93 71 40 | victor.rouault@sanofi.com
Timothy Gilbert | +1 516 521 2929 | timothy.gilbert@sanofi.com
Léa Ubaldi | +33 6 30 19 66 46 | lea.ubaldi@sanofi.com
Ekaterina Pesheva | +1 410 926 6780 | ekaterina.pesheva@sanofi.com

Sanofi Investor Relations
Thomas Kudsk Larsen | +44 7545 513 693 | thomas.larsen@sanofi.com  
Alizé Kaisserian | +33 6 47 04 12 11 | alize.kaisserian@sanofi.com
Keita Browne | +1 781 249 1766 | keita.browne@sanofi.com
Nathalie Pham | +33 7 85 93 30 17 | nathalie.pham@sanofi.com
Thibaud Châtelet | +33 6 80 80 89 90 | thibaud.chatelet@sanofi.com
Yun Li | +33 6 84 00 90 72 | yun.li3@sanofi.com

Additional Information for US Shareholders and Where to Find It
The tender offer for the outstanding shares of Dynavax Technologies Corporation common stock (“Dynavax”) referenced in this communication has not yet commenced. This communication is for informational purposes only and is neither an offer to purchase nor a solicitation of an offer to sell shares of Dynavax, nor is it a substitute for the tender offer materials that Sanofi and its acquisition subsidiary will file with the US Securities and Exchange Commission (the “SEC”) upon commencement of the tender offer. At the time the tender offer is commenced, Sanofi and its acquisition subsidiary will file tender offer materials on Schedule TO, and Dynavax will file a Solicitation/Recommendation Statement on Schedule 14D-9 with the SEC with respect to the tender offer. The tender offer materials (including an Offer to Purchase, a related Letter of Transmittal and certain other tender offer documents) and the Solicitation/Recommendation Statement will contain important information. HOLDERS OF SHARES OF DYNAVAX ARE URGED TO READ THESE DOCUMENTS WHEN THEY BECOME AVAILABLE BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION THAT DYNAVAX STOCKHOLDERS SHOULD CONSIDER BEFORE MAKING ANY DECISION REGARDING TENDERING THEIR SHARES. The Offer to Purchase, the related Letter of Transmittal and certain other tender offer documents, as well as the Solicitation/Recommendation Statement, will be made available to all holders of shares of Dynavax at no expense to them. The tender offer materials and the Solicitation/Recommendation Statement will be made available for free at the SEC’s web site at www.sec.gov. Additional copies may be obtained for free by contacting Sanofi’s Investor Relations Team at investor.relations@sanofi.com or on Sanofi’s website at https://www.sanofi.com/en/investors.

In addition to the Offer to Purchase, the related Letter of Transmittal and certain other tender offer documents, as well as the Solicitation/Recommendation Statement, Sanofi files annual and special reports and other information with the SEC and Dynavax files annual, quarterly and special reports and other information with the SEC. You may read and copy any reports or other information filed by Sanofi and Dynavax at the SEC public reference room at 100 F. Street, N.E., Washington D.C. 20549. Please call the Commission at 1-800-SEC-0330 for further information on the public reference room. Sanofi’s and Dynavax’s filings with the SEC are also available to the public from commercial document-retrieval services and at the website maintained by the SEC at www.sec.gov.

Sanofi forward looking statement
This press release contains forward-looking statements that are subject to risks, uncertainties and other factors that could cause actual results to differ materially from those implied by the forward-looking statements. Forward-looking statements are statements that are not historical facts and may include projections and estimates and their underlying assumptions, statements regarding plans, objectives, intentions and expectations with respect to future financial results, events, operations, services, product development and potential, and statements regarding future performance. Forward-looking statements are generally identified by the words “expects”, “anticipates”, “believes”, “intends”, “estimates”, “plans”, “will be” and similar expressions. Although Sanofi’s management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Sanofi, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, unexpected regulatory actions or delays, or government regulation generally, that could affect the availability or commercial potential of the product, or the fact that the product may not be commercially successful, and risks related to Sanofi’s and Dynavax’s ability to complete the acquisition on the proposed terms or on the proposed timeline or at all, including the receipt of required regulatory approvals, the risk that the conditions to the closing of the transaction may not be satisfied, the possibility that competing offers will be made, the risk of securityholder litigation relating to the proposed acquisition, including resulting expense or delays, other risks associated with executing business combination transactions, such as the risk that the businesses will not be integrated successfully, that such integration may be more difficult, time-consuming or costly than expected or that the expected benefits of the acquisition will not be realized, risks related to future opportunities and plans for the combined company, including uncertainty of the expected financial performance and results of the combined company following completion of the proposed acquisition, disruption from the proposed acquisition making it more difficult to conduct business as usual or to maintain relationships with customers, employees, manufacturers, suppliers or patient groups, and the possibility that, if the combined company does not achieve the perceived benefits of the proposed acquisition as rapidly or to the extent anticipated by financial analysts or investors, the market price of Sanofi’s shares could decline, as well as other risks related to Sanofi’s and Dynavax’s respective businesses, including the ability to grow sales and revenues from existing products and to develop, commercialize or market new products, competition, including potential generic competition, the uncertainties inherent in research and development, including future clinical data and analysis, regulatory obligations and oversight by regulatory authorities, such as the FDA or the EMA, including decisions of such authorities regarding whether and when to approve any drug, device or biological application that may be filed for any product candidates as well as decisions regarding labelling and other matters that could affect the availability or commercial potential of any product candidates, the absence of a guarantee that any product candidates, if approved, will be commercially successful, the future approval and commercial success of therapeutic alternatives, Sanofi’s ability to benefit from external growth opportunities, to complete related transactions and/or obtain regulatory clearances, risks associated with intellectual property and any related pending or future litigation and the ultimate outcome of such litigation, trends in exchange rates and prevailing interest rates, volatile economic and market conditions, cost containment initiatives and subsequent changes thereto, and the impact that global crises may have on us, our customers, suppliers, vendors, and other business partners, and the financial condition of any one of them, as well as on our employees and on the global economy as a whole. While the list of factors presented here is representative, no list should be considered a statement of all potential risks, uncertainties or assumptions that could have a material adverse effect on companies’ consolidated financial condition or results of operations. The foregoing factors should be read in conjunction with the risks and cautionary statements discussed or identified in the public filings with the US Securities and Exchange Commission (the “SEC”) and the Autorité des marchés financiers made by Sanofi, including those listed under “Risk Factors” and “Cautionary Statement Regarding Forward-Looking Statements” in Sanofi’s annual report on Form 20-F for the year ended December 31, 2024 and its other filings with the SEC and the current reports on Form 8-K, quarterly reports on Form 10-Q and annual reports on Form 10-K and other filings with the SEC filed by Dynavax. The forward-looking statements speak only as of the date hereof and, other than as required by applicable law, Sanofi and Dynavax do not undertake any obligation to update or revise any forward-looking information or statements. 

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Best Peptides for Muscle Growth: Prescription Sermorelin Access, Injectable vs. Dissolving Tablets, and Realistic Expectations

Best Peptides for Muscle Growth: Prescription Sermorelin Access, Injectable vs. Dissolving Tablets, and Realistic Expectations




Best Peptides for Muscle Growth: Prescription Sermorelin Access, Injectable vs. Dissolving Tablets, and Realistic Expectations

Platform Analysis: Injectable vs. Dissolving Tablet Formats, Prescription Requirements, Monthly Subscription Costs, and Timeline Expectations for Growth Hormone Secretagogue Therapy

AUSTIN, Dec. 23, 2025 (GLOBE NEWSWIRE) — Disclaimer: This article is for informational purposes only. It is not medical advice. “Best” in this context is defined by verification and service-model factors (format accessibility, pricing transparency as presented by the company, provider independence, and disclosure quality)—not clinical superiority or guaranteed outcomes. Sermorelin acetate previously appeared in an FDA-approved branded product (Geref) used in pediatric growth hormone deficiency contexts; that product was later discontinued and listed by FDA as discontinued for reasons other than safety or effectiveness. Many modern programs provide sermorelin via pharmacy compounding, and compounded medications are not FDA-approved as finished products. Evaluation by a licensed clinician is required for prescription medications, and prescription approval is not guaranteed. Always consult a qualified healthcare professional before starting prescription treatments. If you purchase through links in this article, a commission may be earned at no additional cost to you.

