Hims & Hers Stock Drops After FDA Panel Rejects Emideltide Inclusion
On July 24, Hims & Hers (ticker: HIMS) stock fell sharply after an FDA advisory panel rejected the inclusion of emideltide on the agency's 503A Bulks List. This list determines which substances U.S. pharmacies can use to compound custom peptide treatments. The rejection came despite earlier approval for four other peptides, including BPC-157, which had previously boosted HIMS stock by over 10%. Panel members cited concerns about emideltide's safety profile and lack of compelling clinical data as reasons for the decision. The FDA typically follows its advisory panels' recommendations, suggesting that licensed pharmacies may face restrictions on using emideltide. This outcome threatens one of Hims & Hers’ fastest-growing revenue streams—personalized compounded therapies—and raises regulatory uncertainty around their expansion strategy in wellness and weight-loss treatments. The stock dropped more than 25% from recent highs. The rejection could lead to downward revisions in analyst ratings, which had previously been a
Tickers: $HIMS