Hims & Hers: FDA’s initial recommendation tempers peptide opportunity

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Hims & Hers: FDA’s initial recommendation tempers peptide opportunity

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Hims & Hers

FDA’s initial recommendation tempers

peptide opportunity

Reiterate Rating: NEUTRAL | PO: 36.00 USD | Price: 34.67 USD

FDA recommends not adding 7 peptides to the bulk list 01 July 2026

Earlier this week, the FDA released briefing materials ahead of the July 23–24 Pharmacy Equity

Compounding Advisory Committee (PCAC) meeting reviewing the 7 peptides planned for

discussion and recommended these peptides not be included on the 503A Bulk List. Key Changes

These conclusions appear to be preliminary and the PCAC meetings remain scheduled

for July 23rd and 24th. The FDA does not intend to issue a final determination on the (US$) Previous Current

issues at hand until input from the advisory committee process has been considered and Price Obj. 25.00 36.00

all reviews have been finalized. The briefing material notes that the final determination

may be affected by issues not discussed at the advisory committee meeting. The FDA AllenResearchLutz,AnalystCFA

cited key concerns centered on limited clinical evidence, unresolved safety/quality BofAS

+1 646 855 4380

questions, and insufficient support for the proposed use cases. The 7 peptides reviewed allen.lutz@bofa.com

include: BPC-157 for ulcerative colitis, KPV for wound healing/inflammatory conditions, Dev Weerasuriya

TB-500 for wound healing, MOTs-C for obesity/osteoporosis, Emideltide/DSIP for opioid Research Analyst

BofAS

withdrawal/chronic insomnia/narcolepsy, Semax for cerebral +1 646 855 5707

ischemia/migraine/trigeminal neuralgia, and Epitalon for insomnia. We note that under dev.weerasuriya@bofa.com

the 503A framework, inclusion on the 503A Bulk List is the pathway that would allow Hanna Lee

Research Analyst