NEW YORK, April 16, 2026, 14:35 EDT
Shares of Hims & Hers Health surged Thursday after the FDA signaled it would review restrictions on certain peptides—a move that’s opened up a new narrative for investors as the telehealth firm shifts focus from promoting compounded GLP-1 drugs. By early afternoon in New York, the stock was changing hands at $26.65, up $2.36 on the day.
Timing is crucial for Hims, which overhauled its U.S. weight-loss plan just last month. In March, the company cut out advertising for compounded GLP-1 offerings across its platform and all marketing channels, while at the same time moving to widen access to branded therapies via a deal with Novo Nordisk.
Newly released FDA documents reveal the agency revised its 503A ingredient categories on April 15, with plans to drop 12 peptides from Category 2—the group reserved for ingredients flagged over major safety issues—after those nominations were pulled. The FDA also scheduled a Pharmacy Compounding Advisory Committee meeting for July 23-24 to review seven peptides for potential addition to the 503A bulks list, which determines which bulk substances are eligible for use in certain compounded drugs.
The lineup starts with BPC-157, KPV, TB-500 and MOTs-C on day one, followed by emideltide, semax, and epitalon on day two. According to the FDA, these will be up for review as potential treatments for a slate of conditions: ulcerative colitis, wound healing, obesity, migraine, chronic insomnia, and opioid withdrawal.
Peptides—essentially short strings of amino acids—are getting more attention these days, thanks in part to top-selling drugs like Novo Nordisk’s semaglutide and Eli Lilly’s tirzepatide. Compounding, which involves pharmacies preparing custom versions of medicines using active ingredients, has come up too.
Dr. Pat Carroll, Chief Medical Officer at Hims, described the FDA shift as “an important step” that could bring peptide therapies out of the gray market and under proper medical oversight. The company, he said, is “actively exploring” ways to broaden access while keeping within FDA guidelines and its own safety protocols. Hims Newsroom
Analysts wasted no time spinning the development as a win for Hims. Michael Cherny at Leerink Partners described the move as a “clear positive,” arguing peptides could “fill the growth hole” as the firm shifts away from personalized GLP-1 compounding. Reuters flagged BofA’s Allen Lutz, who pointed to room for new revenue streams and opportunities to redeploy GLP-1 capacity. TipRanks
Hims has been laying groundwork for just this scenario. Last year, the company picked up a peptide facility in California, aiming to tighten up its U.S. supply chain and lay the foundation for upcoming peptide-focused therapies. After closing at $21.36 on Tuesday, the stock shot up, finishing Wednesday at $24.29, according to company stock data.
The path forward is anything but clear, and any benefits won’t materialize right away. Dr. Peter Lurie, a former FDA official, called the process a “profound threat” to the agency’s drug-vetting system. Scott Brunner, who heads the Alliance for Pharmacy Compounding, argued the transition has to move cautiously, calling it “at its core, a supply chain issue.” Even if FDA advisers sign off on expanded access this July, the agency still faces a full rulemaking slog. the-journal.com
The FDA set a July 22 deadline for public input on the July meeting. While the panel’s recommendation isn’t a final decision, it’s the next key hurdle as regulators weigh if peptides could shift out of regulatory limbo and into wider pharmacy compounding.
