FDA Panel Recommends Four Peptides for Inclusion on Compounding List
An FDA advisory panel narrowly recommended four peptides—BPC-157, KPV, TB-500, and MOTS-C—for inclusion on the federal 503A Bulks List. The vote was split among committee members, with some supporting despite concerns raised by FDA staff scientists about safety, formulation clarity, and human evidence. This recommendation could allow compounding pharmacies to legally produce these peptides, potentially opening new market opportunities. Hims & Hers Health Inc., which recently acquired a peptide manufacturing facility in California, stands to benefit if the peptides gain regulatory approval. Analysts at Leerink Partners called this development a positive catalyst for Hims and estimated it could capture 20% of an anticipated $2.2 billion annual telehealth market tied to these peptides. The advisory panel's decision is not final; the FDA will make its own determination on whether to add the peptides to the list.
Tickers: $HIMS
Topics: compounding pharmacies FDA advisory panel Hims & Hers Health Inc. peptides