Hims & Hers Health (NYSE: HIMS) shares advanced 3.4% to close at $32.74 on Thursday, outperforming the S&P 500, which declined 1.2% on the same day. The gain came after a U.S. Food and Drug Administration advisory panel endorsed the use of four unapproved peptides—BPC-157, emideltide, Semax, and Epitalon—for pharmacy compounding. However, the stock's upward momentum was tempered by the reality that the FDA's formal rulemaking process could extend for up to one year, and the panel's vote is non-binding.
Potential Revenue Opportunity
Leerink Partners projects that peptide sales could reach $440 million for Hims & Hers in 2027, representing approximately 15% of the company's 2026 midpoint revenue guidance of $2.9 billion. This estimate is based on a $2.2 billion total peptide market and a 20% market share for Hims. In a more optimistic scenario, using Needham's higher market estimate of $3.3 billion, Hims could see sales of $660 million, or 23% of its 2026 revenue midpoint. Neither scenario reflects official company guidance.
Regulatory and Market Context
The FDA panel's backing is a positive signal, but the agency is not obligated to follow the recommendation. The official rulemaking process, including public comment periods and finalization, could take up to a year, according to analysts. This timeline introduces uncertainty, especially given the limited safety data available for compounded peptides, which are not FDA-approved. Panelist Elizabeth Rebello voiced concerns, stating, "I'm concerned that we're responding to a market-induced demand rather than a decision based in solid science."
Despite the regulatory hurdles, Hims has been positioning itself in the peptide space. The company acquired a manufacturing plant with peptide capabilities in 2025, and CEO Andrew Dudum stated in May that the firm could enter the category "at scale." Chief Medical Officer Anant Vinjamoori told the panel on Thursday that the company stands to benefit commercially, though a launch date has not been determined.
Stock Performance and Analyst Outlook
Hims shares had fallen 4.5% over the prior full week, closing at $32.84 on July 17, and edged down another 0.3% by Thursday's close. On the day of the panel decision, the stock outperformed the broader market by 4.6 percentage points. Options markets are pricing in a 14% swing in either direction by month-end, according to Reuters. The company is scheduled to report its second-quarter earnings on August 10.
Leerink analyst Michael Cherny maintained a Market Perform rating with a $25 price target, which is 24% below Thursday's closing price. The cautious stance reflects the lengthy regulatory timeline and the risks associated with unapproved products.
Broader Implications
The FDA panel's decision could open a new revenue stream for Hims, which currently generates most of its sales from GLP-1 medications and existing wellness offerings. Peptides are expected to complement, not replace, these core products. However, the path to market remains uncertain, and the company's ability to capitalize on the opportunity will depend on the FDA's final rule and the evolving competitive landscape.
The FDA will continue discussions on Friday, focusing on emideltide, Semax, and Epitalon, with the meeting scheduled to conclude at 4:15 p.m. EDT. Investors will be watching closely for any updates that could clarify the timeline and potential impact on Hims' financial outlook.
