FDA publishes its 23-24 Jul peptide advisory committee roster, tilted heavily towards peptide supporters (new, first-hand)
On Monday 29 Jun the FDA formally published the list of participants for its 23-24 Jul peptide advisory committee. This is the key advance information on the real binary event flagged repeatedly over the past few weeks, and the list shifts the odds. The core change is the people.
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The committees that reviewed compounded drugs in the past were made up mainly of academic researchers from Duke, Harvard, Johns Hopkins and the like, and they repeatedly voted down peptide ingredients as too risky for patients. On the FDA's new list, more than half a dozen members are practitioners who directly run peptide clinics, online peptide businesses or compounding pharmacies that specialise in peptides: people who make money selling peptides. Examples include Haleem Mohammed (the Gameday Men's Health chain in Florida), Gabriel Alizaidy (charges $500 for peptide and hormone consultations and promotes BPC-157 and GHK-Cu on social media) and Bobby Harshbarger (a Tennessee senator whose family compounding pharmacy sells weight-loss and longevity compounds). For HIMS, the direction is positive (near term). The re-rating narrative for the HIMS platform (a new chief medical officer who is a peptide specialist, plus Canaccord's $20 billion TAM) rests on the assumption that the FDA clears 503A peptides. With the committee switched from academic naysayers to industry supporters, the odds of a favourable outcome on 23-24 Jul have risen materially. The 7 peptides under review, including BPC-157 and TB-500, are exactly what HIMS's California peptide plant is aimed at. But there is a hidden tail risk. The committee's conflicts of interest are in plain sight, so even an approval could have its credibility and legitimacy challenged: pressure from Democratic lawmakers, the medical community and politicians in the mould of Jim Banks on 7 Jun could all intensify. On top of that, Nature pointed out on 12 Jun that these influencer peptides lack evidence of efficacy in humans. Lax regulation, a scientific vacuum and a conflicted committee make a combination that rallies first and faces a reckoning later. In short, this is not a fundamental turning point. It tips the scales of the 23-24 Jul binary event towards HIMS ahead of time, and the bet is on regulatory arbitrage, not on proven efficacy. The share price (closed at $33.39 on 29 Jun, up about 36% in June) is already well above the sell-side consensus of around $29, so the market has priced in most of an approval before the outcome is known. If the good news lands, upside is limited. If the meeting goes wrong or the outcome is challenged, the drawdown could be considerable.
Key evidence
- On Monday 29 Jun the FDA formally published the list of participants for its 23-24 Jul peptide advisory committee
- Past advisory committees were made up of academic researchers from Duke, Harvard, Johns Hopkins and others, and repeatedly voted down peptide ingredients as too risky for patients
- More than half a dozen members on the new list directly run peptide clinics, online peptide businesses or compounding pharmacies that specialise in peptides
- Haleem Mohammed: the Gameday Men's Health chain in Florida, selling peptides, testosterone and weight-loss injections
- Gabriel Alizaidy: charges $500 for peptide and hormone consultations, promotes BPC-157 and GHK-Cu on social media
- Bobby Harshbarger: Tennessee senator whose family compounding pharmacy sells weight-loss and longevity compounds
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- The 7 peptides under review include BPC-157 and TB-500, exactly the focus of HIMS's California peptide plant
- The HIMS platform re-rating narrative assumes the FDA clears 503A peptides (the new chief medical officer is a peptide specialist; Canaccord's $20 billion TAM)
- HIMS closed at $33.39 on 29 Jun, up about 36% in June and well above the sell-side consensus of around $29
- Nature pointed out on 12 Jun that these influencer peptides lack evidence of efficacy in humans
- SEC EDGAR check: the latest filing is still Carroll's Form 4 of 23 Jun; no new company announcements
Catalysts to watch
- 23-24 Jul FDA peptide advisory committee meeting: the real binary event
- The new committee leans towards industry supporters, materially raising the odds of a favourable outcome on 23-24 Jul
- Review of 7 peptide ingredients including BPC-157 and TB-500, which map directly onto HIMS's California peptide plant
- Possible clearance of 503A peptides, the core assumption of the HIMS platform re-rating narrative
- A window for the re-rating behind Canaccord's $20 billion TAM
Risks
- The committee's conflicts of interest are blatant, so even an approval could have its credibility and legitimacy challenged by Democratic lawmakers and the medical community
- Political pressure like Jim Banks's on 7 Jun could intensify, with the risk of a reckoning after approval
- Nature pointed out on 12 Jun that influencer peptides lack evidence of efficacy in humans. Lax regulation, a scientific vacuum and a conflicted committee make a combination that rallies first and faces a reckoning later
- At $33.39 the shares are well above the sell-side consensus of around $29. The market has priced in most of an approval, so upside is limited if the good news lands
- If the 23-24 Jul meeting goes wrong or the outcome is challenged, the drawdown could be considerable
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- The bet is on regulatory arbitrage, not proven efficacy. The fundamentals have not turned
- The roughly 36% gain in June has already priced in most of the expected good news
Sources 4
- MedPage Today
- PBS News
- AJMC
- SEC EDGAR
A brief is a lead for our research, not a verified conclusion or advice.