Hims & Hers Health (NYSE: HIMS) shares climbed on Thursday after an FDA advisory panel voted 8 to 6, with one abstention, in favor of adding BPC-157 to the 503A compounding list. The decision has shifted investor focus toward the company's potential to boost revenue per subscriber through peptide-based treatments.
Shares of the telehealth company rose 6.4% to $33.72 as of 1:56 p.m. EDT, after earlier surging more than 10%. The initial equity value increase of approximately $470 million corresponded to roughly 77% of Hims' first-quarter revenue of $608.1 million, and 9.6 times its U.S. revenue decline of $48.8 million during the same period.
The panel's recommendation does not carry binding authority. The FDA must still decide whether to update the 503A list, a process that a former agency official told Reuters could take up to a year. Inclusion would not constitute full approval for BPC-157; that would require individual clinical trials and a formal regulatory review.
Hims has not announced a launch date for any BPC-157 product. However, the company has been preparing for regulatory shifts since acquiring a manufacturing site in 2025, where it has begun developing peptide treatments. Chief Medical Officer Anant Vinjamoori said regulated supply could replace gray-market transactions, but noted that a negative vote would not have ended those distribution channels.
Analysts have projected a peptide market ranging from $2.2 billion (Michael Cherny) to $3.3 billion (Needham & Co.), representing 21% and 14% of the $470 million equity gain, respectively. These figures serve as measures of scale rather than profit predictions, indicating that investors expect peptides to drive increased spending among current users.
Hims reported 2.58 million subscribers at the end of March, a 9% increase year-over-year, but average monthly revenue per subscriber declined 6% to $80. U.S. revenue fell 8% to $529.9 million, while international sales helped lift total revenue by 4%.
FDA staff had advised against approval, citing a single limited ulcerative colitis study and insufficient long-term safety data. The panel's agenda also includes discussions on KPV, TB-500, and MOTS-C on Thursday, with Emideltide, Semax, and Epitalon scheduled for Friday.
Options data ahead of the vote suggested a 14% swing in either direction by month-end, highlighting elevated risks. The timeline for FDA decisions and patient uptake remains uncertain, and safety data is limited. U.S. markets were trading at the dateline, with the NYSE main session closing at 4 p.m. EDT.
