An FDA advisory panel backed six of seven peptides for possible inclusion on the 503A compounding list, with Emideltide the only rejection.
- Retail dip-buying remains strong in HIMS, with 59% of 1,100 Stocktwits poll voters saying they were buying the decline.
- The panel votes are recommendations, not FDA approvals, and the agency still has to decide whether to advance the changes through rulemaking.
- Leerink called the outcome a “positive catalyst” and estimates a potential $2.2 billion annual telehealth market, with Hims possibly capturing about 20%.
Shares of Hims & Hers Health, Inc. (HIMS) rose 1% overnight late Sunday as retail dip-buying interest picked up after Friday’s selloff and a mixed Food and Drug Administration (FDA) panel decision on seven popular peptides.
HIMS stock plunged 14% on Friday, marking its worst session in nearly six months. Shares are now down 19% in July and on track for their steepest monthly decline since February.
HIMS Retail Traders Buy The Dip
In a Stocktwits poll conducted after the decline, 59% of 1,100 voters said they were buying the dip, while 16% said they were staying away. Another 12% said they were holding their positions and 13% were watching from the sidelines.
The FDA’s Pharmacy Compounding Advisory Committee recommended adding six of seven peptides considered during its two-day meeting to the 503A Bulk Drug Substances List last week, which could eventually allow specialized pharmacies to compound them for individual patients. On Thursday, the panel backed BPC-157, TB-500, KPV and MOTS-C. On Friday, advisers also supported Epitalon and Semax.
Emideltide was the lone rejection. Panelists voted 7-6, with one abstention, against recommending both its free-base and acetate forms. The votes are recommendations, not FDA approvals. The agency is not bound by the committee’s decisions and would still need to determine whether to advance any changes through formal rulemaking.
Hims Eyes Potential $2.2B Market
Leerink Partners called the panel outcome a “positive catalyst” for Hims, noting that BPC-157 is “likely one of the more commercially viable” peptides under review. The firm previously estimated that allowing all seven peptides could create a $2.2 billion annual telehealth opportunity, with Hims potentially capturing around 20%. Leerink nevertheless maintained a ‘Market Perform’ rating and $25 price target, citing uncertainty over Hims’ ability to build and scale a new peptide offering.
Hims Chief Medical Officer Anant Vinjamoori, who addressed the advisory committee, called the recommendations a “meaningful step” toward regulated access. “Millions of Americans are already accessing these treatments through the gray market,” Vinjamoori said, arguing that a supervised pathway could offer safer access. “Peptides are simply our newest frontier.”
FDA Scientists Raise Peptides Concerns
The votes came despite objections from FDA career scientists, who cited limited clinical evidence, potential safety risks and uncertainty over the chemical identity of some peptide products. “We’ve never faced a problem of, ‘What is it?’” FDA official Russell Wesdyk told the committee. BPC-157, KPV and TB-500 each received eight yes votes, six no votes and one abstention, while MOTS-C passed with seven yes votes, five no votes and two abstentions.
Panelist Elizabeth Rebello said she was concerned the committee could be responding to consumer demand rather than “solid science,” while other supporters said that regulated compounding would be safer than leaving consumers to buy unapproved products through gray-market channels. The panel itself has also drawn scrutiny over potential conflicts of interest involving members with ties to clinics and businesses that supply peptides. The FDA added eight temporary voting members ahead of the meeting.
How Do Retail Traders Feel About HIMS?
On Stocktwits, retail sentiment for HIMS flipped to ‘extremely bullish’ from ‘bearish’ levels a week ago amid a 36% rise in 24-hour message volumes.
One user called HIMS “one of the best up and coming healthcare investments you can make.”
View this Stocktwits post
Another user said, “$HIMS When, not if peptides are available to everyone, it WILL disrupt big pharma. This so much bigger than most can even image.”
View this Stocktwits post
HIMS stock has declined 51% over the past year.
For updates and corrections, email newsroom[at]stocktwits[dot]com.<