Best Peptides for Muscle Growth Prescription Sermorelin Access, Injectable vs. Dissolving Tablets, and Realistic Expectations

If you’re searching for “best peptides for muscle growth” in late 2025, you’re likely evaluating hormone optimization strategies for recovery, body composition, and 2026 fitness goals. Here’s what ReadyRx’s prescription sermorelin platform actually offers—and what it doesn’t guarantee.

Sermorelin is a synthetic peptide that stimulates the body’s natural growth hormone production. According to the company, it has emerged as one prescription option in the hormone optimization category—though it requires medical supervision by independent licensed providers, comes with realistic timelines measured in months rather than weeks, and is not a substitute for proper training and nutrition.

According to the company, ReadyRx presents sermorelin as a subscription-based prescription program, with pricing shown during the eligibility and checkout flow and subject to change based on plan selection and other factors. The platform positions these options as accessible alternatives to direct growth hormone replacement, framed around sleep quality, recovery support, and gradual body composition changes rather than rapid muscle-building claims. Readers should confirm current pricing directly on the official ReadyRx page before making a purchase decision.

View the current Sermorelin Rx offer (official ReadyRx page)

Before diving into product specifics, it’s critical to understand what sermorelin is—and what it is not. This is a compounded prescription medication prepared by a licensed pharmacy based on an individual prescription from an independent medical provider. It is not an over-the-counter supplement, not an anabolic steroid, and not a guaranteed solution for muscle growth. As discussed above, current sermorelin access typically occurs via pharmacy compounding rather than FDA-approved finished products. Use in adults for wellness, fitness, or body composition purposes represents off-label prescribing, which is legal and common but means the specific application does not carry FDA approval for that indication.

ReadyRx is a telehealth platform connecting users with independent licensed medical providers who evaluate whether sermorelin therapy is appropriate based on individual health factors. The platform itself is not a healthcare provider, does not prescribe medications, and does not guarantee that any individual will receive a prescription. That determination rests entirely with the evaluating clinician.

This article examines what sermorelin therapy involves, how the ReadyRx platform facilitates access to it, what realistic expectations look like based on ingredient-level research, who may or may not be appropriate candidates, and what the regulatory landscape means for anyone considering peptide therapy heading into 2026.

Understanding the Search: Why “Best Peptides for Muscle Growth” Leads Here

The phrase “best peptides for muscle growth” reflects a specific moment in a fitness enthusiast’s research journey. They’ve likely seen social media content about peptide therapy, heard anecdotal reports about recovery improvements, or read about growth hormone secretagogues as alternatives to direct HGH replacement. They’re now looking for concrete options, comparative information, and some validation that what they’re considering is legitimate.

Sermorelin enters this conversation because it is one of the most widely prescribed peptides for hormone optimization in the United States. Unlike experimental or research-grade peptides that exist in regulatory gray zones, sermorelin acetate is an FDA-recognized compound with established medical use, though most prescribing for fitness and wellness purposes occurs off-label.

Here’s how the search intent typically breaks down:

What people want: A peptide that will help them build muscle faster, recover from workouts more efficiently, and achieve better body composition results.

What sermorelin actually does: Stimulates the pituitary gland to increase the body’s own production of growth hormone, which may support improved sleep quality, enhanced recovery, gradual improvements in lean mass over several months, and metabolic benefits—when combined with proper training, nutrition, and lifestyle factors.

The gap between expectation and reality: Sermorelin is not a rapid muscle-building compound. It does not produce the dramatic anabolic effects of synthetic growth hormone or anabolic steroids. People who respond well to sermorelin therapy typically report noticing improved sleep quality within weeks, modest changes in body composition by month three, and more significant cumulative benefits by months six through twelve. Individual experiences vary widely.

According to the ReadyRx website, sermorelin is positioned as supporting “natural growth hormone production” to help with “lean muscle, reduced recovery time, deeper sleep, and improved energy levels.” These claims represent the company’s marketing messaging about potential benefits—individual results are not guaranteed, and these outcomes have not been verified by FDA review of compounded sermorelin products.

The platform offers two delivery methods: injectable sermorelin (10mg vials requiring self-administration) and dissolving tablets (1000mcg, marketed as the needle-free option). Both require a prescription from one of the platform’s affiliated independent providers following a telehealth evaluation.

View the current Sermorelin Rx offer (official ReadyRx page)

What Is Sermorelin? The Science Behind Growth Hormone Secretagogues

Sermorelin acetate is a synthetic peptide consisting of the first 29 amino acids of growth hormone-releasing hormone (GHRH), the naturally occurring compound that signals the pituitary gland to produce and release growth hormone. This compound previously appeared in an FDA-approved branded medication used for specific medical indications; current access typically occurs via pharmacy compounding. By mimicking the natural GHRH signal, sermorelin encourages the body to increase its own growth hormone output rather than introducing synthetic growth hormone directly.

This distinction matters for several reasons:

Regulation of production: When you stimulate natural growth hormone production with sermorelin, the body’s feedback mechanisms remain intact. The pituitary gland can still respond to other signals and adjust output based on physiological needs. Direct growth hormone replacement bypasses these controls.

Pulsatile release: Natural growth hormone is released in pulses throughout the day, with the largest pulse typically occurring during deep sleep. Sermorelin works within this natural rhythm rather than creating sustained elevated levels.

Safety profile: Because sermorelin stimulates rather than replaces, the risk profile differs from exogenous growth hormone. However, this does not mean sermorelin is risk-free or appropriate for everyone.

Individual variability: Response to sermorelin depends heavily on individual pituitary function, baseline growth hormone levels, age, lifestyle factors, and other variables. Two people taking the same dose may experience very different outcomes. Prescription approval is not guaranteed—the independent clinician determines appropriateness based on your specific health factors.

Sermorelin is typically prescribed in microgram or milligram doses administered via subcutaneous injection, usually before bed to align with natural growth hormone release patterns. According to the ReadyRx website, the injectable format provides 10mg vials, while the sublingual format provides 1000mcg tablets that dissolve under the tongue.

The sublingual format represents a newer delivery method marketed as more convenient than injections. However, absorption rates and bioavailability may differ between injection and sublingual administration, and individual response can vary.

What Growth Hormone Does in the Body

To understand why people pursue sermorelin therapy for fitness and body composition goals, it helps to understand what growth hormone actually does:

Protein synthesis: Growth hormone promotes the uptake of amino acids and their incorporation into proteins, supporting muscle tissue repair and growth.

Lipolysis: Growth hormone stimulates the breakdown of stored fat for energy, potentially supporting fat loss when combined with appropriate caloric intake and exercise.

Bone density: Growth hormone plays a role in bone remodeling and mineral density.

Metabolic regulation: Growth hormone influences how the body processes carbohydrates, proteins, and fats.

Recovery: Growth hormone is involved in tissue repair processes that occur during sleep and rest periods.

These functions are why athletes, fitness enthusiasts, and aging adults became interested in growth hormone optimization. However, directly administering synthetic growth hormone comes with significant medical oversight requirements, costs, and potential side effects—which is why growth hormone secretagogues like sermorelin have become popular alternatives.

The important caveat: Sermorelin does not produce the same magnitude of effect as direct growth hormone replacement. It works within the body’s existing capacity to produce growth hormone, which means results are more modest, develop more gradually, and depend heavily on individual baseline function.

ReadyRx Platform Structure: Three Entities You Need to Understand

Before discussing the sermorelin products themselves, it’s essential to understand how the ReadyRx system works, because this structure has important implications for how you access treatment, who is responsible for medical decisions, and what happens if issues arise.

ReadyRx operates as a three-entity system:

Entity 1: ReadyRx (The Platform)

ReadyRx is the technology platform that facilitates connections between patients and healthcare providers. According to the company’s terms of use, ReadyRx (operated by Executive Medical, LLC) is explicitly not a healthcare provider.

The platform provides:

  • Technology infrastructure for telehealth consultations
  • Customer service and coordination
  • Prescription fulfillment logistics
  • Payment processing
  • Educational content and user support

The platform cannot prescribe medications, make medical decisions, or guarantee that any individual will receive a prescription. Those determinations belong to the independent medical providers.

Entity 2: Independent Licensed Medical Providers

According to the company’s disclosures, ReadyRx connects users with independent licensed healthcare professionals who review patient information and determine whether prescriptions are appropriate.

