Hims & Hers Health’s Peptide Opportunity Tempered By FDA Recommendation, Says Analyst

The FDA’s recommendation against adding seven peptides to the 503A Bulk List weighs on Hims & Hers Health Inc ‘s (NYSE: HIMS ) peptide optionality narrative, BofA Securities said.

Analyst Allen Lutz maintained a Neutral rating while raising the price target to $36 from $25.

The FDA released briefing materials this week ahead of Pharmacy Compounding Advisory Committee (PCAC) meetings reviewing the seven peptides, Lutz said.

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He added that: The PCAC meeting is scheduled for July 23 to 24.

These seven peptides were planned for discussions.

The FDA’s recommendation of these peptides not being included on the 503A Bulk List appears to be preliminary.

The FDA will not issue a final determination until it receives inputs from the advisory committee process.

The FDA’s key concerns include limited clinical evidence, unresolved safety/quality questions, and insufficient support for the proposed use cases.

Under the 503A framework, inclusion on the 503A Bulk List would allow state-licensed pharmacies to compound these peptides under review.

Why This Matters Lutz says peptides have a large addressable market.

The FDA’s move to remove various wellness peptides from the Category 2 restricted list and schedule reviews is a positive development for Hims & Hers.

The briefing materials suggest the PCAC "has an uphill battle" to shift the FDA’s stance on these peptides, the analyst said. "Moreover, this indicates that the legal pathway for broad peptide compounding, including other peptides to be reviewed later this year and in 2027 could be narrower or more contested than some previously believed," he further wrote.

HIMS Price Action: Shares of Hims & Hers Health had risen by 9.58% to $37.99 at the time of publication on Wednesday.

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