FDA Panel Narrowly Backs Four Peptides — Hims & Hers Stock in the Spotlight

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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.

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 and unresolved safety concerns including immune reactions and contamination risk.

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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.

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.

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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.

Shares jumped more than 10% intraday Thursday following the initial BPC-157 vote before paring gains to close up roughly 3% at $32.74.

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