The FDA staff’s view clashes with RFK Jr.’s push to deregulate peptides and move more of them toward Category 1 status.
- FDA staff said there was insufficient evidence to support compounding BPC-157, Emideltide, Epitalon, KPV, MOTS-c, Semax, and TB-500.
- The agency also said safety concerns could not be ruled out, citing limited human data and unclear product forms.
- Needham’s Ryan MacDonald said the FDA staff view was “a bit of a surprise,” but “not the end of the conversation,” and he still sees an approval path.
Shares of Hims & Hers Health, Inc. (HIMS) slipped 0.3% overnight heading into Wednesday after FDA scientists cast doubt on seven popular peptides, raising uncertainty around a regulatory opportunity investors had been watching closely.
HIMS stock has jumped 33% in June, with shares also tracking a weekly gain.
FDA Staff Challenges Peptides
Ahead of a July 23-24 Pharmacy Compounding Advisory Committee meeting, FDA staff said there was not enough evidence to support allowing compounding pharmacies to make BPC-157, Emideltide, Epitalon, KPV, MOTS-c, Semax and TB-500. They also said safety concerns could not be ruled out.
The peptides have gained popularity in wellness circles for weight loss, injury recovery, joint pain and other uses, but many remain outside the FDA-approved drug market and are often sold online through “research use only” channels. The staff views clash with Health Secretary Robert F. Kennedy Jr.’s broader push to deregulate peptides.
Kennedy has said that he used peptides on injuries with “really good effect,” and in April reclassified 12 peptides as Category 1 substances, an early step toward potentially allowing compounding pharmacies to produce them. Supporters say that licensed compounding could move peptides out of the gray market and into safer, regulated channels.
FDA scientists, however, pointed to limited human data, unclear product forms and unresolved safety risks. Former advisory committee member Dr. Anita Gupta said earlier reviews raised concerns about immune reactions: “At the time, the FDA presented a lot of adverse event data that showed there was a risk of immunogenicity — immune reactions — and that raised some red flags for the committee.” She also flagged contamination risks, saying some products have shown “heavy metals,” “microbial contamination” or mislabeling.
Hims has already taken steps to position itself for the opportunity. In early 2025, Hims acquired a California-based peptide manufacturing facility to boost its domestic supply chain and support future work in preventive health, metabolic optimization, cognitive performance and recovery science. Several analysts have said that the peptides opportunity could open the door to a new revenue stream worth billions of dollars.
Needham Sees Room For Peptides Approval
Needham analyst Ryan MacDonald said that the FDA staff recommendation was “a bit of a surprise,” but not a final rejection. “This is not the end of the conversation,” he told the Hims House investor community on X, adding that approval odds may be “slightly less,” but he is “still operating under the assumption that they will get approved.”
MacDonald said that the advisory committee must still review the evidence, hear stakeholder comments and make its recommendation before the FDA issues a final decision. He added that FDA leadership controls the outcome, while HHS oversees the agency and RFK Jr. has been vocal in supporting peptide deregulation.
How Do Retail Traders Feel About HIMS?
On Stocktwits, retail sentiment for HIMS was ‘bearish’ amid ‘low’ message volume.
One user said, “$HIMS tomorrow is July! I think we are going to see a bullish day tomorrow! Meetings on horizons time to get in now for the ride I expect $40 soon”
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A user posted a poll asking HIMS traders how much of the peptide opportunity is already priced into the stock. Of the 52 respondents, 54% said it was only partially priced in, 33% said it was not priced in at all and 13% said it was fully priced in.
View this Stocktwits post
HIMS stock has declined 30% over the past year.
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