Hims & Hers Sees New Opportunity in Peptides Amid Regulatory Shift

Shares of Hims & Hers Health jumped after Health and Human Services Secretary Robert F. Kennedy Jr. announced that the FDA plans to review peptides for potential inclusion on the 503A bulk list. This designation would allow drugs to be compounded on an individual prescribed basis rather than mass producing.

The telehealth company has been expanding its compounded GLP-1 business and is now exploring peptides as a new opportunity. Peptides are short chains of amino acids that are being explored for various health and wellness uses, but their production remains largely unregulated and scientific evidence on their long-term safety and effectiveness is limited.

Expanding into Peptides

In February 2025, Hims & Hers acquired a California-based peptide facility, marking a significant move into the space. CEO Andrew Dudum described peptide demand as "future-facing innovation" and stated that "many use cases have yet to be launched." Dr. Patrick Carroll, Hims Chief Medical Officer, welcomed the FDA's announcement, saying it would bring peptide therapy into regulated, physician-led care.

"Our medical team believes certain peptide therapies hold meaningful potential in helping Americans live healthier lives, and we are actively exploring how to expand access in a way that will be aligned with FDA guidance," Carroll said. Leerink Partners views the FDA's decision to review peptides as a positive outcome that could give Hims a clearer regulatory path to scale peptide therapies.

However, the firm notes that it will take time for peptides to boost the company's bottom line. "This would not immediately translate into revenue, but would seemingly be a growth avenue that HIMS would push hard on," said Leerink analyst Michael Cherny.

Regulatory Challenges

The FDA process is just beginning, and the July meeting will be advisory only, so change is not expected to be immediate. Of the dozen peptides listed for consideration, one, MK-677, is often treated as an illegal drug when sold for human consumption and has been banned by the World Anti-Doping Agency. Other peptides on the list, such as GHK-Cu and Semax, are generally viewed as less controversial but still lack robust scientific backing.

Secretary Kennedy has supported many medical treatments and food options outside of those backed by mainstream science. During a House Ways and Means Committee hearing, he argued that the Biden administration restricted the use of peptides due to safety concerns that he considers unfounded. "Peptides were not supposed to be regulated," Kennedy said.