Hims & Hers shares jump 6% as U.S. draft allows compounding of six peptides under conditions

Key Facts

Hims & Hers shares rose 6% on October 28 as the U.S. Department of Health and Human Services published a draft interim policy on compounding unapproved peptides, according to TIKR coverage. The draft covers six peptides: BPC-157, Epitalon, KPV, MOTS-c, Semax and TB-500, according to The Washington Post. The policy allows the department to exercise enforcement discretion toward specified compounding facilities that meet its conditions. The shares’ rise coinciding with the announcement does not establish that the policy alone caused the gains. The move also opens a temporary regulatory window in a market the company is watching, but does not grant the peptides drug approval.

The draft requires prescriptions for individual patients, traceable ingredients, quality testing and reporting of safety risks, according to The Washington Post. Reuters reported that the requirements also include manufacturing and labeling standards, and apply to certain compounding facilities, not all pharmacies. The Department of Health and Human Services said it may reconsider the interim policy if signs of safety risks or product quality problems emerge. The policy does not constitute approval by the U.S. Food and Drug Administration of the peptides’ safety or effectiveness. The department said one of its goals is to curb the use of research-grade peptides supplied by foreign manufacturers.

The draft follows regulatory debate over whether these substances should be included among those that pharmacies may compound. At a meeting in July, an FDA advisory committee recommended considering whether six of seven peptides should be made available for compounding, according to The Associated Press. Committee members voted in several ballots by 8 to 6, with one abstention, in favor of placing the peptides on a list of substances considered safe to compound, but the committee’s recommendations are not binding on the agency. FDA scientists, by contrast, said evidence available on the peptides’ effectiveness for proposed uses is limited. The agency’s review included five studies of BPC-157 that its staff described as short, small-sample and exploratory in dosage.

Safety concerns remain part of the regulatory context. The FDA warns that compounded drugs containing BPC-157 may carry immune risks with some routes of administration and could involve complications related to peptide-specific impurities. At the same time, the Department of Health and Human Services said its draft could be revised if safety signals or quality problems emerge. Analysts estimated, according to Reuters, that the peptide industry could quickly become a market worth between $2 billion and $3 billion if it gains legal status. The estimate reflects the scale of potential commercial interest, but does not define Hims & Hers’ share of the market or when it might realize it.

For Hims & Hers, the draft does not mean peptide products are about to launch or that the company’s margins will improve. Chief Executive Andrew Dudum said the company is waiting for the FDA to complete final rules before selling peptides under review. Reuters reported that the company has begun stability and validation testing on BPC-157 as part of its preparations for a launch. Investors and analysts told Reuters in August that sales of some legally available peptides, which the company planned to launch in 2026, would not drive revenue growth during the year. Experts also estimated that completing the final rules could take about a year, leaving launch timing dependent on the regulatory process.

Attention is turning to the company’s third-quarter results, due after the market closes on November 9, 2026, according to a Nasdaq notice about the company’s announcement. The date comes as investors await clarity on the timing of peptide product launches and the path to final rules. But the company said it is waiting for those rules to be completed before launching substances still under review. The shares’ 6% rise on the day the draft was published coincided with the regulatory development, according to TIKR coverage, without establishing that the announcement was the sole factor behind the move. The upcoming results will provide a set date to follow what the company may announce about its plans, while the draft itself is not authorization to sell.