Hims & Hers Health stock surged roughly 10% on July 23 after an FDA advisory panel voted to recommend that the peptide BPC-157 be added to the federal 503A Bulk Drug Substances List, a move that would allow compounding pharmacies to legally produce the compound.
The Pharmacy Compounding Advisory Committee (PCAC) voted 8-6 in favor of the recommendation, with one abstention, according to Investing.com and multiple news outlets. The close vote reflects divided opinion among committee members about the peptide’s wider availability, though the recommendation still requires final FDA approval to take effect.
BPC-157 is a short peptide that has gained popularity online for claims of healing injuries and reducing inflammation, though its use remains controversial. According to CBS News, the compound has only been tested in about 30 humans, a fraction of the testing done for approved therapies like GLP-1 medications, which were tested on hundreds of thousands of patients.
The committee’s recommendation came despite FDA staff scientists recommending against reclassification. The FDA’s own scientists cited insufficient clinical evidence, unresolved safety questions, and lack of rigorous testing as reasons to keep restrictions in place, according to Benzinga reporting on FDA briefing materials.
Hims’ chief medical officer, Anant Vinjamoori, testified at the hearing in support of the reclassification. Hims has positioned itself as a leading platform for peptide access, and the company stands to benefit significantly if the FDA approves peptides for compounding pharmacies. Vinjamoori argued for “a responsible way forward — one where patients stay under a clinician’s care, where that care is monitored and studied.”
The committee’s composition itself shifted before the vote. According to Yahoo Finance reporting, the FDA added eight new committee members deemed “more qualified and less conflicted,” which analysts noted could influence the outcome. This change reflected broader political pressure surrounding peptide regulation, as Health and Human Services Secretary Robert F. Kennedy Jr. has publicly stated he is a “big fan” of unapproved peptides.
Wall Street analysts remain cautiously optimistic. BofA Securities raised its Hims price target to $36 from $25 in early July, while Canaccord Genuity maintains a Buy rating with a $40 price target, according to Benzinga. However, both firms note that the advisory vote is not binding and that the final regulatory outcome remains uncertain.
The FDA will continue to review the panel’s recommendation before making a final determination on whether BPC-157 and six other peptides under consideration can be added to the 503A list. If approved, the reclassification would allow state-licensed compounding pharmacies to legally produce the compounds for patients with valid prescriptions, moving the peptides from the gray market into a regulated framework.
Sources
- Investing.com — FDA panel vote on BPC-157 (8-6 with one abstention), Hims stock movement, and non-binding nature of recommendation
- MarketWatch — Detailed breakdown of all seven peptides under review, FDA staff recommendation against reclassification, Hims CMO testimony, and analyst commentary on the vote’s significance
- CBS News — BPC-157 human testing data (30 patients), FDA staff position, safety concerns, and broader context on unapproved peptides
- Benzinga — Stock price movement, FDA briefing materials and preliminary recommendation, analyst ratings and price targets (BofA $36, Canaccord $40), and technical analysis
- Yahoo Finance — Committee composition changes with eight new members added before the vote
