HIMS
The FDA just threw a little cold water on the party
BofA Securities says the FDA’s preliminary recommendation against adding seven peptides to the 503A Bulk List takes some sparkle out of Hims & Hers Health’s peptide optionality story. That matters because the whole setup was supposed to make compounding a little easier for state-licensed pharmacies, which is basically the plumbing behind part of the opportunity.
Why investors were paying attention
Analyst Allen Lutz kept a Neutral rating on the stock, but raised his price target to $36 from $25. So this isn’t a full-on buzzkill — more like the kind of meeting where someone says, “Great idea, but let’s not get ahead of ourselves.”
The FDA’s concerns are pretty classic regulator-language bingo:
- limited clinical evidence
- unresolved safety and quality questions
- not enough support for the proposed use cases
And the agency isn’t done yet. The PCAC meeting is set for July 23 to July 24, so this is still a work-in-progress, not a final verdict.
The bigger picture
Lutz still thinks peptides are a big market, and the FDA’s move to pull some wellness peptides off the restricted list is a step in the right direction. But the briefing materials hint that the path to broad peptide compounding may be narrower — and a little more annoying — than bulls were hoping.
Big picture: Hims is still in the game, but the FDA just reminded everyone that regulatory “optional” is not the same thing as regulatory “easy.”