FDA顾问委员会支持将BPC-157纳入503A原料清单，Hims & Hers盘中大涨

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Investing.com -- Hims & Hers Health stock rallied 4.9% in afternoon trading after the FDA’s Pharmacy Compounding Advisory Committee voted 8-6, with one abstention, to recommend adding BPC-157 to the Section 503A Bulks List — a move that would open a legal prescription compounding pathway for the widely sought peptide. The outcome was a meaningful positive surprise for Hims & Hers, given that FDA staff had previously signaled skepticism about the evidence base for the compound, citing limited human data and unresolved safety concerns.
The vote carries particular strategic weight for Hims & Hers because the company has been actively positioning itself in the peptide space, having acquired a California-based peptide manufacturing facility in early 2025. While the advisory committee’s recommendation is non-binding and the FDA retains final authority over any reclassification, investors interpreted the narrow but favorable outcome as a meaningful step toward legitimizing a product category that Hims & Hers has already begun building around. Additional votes on other peptides — including KPV, TB-500, and MOTS-c — are also scheduled for today, with three more compounds up for review on Friday, keeping further potential catalysts in play.
The broader market backdrop offered no tailwind for the stock today, with the S&P 500 sliding 1.4%, the Dow Jones falling 1.1%, and the Nasdaq dropping 2.3%, underscoring how decisively the company-specific regulatory news drove HIMS’s outperformance. Sentiment heading into the meeting had been cautious, with the stock having fallen for three consecutive sessions prior, partly weighed down by the CFO’s sale of roughly $229,000 in shares just ahead of the FDA event.
Taken together, the combination of a better-than-feared regulatory outcome, the company’s pre-existing peptide infrastructure, and heavily depressed pre-event positioning created the conditions for today’s sharp rebound, with shares swinging from a session low of $30.81 to a high of $35.85 before settling into afternoon trade.
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