These providers:

  • Make all clinical decisions independently
  • Are responsible for medical evaluation and diagnosis
  • Determine whether sermorelin therapy is suitable for each individual
  • Cannot guarantee prescriptions will be issued
  • Must follow applicable medical standards and regulations

The platform states that it “does not control or interfere with the practice of medicine” and that providers are “solely responsible for directing the medical care and treatment they provide.”

Entity 3: Compounding Pharmacies

Sermorelin prescribed through ReadyRx is prepared as a compounded medication by licensed U.S. pharmacies. According to the website, these medications are:

  • Compounded based on individual prescriptions
  • Sourced from FDA-registered facilities
  • Subject to third-party lab testing for potency, sterility, pH level, and endotoxicity
  • Shipped directly to patients in temperature-controlled packaging

Critical compliance note: Compounded medications are not reviewed or approved by the FDA as finished products. Unlike FDA-approved drugs, compounded medications are not individually evaluated by the FDA for safety, effectiveness, or quality before being dispensed. They are prepared by pharmacies under federal and state compounding rules, and the evaluating clinician determines whether this option is appropriate based on individual health factors.

This three-entity structure is common across telehealth platforms and ensures appropriate separation between the technology platform, clinical decision-making, and medication dispensing. However, it means you need to understand that your relationship with ReadyRx (the platform) is distinct from your relationship with your prescribing provider and the compounding pharmacy.

Injectable Sermorelin: 10mg Vials for Self-Administration

According to the company, the injectable sermorelin option provides 10mg vials designed for subcutaneous self-injection. ReadyRx presents this as a subscription-based prescription program, with pricing shown during the eligibility and checkout flow and subject to change based on plan selection. Confirm current pricing and terms directly on the official ReadyRx page.

Injectable Administration

Administration details (timing, technique, storage, and dosing) should be provided directly by the prescribing clinician and dispensing pharmacy. Patients should follow their individualized prescription instructions and ask the clinician about safe administration practices, proper injection technique training, and any storage requirements.

Why Some Users Prefer Injectable Format

The injectable format has been the traditional delivery method for sermorelin therapy and offers several potential advantages:

Bioavailability: Subcutaneous injection bypasses digestive system metabolism, potentially offering more predictable absorption compared to oral or sublingual routes.

Dosing control: Injectable formats allow for precise dose adjustments based on individual response and provider recommendations.

Established protocols: Most clinical research on sermorelin involves injectable administration, providing more historical data on typical response patterns.

However, injectable therapy also requires:

  • Comfort with self-injection
  • Proper injection technique training
  • Needle disposal considerations
  • Storage and handling requirements

For individuals who are needle-averse or travel frequently, the injection requirement may be a barrier—which is where the sublingual format enters consideration.

Dissolving-Tablet Sermorelin: The Needle-Free Alternative

According to the company, the ReadyRx dissolving-tablet option provides 1000mcg orally dissolving tablets (ODT) that dissolve under the tongue. ReadyRx presents this as a subscription-based prescription program, with pricing shown during the eligibility and checkout flow. Confirm current pricing on the official ReadyRx page.

The company’s marketing emphasizes this as “hormone support without the needle” and “more muscle, no needles,” positioning it as a convenience-focused alternative for users who prefer to avoid injections.

How Sublingual Delivery Works

Sublingual administration involves placing the tablet under the tongue where it dissolves and is absorbed through the mucous membranes directly into the bloodstream. This route:

  • Bypasses first-pass liver metabolism (unlike swallowed oral medications)
  • Offers faster absorption than traditional oral routes
  • Avoids needles and injection site reactions
  • May be more convenient for travel and daily use

However, sublingual bioavailability for peptides can be variable. Factors that affect absorption include:

  • Individual differences in sublingual tissue vascularity
  • Saliva production and pH
  • Proper administration technique (not swallowing, allowing complete dissolution)
  • Concurrent food or drink consumption

According to the company, the dissolving-tablet format provides “1000mcg” dosing. The company describes this as “one of the highest oral dosing options available” for sermorelin, suggesting they position it as competitive with injectable formats despite the different delivery method.

Comparing Injectable vs. Sublingual: What to Consider

For individuals evaluating which format might be more appropriate, several factors come into play:

Convenience: Dissolving tablets eliminate needle anxiety, simplify travel, and remove injection site concerns. This may improve adherence for users who would otherwise skip doses due to injection hesitation.

Absorption predictability: Injectable sermorelin has more established pharmacokinetic data. Dissolving-tablet absorption can vary more between individuals.

Cost: According to the company, both formats are presented within the same subscription program structure. Confirm current pricing and any format-specific differences on the official page.

Clinical history: Most research on sermorelin for growth hormone stimulation involves injectable administration. Less long-term data exists on dissolving-tablet formats.

Individual response: Some users may respond better to one format over the other based on their unique physiology, absorption patterns, and tolerance.

The prescribing provider would make recommendations based on the patient’s preferences, medical history, and treatment goals. Neither format is inherently “better”—the appropriate choice depends on individual circumstances.

Realistic Expectations: What Sermorelin Can and Cannot Do

One of the most important aspects of considering sermorelin therapy is understanding realistic timelines and outcomes. The gap between social media claims and actual clinical experience can be significant.

What Research Suggests About Growth Hormone Secretagogues

Clinical research on sermorelin and similar growth hormone secretagogues has explored various endpoints:

Sleep quality: Some studies suggest growth hormone secretagogues may support deeper sleep and improved sleep architecture, which could indirectly benefit recovery and body composition.

Body composition changes: Research in specific populations has shown modest improvements in lean body mass and reductions in fat mass over periods of several months. These changes are typically smaller than those seen with direct growth hormone replacement.

Recovery markers: Some data suggests improved recovery from exercise in specific contexts, though results vary widely.

Age-related decline: Studies in aging populations have explored whether growth hormone secretagogues can partially reverse age-related changes in hormone levels, body composition, and physical function.

This is ingredient-level research; sermorelin as a finished compounded product prescribed through ReadyRx has not been clinically studied in the way FDA-approved drugs are evaluated. Compounded medications are not FDA-approved; the FDA does not verify their safety, effectiveness, or quality before they are marketed. Individual results will vary based on factors including age, baseline hormone levels, body composition, training status, nutrition, sleep quality, stress levels, genetics, and consistency of use.

Typical Timeline for Sermorelin Therapy (When Response Occurs)

According to the ReadyRx website and general peptide therapy protocols, clinical discussions sometimes reference changes along this rough pattern for individuals who respond to therapy, though individual experiences vary widely and results are not guaranteed:

Weeks 1-4: Improved sleep quality is sometimes described as the first noticeable change in clinical discussions. Some individuals may report feeling more rested upon waking and experiencing deeper sleep. Energy levels may begin to improve. Individual results are not guaranteed.

Weeks 4-12: Gradual improvements in recovery from exercise may become apparent for some individuals. Recovery patterns vary widely between users. Subtle changes in body composition may begin, though these are typically not dramatic. Results are not guaranteed.

Months 3-6: Body composition changes may become more apparent for individuals who respond well and maintain proper training and nutrition. This may include modest increases in lean mass and reductions in body fat percentage for some users. Skin quality improvements are sometimes referenced in clinical discussions. Individual experiences vary significantly.

Months 6-12+: Cumulative benefits may continue to develop for some long-term users. However, response tends to plateau, and benefits are maintained rather than continuing to accelerate indefinitely. Not all users experience dramatic benefits.

These timelines assume:

  • Consistent daily use
  • Proper dosing as prescribed
  • Adequate protein intake
  • Regular resistance training
  • Sufficient sleep
  • Managed stress levels
  • No significant disruptions to treatment

Even with all these factors optimized, not everyone experiences dramatic benefits. Some individuals see modest improvements, some see minimal changes, and individual variability is high.

What Sermorelin Will NOT Do

Setting appropriate expectations requires being equally clear about what sermorelin is not:

Not a rapid muscle builder: Sermorelin will not produce the dramatic muscle-building effects of anabolic steroids or even direct growth hormone replacement. Changes occur gradually over months.

Not a substitute for training and nutrition: Sermorelin cannot compensate for inadequate training stimulus, insufficient protein intake, poor sleep, or caloric imbalances. It may support optimization when fundamentals are already in place.

Not universally effective: Some individuals will not respond noticeably to sermorelin therapy, either because their baseline growth hormone production is already adequate, their pituitary response is limited, or other physiological factors prevent significant benefit.

