HIMS & Hers Health FDA review of peptide therapies

On July 24, Hims & Hers Health (HIMS) stock plummeted after an FDA advisory panel declined to recommend adding emideltide to the 503A Bulks List, which governs substances for compounded peptide treatments. The panel had previously narrowly supported four other peptides. This decision was a setback for HIMS, which had been exploring peptide therapies as a new revenue stream.

The market impact was immediate and significant. HIMS stock tanked, with shares closing down 28% on the day. The FDA's decision raised questions about the regulatory path for peptide therapies, affecting other companies in the telehealth and biotechnology sectors with similar interests. Bank of America, however, raised its price target on HIMS to $25, citing potential new revenue streams from wellness peptides and repurposing existing manufacturing capacity.

Next, investors should watch for the FDA's final decision on emideltide, expected in late 2023. Additionally, HIMS's Q2 earnings, due in early August, will provide insight into the company's response to this setback and its overall financial health. Lastly, the FDA's ongoing review of compounded peptide therapies, which could expand legal access to these treatments, may have broader implications for HIMS and the industry.