DataMEDS AI Announces Corexa Pharmacy's First Commercial Sale of Compounded Peptides Under FDA Enforcement Discretion Policy

Corexa is working through pricing and intends to market its compounded-peptide offering to prescribing physicians.

Rhea-AI Summary

DataMEDS AI (MEDS) announced that its Corexa Pharmacy subsidiary completed its first commercial sale of a compounded peptide under an enforcement discretion policy. The sale involved one of six peptides recommended by the FDA's Pharmacy Compounding Advisory Committee at its July 23–24, 2026 meeting: BPC-157, TB-500, KPV, MOTS-c, Epitalon and Semax. The sale was made under the U.S. Department of Health and Human Services' Enforcement Discretion Policy. These compounded drugs are not FDA-approved and have not been evaluated by FDA for safety or efficacy.

The company intends to use its pharmacy hub and distribution warehouse capabilities and begin actively marketing the offering soon, while it works through pricing. Marketing will target prescribing physicians; compounded medications are prescribed individually for each patient.

Positive

• Minor pointCorexa Pharmacy completed its first commercial sale of one of the six compounded peptides.
• Minor point. Forward-looking: it has not happened yet and may not happen.DataMEDS intends to deploy pharmacy hub and distribution warehouse capabilities and begin physician-focused marketing soon.

Negative

• None.

Key Figures

Peptides in group: 6 peptides

Peptides in group

6 peptides

FDA PCAC-recommended group; the first sale covered one peptide

Key Terms

compounded drugs, enforcement discretion policy, smart contracts

3 terms

compounded drugs medical

"The Six Peptides are compounded drugs, are not FDA-approved"

Medications prepared by a pharmacist to fit a specific patient’s needs by mixing, altering, or combining ingredients when a ready-made product isn’t suitable—think of a tailor altering a garment to fit one person. For investors, compounded drugs matter because they create niche demand and revenue for specialty pharmacies but also carry higher regulatory, quality and liability risk, which can affect costs, reputations and reimbursement prospects across the supply chain.

enforcement discretion policy regulatory

"in accordance with U.S. Health and Human Services' Enforcement Discretion Policy"

A policy by a regulator, exchange, or enforcement agency to exercise judgment in applying or temporarily refraining from applying specific legal or regulatory requirements; it describes circumstances, factors, or conditions under which enforcement actions will be prioritized, delayed, limited, or not pursued. Such a policy does not change the underlying law or rule, is applied case-by-case (often with stated criteria and time limits), and can be revoked or modified at the agency's discretion, so it does not create a guaranteed legal right or permanent waiver.

smart contracts technical

"blockchain-enabled smart contracts platform"

Self-executing digital agreements whose terms are written as code and stored on a distributed ledger so they run automatically when preset conditions are met — like a vending machine that releases a snack only after you insert the right coins. Investors care because smart contracts can speed up transactions, cut middlemen, reduce errors and fraud, and create new ways to issue, trade or enforce financial assets, which affects costs, risk and regulatory oversight.

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TAMPA, FL / ACCESS Newswire / November 9, 2026 / DataMeds AI, Inc. ("DataMeds SI," "DataMEDS" or the "Company") (NASDAQ:MEDS), a healthcare company that integrates its health information technology and physical infrastructure with its EinsteinRx™ artificial intelligence platform and PharmacyChain™ blockchain-enabled smart contracts platform, today announced that its Corexa Pharmacy subsidiary has completed its first commercial sale of one of the six peptides (BPC-157, TB-500, KPV, MOTS-c, Epitalon and Semax, together the "Six Peptides") recommended by the U.S. Food and Drug Administration's (FDA) Pharmacy Compounding Advisory Committee (PCAC) at its July 23-24, 2026 meeting, in accordance with U.S. Health and Human Services' (HHS) Enforcement Discretion Policy (EDP). The Six Peptides are compounded drugs, are not FDA-approved and have not been evaluated by FDA for safety or efficacy.