Not a weight loss solution: While sermorelin may support modest improvements in body composition, it is not a weight loss medication. Any fat loss effects are secondary to improved hormone balance, enhanced recovery enabling more training, and better sleep supporting metabolic health.

Not risk-free: While generally considered to have a favorable safety profile compared to direct growth hormone replacement, sermorelin is not without potential side effects and contraindications. Prescription approval is not guaranteed.

According to the ReadyRx website, providers evaluate whether sermorelin is appropriate for individuals based on their specific health factors. Prescription approval is not guaranteed—not everyone who applies will receive a prescription.

Who Sermorelin May Be Right For (Self-Assessment Framework)

Rather than relying on testimonials or claims about typical results, a more valuable approach is to consider whether your situation and goals align with what sermorelin therapy offers when it works well.

Sermorelin May Align Well With People Who:

Have optimized the fundamentals: You already train consistently with a well-designed program, maintain adequate protein intake, sleep 7-9 hours nightly, and manage stress—but feel you’ve reached a plateau where additional optimization might help.

Are comfortable with gradual progress: You understand that peptide therapy is measured in months, not weeks, and are patient enough to allow cumulative effects to develop.

Have realistic body composition goals: You’re looking for modest improvements in lean mass and body fat percentage over time, not dramatic transformations.

Value sleep and recovery: Improved sleep quality and enhanced recovery are meaningful benefits for you, even if muscle growth effects are modest.

Are at least 25 years old: According to the ReadyRx website, sermorelin is generally prescribed for adults over 25. The platform’s online service is intended for users 18 and older, but age-related considerations affect appropriateness.

Can commit financially: According to the company, ReadyRx presents sermorelin as a subscription-based program with pricing shown during eligibility and checkout. Benefits described in clinical contexts typically require several months of consistent use to develop. Confirm current pricing on the official page to evaluate financial sustainability.

Are comfortable with medical oversight: You understand this is a prescription medication requiring evaluation by a licensed clinician and periodic follow-up.

Other Options May Be Preferable For People Who:

Have suboptimal training or nutrition: If your training program is poorly designed, your protein intake is inadequate, or your sleep is consistently poor, addressing these factors will provide far greater returns than any peptide therapy.

Expect rapid results: If you’re looking for dramatic muscle growth within weeks, sermorelin is not the appropriate intervention.

Have limited budgets: At $185/month ongoing, sermorelin represents a significant monthly expense. If this would strain your budget, optimizing training, nutrition, and sleep will provide better value.

Have specific health contraindications: Sermorelin is not appropriate for people with active cancer, uncontrolled diabetes, severe sleep apnea, or complete growth hormone deficiency requiring recombinant HGH.

Are under 25 with normal hormone function: Younger individuals with healthy baseline growth hormone levels are less likely to benefit significantly.

Prefer injectable testosterone therapy: For individuals with diagnosed hypogonadism, testosterone replacement therapy may be more appropriate and effective than sermorelin for body composition goals, though this is a different clinical indication.

Questions to Ask Yourself

Before pursuing sermorelin therapy, consider:

  • Have I optimized training, nutrition, and sleep to the point where additional intervention might be beneficial?
  • Am I prepared to commit to several months of consistent use before evaluating effectiveness?
  • Do I understand that response varies widely and benefits are not guaranteed?
  • Is the monthly cost sustainable for the 6-12 month timeline when benefits typically develop?
  • Am I comfortable with either self-injection or sublingual administration?
  • Have I researched potential side effects and contraindications?

Your answers help determine which peptide therapy characteristics matter most for your specific situation—and whether pursuing a prescription evaluation makes sense.

The ReadyRx Process: How Telehealth Evaluation Works

For individuals who determine sermorelin therapy aligns with their goals and situation, the ReadyRx platform facilitates access through a telehealth evaluation process.

Step 1: Initial Health Intake

According to the website, the process begins with a health intake assessment where you provide information about your medical history, current medications, health conditions, and treatment goals. This information is reviewed by one of the platform’s affiliated independent providers.

Critical requirement: You must be located in a state where ReadyRx offers services and where the affiliated providers are licensed. According to the terms of use, you must be located in the same state as your shipping address at the time of consultation.

Step 2: Provider Evaluation

An independent licensed medical provider reviews your intake information and determines whether a prescription is appropriate. According to the platform’s terms, this determination is made by the provider independently—ReadyRx cannot guarantee any individual will receive a prescription.

The provider evaluates whether:

  • You meet age requirements (generally 25+)
  • You have no contraindications (active cancer, uncontrolled diabetes, etc.)
  • Sermorelin therapy is medically appropriate for your situation
  • The potential benefits outweigh risks for your specific case

If the provider determines sermorelin is not appropriate, you may receive recommendations for alternative approaches or suggestions to address underlying factors first.

Step 3: Prescription and Fulfillment

If a prescription is written, the medication is prepared by one of ReadyRx’s partner compounding pharmacies and shipped directly to your address. According to the website:

  • Free overnight shipping is included
  • Packaging is temperature-controlled and discreet
  • First shipment may be charged early to prevent treatment gaps
  • Subscriptions auto-renew unless canceled

The platform states that medications undergo third-party lab testing for potency, sterility, pH level, and endotoxicity before being dispensed.

Step 4: Ongoing Support and Monitoring

According to the website, ReadyRx provides:

  • Unlimited physician messaging
  • Personalized protocols
  • Meal plans and coaching
  • Periodic outreach to check in on progress

However, the level of active monitoring and follow-up may vary. Users should proactively communicate with their providers about response, side effects, or concerns rather than assuming automatic oversight.

Step 5: Subscription Management

Sermorelin through ReadyRx operates on an auto-renewing subscription model. According to the terms of use:

  • Subscriptions renew automatically unless canceled
  • You can cancel at any time by emailing support@readyrx.com
  • Cancellation takes effect at the end of the current subscription period
  • No refunds for partially used subscription periods (though case-by-case exceptions may occur)
  • You must cancel at least 4 business days before renewal to avoid the next charge

For users who travel or need to pause treatment, the platform may offer pause options for specified periods, after which charging resumes automatically unless you cancel.

Safety Considerations: What to Know Before Starting

Sermorelin contains prescription-strength active compounds. While generally considered to have a favorable safety profile compared to direct growth hormone replacement, it is not risk-free.

Common Side Effects (When They Occur)

According to general peptide therapy literature and the ReadyRx website’s safety information, potential side effects include:

Injection site reactions (injectable format): Redness, swelling, itching, or pain at injection sites. Rotating injection sites and proper technique can minimize these.

Headaches: Some users report headaches, particularly when first starting therapy or when doses are adjusted.

Flushing: A feeling of warmth or flushed skin may occur, especially shortly after administration.

Nausea or stomach discomfort: Some individuals experience digestive upset, particularly with sublingual formats.

Dizziness or lightheadedness: Changes in hormone levels can occasionally cause temporary dizziness.

Hyperactivity or difficulty sleeping: Some users report feeling “wired” or having difficulty falling asleep despite using sermorelin before bed. Timing adjustments may help.

Most side effects are mild and resolve with continued use or dose adjustments. However, persistent or severe side effects should be reported to your prescribing provider.

Contraindications and Who Should NOT Use Sermorelin

According to the ReadyRx website and general medical guidance, sermorelin may not be appropriate for individuals with:

Active cancer: Growth hormone can stimulate cell growth, including potentially cancer cells. Sermorelin is generally not recommended for individuals with active cancer.

Uncontrolled diabetes: Growth hormone affects glucose metabolism. Uncontrolled blood sugar is a relative contraindication.

Severe sleep apnea: Growth hormone therapy may worsen sleep apnea in some cases.

Complete growth hormone deficiency: Individuals with complete pituitary failure requiring recombinant growth hormone replacement would not be appropriate candidates for sermorelin, which requires functional pituitary capacity.

Pregnancy or breastfeeding: Safety has not been established in pregnant or breastfeeding individuals.

Certain cardiovascular conditions: Individuals with specific heart conditions should discuss risks with their provider.

Pediatric use: While sermorelin is FDA-approved for growth hormone deficiency in children, the ReadyRx platform serves adults and the context here is adult wellness use.

The prescribing provider evaluates individual risk factors and determines whether sermorelin therapy is medically appropriate based on your specific health profile.

