Hims & Hers shares jump as FDA begins review of restricted peptide compounds Proactive uses images sourced from Shutterstock
Shares of Hims & Hers Health (NYSE:HIMS) rose more than 8% to about $26 after the US Food and Drug Administration (FDA) moved to begin a formal review process that could eventually reshape the regulatory status of several wellness peptides used in compounding pharmacies.
The FDA announced it will hold meetings on July 23 and 24 with its Pharmacy Compounding Advisory Committee to discuss whether multiple peptide-related bulk drug substances should be considered for possible inclusion on the 503A bulks list.
The substances under review include BPC-157 KPV, TB-500, MOTs-C, emideltide, semax, and epitalon. The agency also opened a public comment docket ahead of the meetings, with submissions due in early July.
Following the announcement, Bank of America raised its price objective for Hims & Hers Health to $25 from $21, while maintaining a ‘Neutral’ rating, pointing to higher peer valuation multiples and increased long-term optionality tied to emerging peptide-related developments.
The firm also lifted its target multiple from roughly 21.5x to about 25.5x, reflecting both broader sector re-rating and potential strategic upside.
The analysts see the move as incrementally constructive for long-term optionality but not a near-term earnings driver. The review process could, in theory, expand potential compounding pathways and create new categories of addressable demand, though the ultimate outcome remains uncertain.
In particular, it remains unclear whether key wellness peptides will ultimately be permitted for compounding or broader commercialization, with the view that “It is still unclear whether key wellness peptides will be allowed for compounding or mass marketing.”
The same analysis frames the development as an early-stage procedural step rather than a regulatory unlock.
“This is an initial step in the evaluation process and not a commercial unlock of the opportunity,” the analysts wrote, underscoring that any meaningful impact would depend on future FDA decisions following the committee review process.
While the announcement does not change current restrictions, it is seen as adding strategic optionality for companies with exposure to compounding infrastructure.
For Hims & Hers, this includes the possibility, if future rulings are favorable, of repurposing portions of its existing capacity tied to GLP-1-related operations toward other peptide-based offerings, potentially helping offset fixed costs already embedded in operating assumptions.