"Corexa Pharmacy has worked through the mechanics of dispensing the Six Peptides in compliance with HHS' recently published Enforcement Discretion Policy," said Gerald Commissiong, Interim Co-CEO of DataMEDS. "Now that we have confirmed our ability to dispense the Six Peptides in compliance with recent guidelines in this burgeoning field, we intend to bring our pharmacy hub and distribution warehouse capabilities to the fore to take full advantage of the opportunity. We are currently working through the pricing model and intend to begin actively marketing our offering in a compliant fashion in the very near future. It is crucial to remember that compounded medications are prescribed on a one-to-one basis for individual patients. As such, our marketing will focus on reaching the physicians who prescribe these medications and are able to provide the appropriate oversight, in line with recent guidelines."

The U.S. compounding pharmacy market is expected to grow from $18.02 billion in 2025 to over $31.77 billion by 2034, according to Precedence Research.

About DataMEDS AI

DataMEDS AI, Inc. (NASDAQ:MEDS), formerly Wellgistics Health, Inc., is a healthcare company focused on the vertical integration of technology, pharmacy, pharmaceutical-adjacent and telemedicine business units through its health information technology platforms to deliver a better experience for consumers and providers. Headquartered in Tampa, Fla., DataMEDS incorporates its EinsteinRx™ artificial intelligence platform and PharmacyChain™ blockchain-enabled smart contracts platform into the Health Lives Here mobile application from Tollo Health, LLC, and its pharmacy-related Corexa Health subsidiary provides pharmacy dispensing and pharmacy-related services, including distribution of products developed by Tollo Health. DataMEDS also owns Helomics Corporation, a Pittsburgh, PA-based commercial clinical molecular diagnostics laboratory focused on the ChemoFx® Assay chemotherapy selection diagnostics test that aims to help oncologists make chemotherapy treatment decisions. Learn more at https://datamedsai.com.

About Tollo Health

Tollo Health, LLC is a healthcare company commercializing proprietary medical foods and dietary supplements and, through TolloBio, developing biopharmaceutical candidates, alongside its Health Lives Here mobile application. Corexa Health, a subsidiary of DataMeds AI, Inc., distributes select Tollo Health medical foods and dietary supplements under a wholesale distribution arrangement.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements are based on management's current expectations and are not predictions of actual performance. Forward-looking statements include, without limitation, statements regarding: Corexa Pharmacy's ability to compound, dispense and distribute the Six Peptides in compliance with FDA's enforcement discretion policy, Section 503A of the Federal Food, Drug, and Cosmetic Act and state pharmacy laws; the possibility that FDA or HHS may change or withdraw the enforcement discretion policy, and FDA's final decisions regarding the 503A bulks list; the Company's pricing model and the timing and compliance of its marketing to prescribing physicians; physician prescribing demand and market acceptance of compounded peptides; reliance on third-party suppliers and partner pharmacies, and the quality and availability of bulk drug substances; sterile compounding compliance, adverse events and product liability; the Company's plans for its pharmacy hub and distribution warehouse, including required licensure; competition from other compounding pharmacies and from unregulated research-use-only products; the accuracy of third-party market size estimates; related-party arrangements with Tollo Health, LLC; the Company's ability to maintain compliance with Nasdaq listing standards; and the Company's liquidity, capital resources and ability to fund operations. Actual results may differ materially from those expressed or implied in these forward-looking statements due to a number of risks and uncertainties, including those described under "Risk Factors" in the Company's most recent Annual Report on Form 10-K and subsequent filings with the Securities and Exchange Commission. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. The Company undertakes no obligation to update or revise any forward-looking statements, except as required by law.

DataMEDS AI Media Contact
James Lambert, Vice President, Rubenstein Public Relations
212.805.3024 | jlambert@rubensteinpr.com

DataMEDS AI Investor Contact
IR@datamedsai.com

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SOURCE: DataMEDS AI, Inc.

View the original press release on ACCESS Newswire

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

What did DataMEDS AI's Corexa Pharmacy sell in its first compounded-peptide commercial sale?

Corexa Pharmacy completed its first commercial sale of one of six compounded peptides: BPC-157, TB-500, KPV, MOTS-c, Epitalon and Semax. The six were recommended by the FDA's Pharmacy Compounding Advisory Committee at its July 23–24, 2026 meeting.

Are the compounded peptides sold by DataMEDS AI's Corexa Pharmacy FDA-approved?

The six compounded peptides are not FDA-approved and have not been evaluated by FDA for safety or efficacy. Corexa's first commercial sale was made under the U.S. Department of Health and Human Services' Enforcement Discretion Policy.