Medication Interactions

Sermorelin may interact with certain medications, including:

  • Thyroid medications: Growth hormone can affect thyroid function; dosing adjustments may be needed.
  • Diabetes medications: Blood sugar monitoring may require closer attention.
  • Corticosteroids: May reduce response to sermorelin.

Always disclose all current medications, supplements, and health conditions to your prescribing provider.

Monitoring and Follow-Up

Responsible sermorelin therapy should include:

  • Periodic check-ins with your provider about response, side effects, and whether continuation is appropriate
  • Blood work monitoring in some cases, though not all providers require regular lab testing
  • Honest self-assessment of whether benefits justify ongoing costs and potential risks

The ReadyRx platform includes “unlimited physician messaging,” allowing users to report concerns or ask questions. However, proactive communication is your responsibility—don’t assume issues will be caught automatically.

A Note on Safety Reporting

This safety overview is not exhaustive and does not replace the patient drug education or official prescribing information that should be provided with your prescription. Always review full safety information from your prescriber and pharmacist, and report any concerning symptoms promptly.

Pricing Structure and Cost Considerations

According to the company, ReadyRx presents sermorelin as a subscription-based prescription program, with pricing shown during the eligibility and checkout flow and subject to change based on plan selection and other factors. Readers should confirm current pricing directly on the official ReadyRx page before making purchase decisions.

What’s Included in the Subscription

According to the website, the subscription price covers:

  • Provider consultation fee: The cost of the telehealth evaluation and ongoing provider access is built into the subscription price rather than charged separately.
  • Medication cost: The compounded sermorelin prescription itself.
  • Shipping: Free overnight delivery in temperature-controlled packaging.
  • Support services: Access to personalized protocols, meal planning guidance, and coaching resources.

This bundled pricing model simplifies the user experience but means you’re paying a single total that includes multiple components (platform access, medical consultation, pharmacy services).

Cost Comparison Considerations

For context on the telehealth peptide therapy market:

  • Traditional growth hormone replacement therapy typically costs $500-$1,500+ monthly, making sermorelin programs significantly less expensive (though also less potent).
  • Compounded testosterone therapy ranges from $100-$300 monthly depending on protocol.
  • Many peptide therapy clinics charge separate consultation fees, lab fees, and medication costs, which can add up to similar or higher totals.

ReadyRx’s pricing structure is competitive within the telehealth peptide therapy market, though individual local compounding pharmacies or clinics may offer different pricing structures. Always verify current pricing on the official page.

Insurance and HSA/FSA Considerations

According to the website and terms of use:

  • No insurance accepted: ReadyRx explicitly does not participate in Medicare, Medicaid, or private insurance programs for these services. You are paying entirely out-of-pocket.
  • HSA/FSA eligible: The platform states that sermorelin therapy may be eligible for Health Savings Account (HSA) or Flexible Spending Account (FSA) reimbursement. Verify with your specific plan administrator.
  • No insurance claims: By using the service, you agree that neither you nor ReadyRx will submit claims to any insurance program for reimbursement.

Many direct-to-consumer prescription products are not covered by traditional insurance plans, but coverage policies vary. Always confirm benefits directly with your insurer if you have questions about potential coverage.

Subscription Management and Cancellation

According to the terms of use:

  • You may cancel your subscription at any time by emailing support@readyrx.com
  • Cancellation takes effect at the end of your current subscription period
  • Refunds are generally not provided for partially used subscription periods
  • However, refunds may be provided case-by-case at ReadyRx’s discretion
  • If a product becomes unavailable during a pre-paid period, ReadyRx will offer alternatives or pro-rata refunds

To avoid unwanted charges, cancel at least 4 business days before your next renewal date.

Regulatory Context: Peptide Therapy Under FDA Oversight

Important note: The peptide therapy industry, including compounded sermorelin products, has been under increased regulatory scrutiny in recent years. Anyone considering peptide therapy should be aware of the evolving regulatory landscape.

FDA Position on Compounded Medications

The FDA distinguishes between:

FDA-approved drugs: These have undergone rigorous clinical trials demonstrating safety and efficacy for specific indications. They are manufactured under strict quality controls and are reviewed by the FDA before approval.

Compounded medications: These are prepared by pharmacies based on individual prescriptions. They are not individually reviewed or approved by the FDA as finished products. They use active ingredients that may be recognized by FDA but are prepared in custom formulations.

Compounded medications are legal and serve important medical needs, particularly for patients who need customized dosing, alternative formulations, or discontinued drugs. However, they are held to different standards than FDA-approved products.

According to the ReadyRx website and terms of use, the sermorelin provided is “compounded in the USA” by licensed pharmacies using “FDA-registered facilities” and is subject to “3rd party lab testing.”

This means:

  • The active ingredient (sermorelin acetate) is sourced from FDA-registered facilities
  • The finished compounded product is not FDA-approved
  • Quality testing is performed but is not FDA-mandated to the same degree as approved drugs

Off-Label Prescribing for Wellness and Fitness

As discussed above, current sermorelin access typically occurs via pharmacy compounding for adult wellness and fitness applications. Use in adults for wellness, anti-aging, fitness, or body composition purposes represents off-label prescribing.

Off-label prescribing is:

  • Legal and common in medical practice
  • Decided by individual providers based on medical judgment
  • Not subject to FDA marketing restrictions that apply to manufacturers
  • Not necessarily supported by the same level of clinical evidence as on-label uses

Healthcare providers have the authority to prescribe FDA-recognized compounds for indications beyond their approved uses when they judge it medically appropriate. However, this also means:

  • The specific use (adult fitness/wellness) has not undergone FDA approval processes
  • Marketing claims about these uses are restricted
  • Clinical evidence supporting off-label uses may be limited
  • Individual providers bear responsibility for determining appropriateness

Regulatory Scrutiny in the Peptide Therapy Industry

The FDA has issued warnings to various compounding pharmacies and peptide therapy providers over the years regarding:

  • Unapproved marketing claims
  • Quality control issues
  • Distribution of bulk peptides to non-licensed entities
  • Safety concerns with specific peptide compounds

Readers should review the most current information about any platform’s compliance, quality controls, and regulatory standing before proceeding. This is particularly important in the peptide therapy space given ongoing regulatory developments.

What This Means for You

If you’re considering sermorelin therapy through ReadyRx or any other platform:

  • Understand you’re receiving a compounded medication, not an FDA-approved drug
  • The prescribing provider is making an off-label determination of appropriateness
  • Quality controls rely on pharmacy practices and third-party testing rather than FDA approval processes
  • The regulatory landscape may continue evolving, potentially affecting availability or requirements

These are not reasons to avoid sermorelin therapy categorically—many individuals use compounded peptides successfully under medical supervision. However, informed consent requires understanding what “compounded” means and how it differs from FDA-approved medications.

Contact Information

For questions about ReadyRx sermorelin therapy, according to the company’s website:

Email: support@readyrx.com
Platform: Available at www.readyrx.com and www.getreadyrx.com

According to the terms of use, the company is operated by Executive Medical, LLC, with a mailing address at 1712 Pioneer Ave Ste #115, Cheyenne, WY, 82001.

For clinical questions about your treatment, the platform provides “unlimited physician messaging” to affiliated providers. For billing, subscription management, or platform-related questions, contact the support email above.

View the current Sermorelin Rx offer (official ReadyRx page)

Final Verdict: Matching Realistic Expectations to Peptide Therapy in 2026

The search phrase “best peptides for muscle growth” reflects an understandable desire to optimize body composition, recovery, and training results. Sermorelin, as one of the more established prescription peptide options available through platforms like ReadyRx, offers a medically supervised approach to growth hormone optimization—but with realistic timelines, individual variability, and modest effects compared to the dramatic claims often seen on social media.

The Case for ReadyRx Sermorelin

For individuals who have already optimized training, nutrition, and sleep but feel they’ve reached a plateau, sermorelin therapy may provide incremental benefits when prescribed by an independent clinician:

  • Accessible formats: Both injectable and needle-free dissolving-tablet options are available according to the company. Confirm current format availability on the official page.
  • Competitive pricing: ReadyRx’s subscription structure is presented as competitive within the telehealth peptide market. Confirm current pricing on the official page before making comparisons.
  • Medical oversight: Prescription requirement ensures evaluation by licensed providers rather than direct-to-consumer unregulated peptide sales.
  • Bundled support: Inclusion of personalized protocols, meal planning, and coaching may help users optimize lifestyle factors that influence peptide therapy response.
  • Quality controls: Third-party lab testing for potency, sterility, pH, and endotoxicity provides accountability beyond what unregulated peptide sources offer.

