The FDA will ask an outside panel to weigh whether 7 popular peptides can be produced by compounding pharmacies, opening a potential new market for Hims & Hers
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Hims & Hers stock closed 13.7% higher earlier this week after the Food and Drug Administration scheduled a July 23-24 meeting of its Pharmacy Compounding Advisory Committee to consider whether seven peptides should be added to a list of substances that compounding pharmacies are permitted to produce.
On July 23, the committee will review BPC-157, KPV, TB-500, and MOTs-C. Emideltide, Semax, and Epitalon are slated for July 24. A second follow-up session addressing five more peptides is expected before February 2027 concludes, STAT News reported. The committee's recommendations are not binding, and the FDA does not have to follow them.
Premarket trading the next morning added another 9.6% to the company's gains, MarketWatch reported; the telehealth company had previously told investors in February that peptides were among the categories it was gearing up to enter.
"The FDA's plans to more clearly define the regulatory status of several peptides is an important step toward moving these treatments out of the gray market and into more trusted channels overseen by vetted healthcare professionals," Pat Carroll, Hims & Hers' chief medical officer, said in a statement.
In 2023, the FDA removed 19 peptides from the approved compounding list after regulators found safety concerns related to cancer and damage to the liver, kidneys, and heart, according to CBS News. The agency's outside pharmacy advisers supported this decision, saying the substances did not meet safety standards. The July meeting will consider adding back seven of these peptides.
During a February appearance on Joe Rogan's podcast, Kennedy telegraphed the regulatory shift, telling the host that he personally turns to peptides and has found them effective for treating his own injuries. Kennedy has pledged to make peptides more accessible, according to CBS News.
Critics have raised concerns about the shift. Dr. Peter Lurie, a former FDA official who leads the Center for Science in the Public Interest, told CBS News the move poses a "profound threat" to the agency's drug-vetting system. Dr. Eric Topol, who researches the issue at Scripps Research Translational Institute, warned that none of the peptides being considered have been backed by evidence demonstrating they are safe or effective.
Compounding industry representatives have argued, meanwhile, that restrictions on peptides drove demand toward an unregulated gray market of imported chemicals. Scott Brunner of the Alliance for Pharmacy Compounding cautioned that the July session is only the beginning of what he called a "protracted process," pointing out that a green light from the panel would not itself change the rules — the FDA would still need to go through the formal rulemaking process before any changes took effect, according to CBS News.
The peptide category has drawn broader commercial interest beyond Hims & Hers. Weight-loss platform Noom recently acquired a pharmacy that already produces some peptides, according to MarketWatch.
The broader peptide market has grown rapidly, driven partly by consumer familiarity with GLP-1 weight-loss drugs such as Ozempic and Wegovy — themselves peptides — which introduced millions of Americans to the category. International anti-doping bodies prohibit BPC-157 and TB-500 in competitive sports, and human clinical research on these compounds remains sparse.
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