Hims & Hers Health, Inc. (HIMS) shares climbed 1% in overnight trading late Thursday after a divided FDA advisory panel recommended easing restrictions on four peptides—BPC-157, KPV, TB-500 and MOTS-C—potentially opening a new market for telehealth firms. The FDA's Pharmacy Compounding Advisory Committee narrowly voted to recommend adding the peptides to the 503A Bulks List, which would allow specialized pharmacies to compound them for individual patients. The recommendation is not FDA approval and still requires formal agency rulemaking. HIMS US Stocks jumped more than 3% to $32.74 on Thursday, but remains on track for a third consecutive weekly loss and its worst monthly run since February. FDA career scientists opposed the move over weak evidence, safety concerns and unclear product identities.
FDA Advisory Panel Votes to Recommend Four Peptides for Compounding Access
The FDA's Pharmacy Compounding Advisory Committee voted to recommend adding BPC-157, KPV, TB-500 and MOTS-C to the 503A Bulks List. BPC-157, KPV and TB-500 each received eight yes votes, six no votes and one abstention. MOTS-C received seven yes votes, five no votes and two abstentions. The vote is not an FDA approval, and the agency must still decide whether to advance the change through formal rulemaking.
Hims Chief Medical Officer Anant Vinjamoori, who addressed the committee, called the recommendation a "meaningful step" toward regulated access. "Millions of Americans are already accessing these treatments through the gray market," Vinjamoori said, arguing that a supervised pathway is the best way to protect patients from dangerous products. "Peptides are simply our newest frontier," he added.
Hims' rival telehealth firm Noom also presented to the committee. Its Chief Medical Officer Jeffrey Egler said that allowing BPC-157 compounding would not create new demand but would give an existing market "a quality floor."
Leerink Partners Estimates $2.2 Billion Telehealth Market Potential
Leerink Partners called the outcome a "positive catalyst" for Hims, noting that BPC-157 is "likely one of the more commercially viable" peptides under review. The brokerage has estimated that allowing all seven peptides being considered could create a $2.2 billion annual telehealth market, with Hims potentially capturing about 20%. Leerink, however, maintained a Market-Perform rating and $25 price target, implying a 24% downside from current levels. The firm cited uncertainty around Hims' ability to build and scale a new peptide platform.
FDA Scientists Cite Limited Evidence and Safety Risks
The panel's support came over strong objections from FDA career scientists, who cited limited clinical evidence, safety risks and uncertainty about the chemical identity of some products. "We've never faced a problem of, 'What is it?'" FDA official Russell Wesdyk told the committee.
Supporters argued that regulated compounding would be safer than leaving consumers to purchase "research use only" products online. "I'm concerned that we're responding to a market-induced demand rather than a decision based in solid science," panelist Elizabeth Rebello said. Brian Lee of USC's Keck School of Medicine said that the recommendation could be harmful and argued that decisions "should be objective and based on facts, not subjective and based on opinion."
Martin Shkreli Announces Short Position on HIMS
Former hedge-fund manager Martin Shkreli took the other side of the Hims rally. "Shorted $HIMS," Shkreli said on X. "Peptides are fake medicine. We have come far in the last 70 years of medicine, let's not go backwards please."
Shkreli, widely known as "Pharma Bro," became notorious after raising the price of the life-saving drug Daraprim from $13.50 to $750 per pill. He later served more than four years in prison for defrauding investors and has since returned as an online stock commentator known for provocative bearish calls.
Retail Sentiment Flips to Extremely Bullish
On Stocktwits, retail sentiment for HIMS flipped to "extremely bullish" from "bearish" levels a day ago amid a 408% surge in 24-hour message volumes.
One user said, "$HIMS BBC 157 and T5 100 healed my partially torn tendon in my elbow anyone who's calling peptides fake medicine you're just jealous."
Another user said, "$HIMS it means HIMS can start compounding peptides in the California peptide manufacturing plant that they bought speculatively. Which they will then sell. Back to $70 soon."
HIMS stock has declined 44% over the past year.
FAQ
What did the FDA advisory panel recommend for Hims on Thursday?
The FDA's Pharmacy Compounding Advisory Committee voted to recommend adding four peptides—BPC-157, KPV, TB-500 and MOTS-C—to the 503A Bulks List, which would allow specialized pharmacies to compound them for individual patients. The recommendation is not FDA approval and still requires formal agency rulemaking.
How much did HIMS stocks move after the FDA panel vote?
HIMS stocks jumped more than 3% to $32.74 on Thursday and climbed 1% in overnight trading late Thursday. The stock remains on track for a third consecutive weekly loss and its worst monthly run since February.
What is Leerink Partners' price target for HIMS?
Leerink Partners maintained a Market-Perform rating and $25 price target for HIMS, implying a 24% downside from current levels. The firm estimated that allowing all seven peptides being considered could create a $2.2 billion annual telehealth market, with Hims potentially capturing about 20%.