For people who understand that benefits develop gradually over months, accept that individual response varies widely, and can sustainably afford ongoing costs, sermorelin therapy represents a legitimate option worth discussing with the prescribing providers. Prescription approval is not guaranteed.

Considerations to Weigh

Equally important are the limitations and realistic expectations:

  • Modest effects: Sermorelin is not a rapid muscle-building compound. Changes occur gradually and may be subtle even after several months of consistent use.
  • Individual variability: Not everyone responds significantly. Age, baseline hormone levels, lifestyle factors, and genetics all influence outcomes.
  • Ongoing costs: ReadyRx presents sermorelin as a subscription-based program with pricing shown during eligibility and checkout. Benefits described in clinical contexts typically require 6-12 months of consistent use to fully develop, meaning substantial financial commitment before determining effectiveness. Confirm current pricing on the official page to evaluate long-term affordability.
  • Compounded medication status: Compounded sermorelin has not undergone FDA review as a finished product. The FDA does not verify its safety, effectiveness, or quality before it is marketed. Quality assurance relies on pharmacy practices and third-party testing.
  • Time commitment: Peptide therapy is measured in months, not weeks. Individuals looking for rapid results will be disappointed.
  • No guarantees: The prescribing provider may determine you’re not an appropriate candidate. Prescription approval is not guaranteed. Response is not guaranteed, and benefits vary widely.

Regulatory Scrutiny Note

Important Note: The peptide therapy industry has been under increased regulatory scrutiny in recent years. Readers should review the most current information about any platform’s compliance, quality controls, and regulatory standing before starting treatment. Regulatory requirements may continue evolving, potentially affecting product availability or oversight standards.

Who Should Pursue a Consultation

Sermorelin therapy through ReadyRx may be worth exploring if you:

  • Have optimized training, nutrition, and sleep fundamentals
  • Are at least 25 years old with realistic body composition goals
  • Can sustainably afford subscription-based peptide therapy (confirm current pricing on the official page)
  • Value sleep quality and recovery improvements even if muscle growth is modest
  • Prefer prescription-based medical oversight to unregulated peptide sources
  • Are patient enough to allow cumulative effects to develop over months
  • Understand this is a complement to training and nutrition, not a replacement
  • Understand prescription approval is not guaranteed

Who Should Focus on Fundamentals First

Other approaches will provide greater value if you:

  • Have suboptimal training program design or nutrition protocols
  • Expect dramatic rapid muscle growth
  • Have limited budgets where $185/month represents significant strain
  • Are under 25 with normal hormone function
  • Have health contraindications (active cancer, uncontrolled diabetes, etc.)

For most people, optimizing training stimulus, protein intake, sleep consistency, and stress management will produce more dramatic improvements than any peptide therapy. Sermorelin makes the most sense for individuals who have already addressed these fundamentals and are seeking marginal optimization.

The Bottom Line

ReadyRx provides accessible, medically supervised sermorelin therapy in both injectable and dissolving-tablet formats with a subscription structure that is competitive within the telehealth peptide market (confirm current pricing on the official page). For individuals with realistic expectations, optimized fundamentals, and sustainable budgets, it represents a legitimate option for exploring growth hormone optimization heading into 2026.

However, peptide therapy is not magic. It requires patience, consistency, realistic expectations, and understanding that individual response varies widely. Prescription approval is not guaranteed. The gap between social media peptide hype and actual clinical outcomes is significant—going in with eyes open about what sermorelin can and cannot do is essential for avoiding disappointment.

For anyone considering this path, start by ensuring your training, nutrition, sleep, and stress management are genuinely optimized. If you’re already doing everything right and looking for that final 5-10% of optimization, a consultation with one of ReadyRx’s affiliated providers to determine if you’re an appropriate candidate may be worthwhile. But if fundamentals are not yet dialed in, addressing those factors first will provide far greater returns.

View the current Sermorelin Rx offer (official ReadyRx page)

Disclaimer

Content and Medical Disclaimer: This article is for informational purposes only and is not a substitute for professional medical advice, diagnosis, or treatment. The descriptions of potential benefits are not guarantees and are not a substitute for an individualized medical evaluation. Sermorelin is a compounded prescription medication that requires evaluation by a licensed clinician. The information provided here does not replace the professional judgment of your healthcare provider.

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

Compounded Medication Notice: Sermorelin provided through ReadyRx is a compounded prescription medication prepared by a licensed pharmacy based on an individual prescription. Compounded medications are not reviewed or approved by the FDA as finished products. The FDA does not verify their safety, effectiveness, or quality before they are marketed. They are prepared using active ingredients sourced from FDA-registered facilities under the direction of a prescribing clinician.

Platform and Provider Separation: ReadyRx is not itself a healthcare provider. Independent medical providers review your case and determine whether treatment is appropriate for you. ReadyRx provides the technology infrastructure, customer service, and coordination that enables the telehealth experience. Licensed medical providers make all clinical decisions. Partner pharmacies fulfill prescriptions written by the medical providers. This three-entity structure is common across telehealth platforms and ensures appropriate separation between the technology platform, clinical decision-making, and medication dispensing.

Results May Vary: Individual results will vary based on factors including age, baseline hormone levels, body composition, training status, nutrition quality, sleep consistency, stress levels, genetic factors, current medications, and other individual variables. While some users report improvements in sleep quality, recovery, and body composition, results are not guaranteed. Ingredient-level research on sermorelin and growth hormone secretagogues does not guarantee individual outcomes with compounded sermorelin products.

Off-Label Use Framing: Sermorelin acetate previously appeared in an FDA-approved branded product (Geref) used in pediatric growth hormone deficiency contexts; that product was later discontinued and listed by FDA as discontinued for reasons other than safety or effectiveness. Many modern programs provide sermorelin via pharmacy compounding, and compounded medications are not FDA-approved as finished products. Use in adults for wellness, fitness, anti-aging, or body composition purposes represents off-label prescribing. Off-label prescribing is legal and common in medical practice when providers determine it is medically appropriate, but means the specific application has not undergone FDA approval processes for that indication. Prescription approval is not guaranteed.

FTC Affiliate Disclosure: This article contains affiliate links. If you purchase through these links, a commission may be earned at no additional cost to you. This compensation does not influence the accuracy, neutrality, or integrity of the information presented. All opinions and descriptions are based on publicly available information from ReadyRx and general medical knowledge about peptide therapy.

Pricing Disclaimer: All prices, subscription terms, and promotional offers mentioned were based on information discussed in this article (December 2025) but are subject to change without notice. ReadyRx presents pricing during the eligibility and checkout flow. Always verify current pricing, subscription terms, and product availability on the official ReadyRx website before making purchasing decisions.

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

Insurance Coverage Note: Many direct-to-consumer prescription products are not covered by traditional insurance plans, but coverage policies vary. According to ReadyRx’s terms, the platform does not participate in Medicare, Medicaid, or private insurance programs. Always confirm benefits directly with your insurer. Some HSA/FSA plans may reimburse qualifying expenses; check your specific plan rules and verify eligibility with your plan administrator.

Regulatory Scrutiny Acknowledgment: The peptide therapy industry, including compounded sermorelin products, has been under increased regulatory scrutiny in recent years. Readers should review the most current information about ReadyRx’s compliance, quality controls, and regulatory standing before starting treatment. Regulatory requirements may continue evolving, potentially affecting product availability, oversight standards, or distribution practices.

Legal Compliance Reminder: This article provides educational information about a prescription medication available through a licensed telehealth platform. Sermorelin is a prescription-only medication requiring a valid prescription from a licensed healthcare provider. Prescription approval is not guaranteed. It is illegal to obtain sermorelin without a prescription or from unlicensed sources. Always verify that any platform you use operates in compliance with applicable federal and state regulations.

Copyright © 2025. All rights reserved. This article was published December 2025 and reflects information current as of that date.

