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FinanceFDA Panel Votes 8-6 to Recommend Four Peptides for 503A Bulks List; Hims & Hers Stock Closes Up 3%
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An FDA advisory committee voted 8-6 (with one abstention) to recommend adding peptides BPC-157, KPV, and TB-500 to the 503A Bulks List, and separately voted 7-5-2 to recommend MOTS-C. The votes broke with FDA staff scientists who had recommended against all seven peptides under review due to weak human evidence and safety concerns. Hims & Hers Health Inc., which acquired a peptide manufacturing facility in early 2025, saw its stock jump over 10% intraday before closing up 3% at $32.74. Leerink Partners estimated the peptides could create a $2.2 billion annual telehealth market, with Hims potentially capturing 20%. The FDA will make a final determination, and the committee continues reviewing three remaining peptides.
Source report
Dylan Berman Sat, July 25, 2026 at 3:01 AM PDT | 5 min read
Hims & Hers Health Inc. is in the spotlight Friday after an FDA advisory panel voted Thursday to recommend four key peptides be added to a federal list that would allow compounding pharmacies to legally produce them.
FDA Panel Splits, Recommends Peptides for 503A List
The FDA's Pharmacy Compounding Advisory Committee voted 8-6, with one abstention, to recommend that BPC-157, KPV, and TB-500 each be added to the 503A Bulks List. A fourth peptide, MOTS-C, was voted on separately and received a narrower 7-5-2 tally in favor.
The divided votes broke with FDA staff scientists, who had recommended against all seven peptides under review, citing:
- Weak human evidence
- Unclear formulations
- Unresolved safety concerns, including immune reactions and contamination risk
Note: The vote is only an advisory recommendation, not final FDA approval. The agency will still need to make its own determination on whether to formally add the peptides to the list.
The committee meets again today to consider the remaining three peptides under review: Emideltide, Semax, and Epitalon.
Why It Matters for Hims
Hims acquired a California peptide manufacturing facility in early 2025 as part of its push into metabolic health, recovery, and preventive care — positioning the company to benefit if the peptides gain a clearer regulatory pathway.
Leerink Partners called the outcome a "positive catalyst" for Hims, estimating the peptides under review could create a $2.2 billion annual telehealth market, with Hims potentially capturing about 20% of that opportunity. Still, Leerink maintained a Market Perform rating and $25 price target on the stock, citing uncertainty around Hims' ability to build and scale a new peptide platform.
Hims & Hers Chief Medical Officer Dr. Anant Vinjamoori testified before the committee Wednesday, highlighting consumer demand for safer access to peptides currently sold through unregulated channels.
Thursday's Price Action
Shares jumped more than 10% intraday Thursday following the initial BPC-157 vote before paring gains to close up roughly 3% at $32.74.
Image via Shutterstock
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FDA Panel Narrowly Backs Four Peptides; Hims & Hers Stock in Focus