CONTACT: Email: support@readyrx.com

U.S. FDA Approves Agios’ AQVESME™ (mitapivat) for the Treatment of Anemia in Adults with Alpha- or Beta-Thalassemia

U.S. FDA Approves Agios’ AQVESME™ (mitapivat) for the Treatment of Anemia in Adults with Alpha- or Beta-Thalassemia




U.S. FDA Approves Agios’ AQVESME™ (mitapivat) for the Treatment of Anemia in Adults with Alpha- or Beta-Thalassemia

  • AQVESME is the only FDA-approved medicine for anemia in both non-transfusion-dependent and transfusion-dependent alpha- or beta-thalassemia
  • Marketed under AQVESME brand name in the U.S. for thalassemia indication; PYRUKYND® (mitapivat) remains the U.S. brand name for PK deficiency indication 
  • AQVESME expected to be available in late January 2026, following AQVESME REMS program implementation
  • Company will host investor conference call and webcast tomorrow, December 24 at 8:00 a.m. ET

CAMBRIDGE, Mass., Dec. 23, 2025 (GLOBE NEWSWIRE) — Agios Pharmaceuticals, Inc. (Nasdaq: AGIO), a commercial-stage biopharmaceutical company focused on delivering innovative medicines for patients with rare diseases, today announced that the U.S. Food and Drug Administration (FDA) has approved AQVESME™ (mitapivat), an oral pyruvate kinase (PK) activator, for the treatment of anemia in adults with alpha- or beta-thalassemia. With this approved indication, AQVESME becomes the only FDA-approved medicine for anemia in both non-transfusion-dependent and transfusion-dependent alpha- or beta-thalassemia.

“Thalassemia is a debilitating disease that demands lifelong management and vigilant monitoring for many life-threatening complications, such as blood clots, heart disease, and liver disease. Despite its severity, treatments have historically been limited, leaving some patients without any options,” said Hanny Al-Samkari, M.D., Peggy S. Blitz Endowed Chair in Hematology/Oncology at Mass General Brigham Cancer Institute, Associate Professor at Harvard Medical School, and an investigator for the mitapivat thalassemia Phase 3 clinical program. “The ENERGIZE and ENERGIZE-T Phase 3 trial results demonstrate that AQVESME can help address anemia, fatigue, and the need for regular transfusions – key challenges of the disease. Today’s FDA approval represents an important step forward for individuals with thalassemia.”

The FDA approval of AQVESME in thalassemia is based on results from the global, randomized, double-blind, placebo-controlled ENERGIZE and ENERGIZE-T Phase 3 trials in adults with non-transfusion-dependent and transfusion-dependent alpha- or beta-thalassemia, respectively. A total of 452 patients who are representative of the real-world thalassemia population were enrolled in the trials. The ENERGIZE and ENERGIZE-T Phase 3 trials met all primary and key secondary efficacy endpoints, demonstrating that AQVESME improves hemolytic anemia and a key quality-of-life measure compared to placebo, including significant reductions in transfusion burden and significant improvements in hemoglobin and fatigue.

“Today is a landmark moment for the thalassemia community, bringing forward an innovative, disease-modifying oral medicine to address the urgent needs of people living with this devastating rare blood disorder,” said Brian Goff, Chief Executive Officer, Agios. “With this approval, AQVESME becomes the only medicine indicated for the treatment of anemia in both non-transfusion-dependent and transfusion-dependent alpha- or beta-thalassemia. We are deeply grateful to the patients, caregivers, healthcare providers, and advocacy partners who participated in and supported our clinical trials and helped ensure that our efforts reflected their priorities. Our focus now is on ensuring a successful launch and delivering meaningful impact for the community.”

“This year marks 100 years since thalassemia was first described in medical literature, and the progress we’ve made as a community is truly extraordinary,” said Ralph Colasanti, National President, Cooley’s Anemia Foundation. “Innovative medicines like AQVESME help make this progress possible, offering new hope to patients like me by helping to address the complex needs and challenges of this disease. This approval provides an important new treatment option for the thousands of adults living with thalassemia in the U.S., including those with non-transfusion-dependent thalassemia who previously had no approved alternatives.”

In the ENERGIZE and ENERGIZE-T Phase 3 trials, five patients receiving AQVESME experienced adverse reactions suggestive of hepatocellular injury (HCI), with two of these patients requiring hospitalization. These adverse reactions occurred within the first six months of exposure, and liver tests improved upon discontinuation of AQVESME. To mitigate the risk of HCI, AQVESME is available only through the AQVESME REMS, a Risk Evaluation and Mitigation Strategy (REMS) program approved by the FDA. The AQVESME REMS program requires liver tests prior to the first AQVESME dose, every four weeks thereafter for 24 weeks, and then as clinically indicated. It also includes education and certification requirements for patients, prescribing physicians, and pharmacists, which are common components of REMS programs.

Due to the AQVESME REMS program, mitapivat will be marketed under the brand name AQVESME in the U.S. for the thalassemia indication. Mitapivat will continue to be marketed as PYRUKYND® (mitapivat) in the U.S. for the PK deficiency indication, which does not require a REMS program. Outside the U.S., mitapivat will continue to be marketed as PYRUKYND for its PK deficiency and thalassemia indications in regions where it is approved, and will retain this name upon approval in regions currently under regulatory review.

Agios expects AQVESME to be available in the U.S. in late January 2026, following implementation of the AQVESME REMS program. For more information, visit AQVESME.com.

Conference Call Information
Agios will host a virtual investor event tomorrow, December 24, 2025, at 8:00 a.m. ET, to discuss the FDA approval of AQVESME in thalassemia. The live webcast will be accessible on the Investors section of the company’s website (www.agios.com) under the “Events & Presentations” tab. A replay of the webcast will be available on the company’s website approximately two hours after the event.

About Thalassemia
Thalassemia is a rare, inherited blood disease that affects the production of hemoglobin, the protein in red blood cells responsible for carrying oxygen throughout the body. The disease is categorized into two main types: alpha-thalassemia and beta-thalassemia, depending on which globin chain of the hemoglobin is affected. By disrupting hemoglobin production, thalassemia reduces the number of circulating red blood cells and shortens their lifespan, which leads to anemia, fatigue, and serious complications.

Some individuals with thalassemia require regular transfusions (classified as transfusion-dependent thalassemia), while others only need them intermittently (classified as non-transfusion-dependent thalassemia). All patients with thalassemia experience a significant disease burden, including comorbidities, reduced quality of life, and shortened life expectancy.  

In the U.S., approximately 6,000 adult patients are diagnosed with thalassemia.  

About ENERGIZE and ENERGIZE-T
ENERGIZE (NCT04770753) and ENERGIZE-T (NCT04770779) are global, double-blind, placebo-controlled Phase 3 trials evaluating the efficacy and safety of mitapivat in adults with alpha- or beta-thalassemia.

The ENERGIZE trial randomized 194 non-transfusion-dependent alpha- or beta-thalassemia patients 2:1 to receive either mitapivat 100 mg twice daily or placebo. The primary endpoint was hemoglobin response, defined as an increase of ≥1.0 g/dL in average hemoglobin concentration from Week 12 through Week 24 compared with baseline. Key secondary endpoints included changes from baseline in average fatigue scores and in average hemoglobin concentration from Week 12 to Week 24. The trial also assessed safety and tolerability.

The ENERGIZE-T trial randomized 258 transfusion-dependent alpha- or beta-thalassemia patients 2:1 to receive either mitapivat 100 mg twice daily or placebo. The primary endpoint was transfusion reduction response, defined as a ≥50% reduction in transfused red blood cell (RBC) units with a reduction of ≥2 units of RBCs transfused in any consecutive 12-week period through Week 48 compared with baseline. Several transfusion reduction measures were included as key secondary endpoints, and achievement of transfusion independence was a secondary endpoint. The trial also assessed safety and tolerability.

For each trial, patients who completed the double-blind phase had the option to transition into a corresponding open-label extension phase, during which all patients receive mitapivat.

About AQVESME™ (mitapivat)
U.S. INDICATION
AQVESME is indicated for the treatment of anemia in adults with alpha- or beta-thalassemia.

U.S. IMPORTANT SAFETY INFORMATION
BOXED WARNING: HEPATOCELLULAR INJURY

AQVESME can cause serious hepatocellular injury. Measure liver laboratory tests (ALT, AST, alkaline phosphatase and total bilirubin with fractionation) at baseline and every 4 weeks for 24 weeks and then as clinically indicated. Avoid use of AQVESME in patients with cirrhosis. Discontinue AQVESME if hepatic injury is suspected.

Because of the risk of hepatocellular injury, AQVESME is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the AQVESME REMS.

WARNINGS AND PRECAUTIONS

Hepatocellular Injury
AQVESME can cause hepatocellular injury. Avoid use of AQVESME in patients with cirrhosis. In patients with thalassemia treated with AQVESME, liver injury with and without jaundice has been observed within the first 6 months of exposure. Obtain liver tests (including ALT, AST, alkaline phosphatase, total bilirubin with fractionation) prior to the initiation of AQVESME, then every 4 weeks for the first 24 weeks, and as clinically indicated thereafter. Interrupt AQVESME if clinically significant increases in liver tests are observed or alanine aminotransferase is >5 times the upper limit of normal (ULN). Complete a comprehensive evaluation to rule out other causes of liver injury when drug-induced liver injury is suspected. Discontinue AQVESME if hepatocellular injury due to AQVESME is suspected.

Symptoms and signs of early liver injury may mimic those of thalassemia. Advise patients to report new or worsening symptoms of loss of appetite, nausea, right-upper-quadrant abdominal pain, vomiting, scleral icterus, jaundice, or dark urine while on AQVESME treatment.

During the double-blind period, 2 of 301 patients (0.66%) with thalassemia treated with AQVESME experienced adverse reactions suggestive of hepatocellular injury. Three additional patients experienced adverse reactions suggestive of hepatocellular injury during the open-label extension periods after switching from placebo to AQVESME. Of these 5 patients, 2 had serious liver injury requiring hospitalization, including 1 patient who developed jaundice (peak bilirubin 32 mg/dL). Another patient developed jaundice (peak bilirubin 4 mg/dL) without requiring hospitalization. These reactions were characterized by a time to onset within the first 6 months of treatment with peak elevations of alanine aminotransferase of >5×ULN with or without jaundice. All patients discontinued treatment with AQVESME, and these reactions improved upon treatment discontinuation.

AQVESME REMS
AQVESME is available only through a restricted program under a REMS called the AQVESME REMS because of the risk of hepatocellular injury.

ADVERSE REACTIONS
The most common adverse reactions (≥5%) among patients taking AQVESME were headache and insomnia.

DRUG INTERACTIONS

  • Strong CYP3A Inhibitors and Inducers: Avoid concomitant use.
  • Moderate CYP3A Inhibitors: Avoid concomitant use.
  • Moderate CYP3A Inducers: Consider alternatives that are not moderate inducers. If there are no alternatives, see full Prescribing Information for recommended dosage for drug interactions with moderate CYP3A inducers.
  • Sensitive CYP3A Substrates, including hormonal contraceptives: Avoid concomitant use with substrates that have narrow therapeutic index.
  • CYP2B6, CYP2C, and UGT1A1 Substrates: Monitor patients for efficacy of the substrates with narrow therapeutic index.
  • P-gp Substrates: Monitor patients for adverse reactions of the substrates with narrow therapeutic index.

HEPATIC IMPAIRMENT
Avoid use of AQVESME in patients with cirrhosis (Child-Pugh Class A, B, or C).

Please see full Prescribing Information for AQVESME, including Boxed Warning.

About PYRUKYND® (mitapivat)
U.S. INDICATION
PYRUKYND is a pyruvate kinase activator indicated for the treatment of hemolytic anemia in adults with pyruvate kinase (PK) deficiency.

U.S. IMPORTANT SAFETY INFORMATION
Acute Hemolysis: Acute hemolysis with subsequent anemia has been observed following abrupt interruption or discontinuation of PYRUKYND in a dose-ranging study. Avoid abruptly discontinuing PYRUKYND. Gradually taper the dose of PYRUKYND to discontinue treatment if possible. When discontinuing treatment, monitor patients for signs of acute hemolysis and anemia including jaundice, scleral icterus, dark urine, dizziness, confusion, fatigue, or shortness of breath.

Hepatocellular Injury in Another Condition: In patients with another condition treated with mitapivat at a higher dose than that recommended for patients with PK deficiency, liver injury has been observed. These events were characterized by a time to onset within the first 6 months of treatment with peak elevations of alanine aminotransferase of >5x upper limit of normal (ULN) with or without jaundice. All patients discontinued treatment with mitapivat, and these events improved upon treatment discontinuation.

Obtain liver tests prior to the initiation of PYRUKYND and monthly thereafter for the first 6 months and as clinically indicated. Interrupt PYRUKYND if clinically significant increases in liver tests are observed or alanine aminotransferase is >5x ULN. Discontinue PYRUKYND if hepatic injury due to PYRUKYND is suspected.

Adverse Reactions: The most common adverse reactions including laboratory abnormalities (≥10%) in patients with PK deficiency were estrone decreased (males), increased urate, back pain, estradiol decreased (males), and arthralgia.

Drug Interactions:

  • Strong CYP3A Inhibitors and Inducers: Avoid concomitant use.
  • Moderate CYP3A Inhibitors: Do not titrate PYRUKYND beyond 20 mg twice daily.
  • Moderate CYP3A Inducers: Consider alternatives that are not moderate inducers. If there are no alternatives, adjust PYRUKYND dosage.
  • Sensitive CYP3A, CYP2B6, CYP2C Substrates Including Hormonal Contraceptives: Avoid concomitant use with substrates that have narrow therapeutic index.
  • UGT1A1 Substrates: Avoid concomitant use with substrates that have narrow therapeutic index.
  • P-gp Substrates: Avoid concomitant use with substrates that have narrow therapeutic index.

Hepatic Impairment: Avoid use of PYRUKYND in patients with moderate and severe hepatic impairment.

Please see full Prescribing Information for PYRUKYND.

About Agios: Fueled by Connections to Transform Rare Diseases™
At Agios, our vision is to redefine the future of rare disease treatment. Fueled by connections, we build trusted partnerships with communities – collaborating to develop and deliver innovative medicines that have the potential to transform lives. With a foundation in hematology, we combine biological expertise with real-world insights to advance a growing pipeline of rare disease medicines that reflect the priorities of the people we serve. Agios is a commercial-stage biopharmaceutical company headquartered in Cambridge, Massachusetts. To learn more, visit www.agios.com and follow us on LinkedIn and X.

Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Such forward-looking statements include those regarding the potential benefits of Agios’ products, including AQVESME™, and its strategic plans and focus. The words “anticipate,” “expect,” “goal,” “hope,” “milestone,” “plan,” “potential,” “possible,” “strategy,” “will,” “vision,” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Such statements are subject to numerous important factors, risks and uncertainties that may cause actual events or results to differ materially from Agios’ current expectations and beliefs. For example, there can be no guarantee that any product candidate Agios is developing will successfully commence or complete necessary preclinical and clinical development phases, or that development of any of Agios’ product candidates will successfully continue. There can be no guarantee that any positive developments in Agios’ business will result in stock price appreciation. Management’s expectations and, therefore, any forward-looking statements in this press release could also be affected by risks and uncertainties relating to a number of other important factors, including, without limitation: the content and timing of decisions made by the U.S. FDA, the EMA or other regulatory authorities, investigational review boards at clinical trial sites and publication review bodies; Agios’ results of clinical trials and preclinical studies, including subsequent analysis of existing data and new data received from ongoing and future studies; risks and uncertainties related to the impact of pandemics or other public health emergencies to Agios’ business, operations, strategy, goals and anticipated milestones, including its ongoing and planned research activities, ability to conduct ongoing and planned clinical trials, clinical supply of current or future drug candidates, commercial supply of current or future approved products, and launching, marketing and selling current or future approved products; Agios’ ability to obtain and maintain requisite regulatory approvals and to enroll patients in its planned clinical trials; unplanned cash requirements and expenditures; competitive factors; Agios’ ability to obtain, maintain and enforce patent and other intellectual property protection for any product candidates it is developing; Agios’ ability to establish and maintain key collaborations; uncertainty regarding any royalty payments related to the sale of its oncology business or any milestone or royalty payments related to its in-licensing of AG-236, and the uncertainty of the timing of any such payments; uncertainty of the results and effectiveness of the use of Agios’ cash and cash equivalents; and general economic and market conditions. These and other risks are described in greater detail under the caption “Risk Factors” included in Agios’ public filings with the Securities and Exchange Commission. Any forward-looking statements contained in this press release speak only as of the date hereof, and Agios expressly disclaims any obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law. 

Contacts:

Investor Contact
Morgan Sanford, Vice President, Investor Relations
Agios Pharmaceuticals
morgan.sanford@agios.com

Media Contact
Eamonn Nolan, Senior Director, Corporate Communications
Agios Pharmaceuticals
eamonn.nolan@agios.com