389: Hims' Super Bowl fallout, and the FDA reverses course
Episode
34 min
Read time
2 min
Topics
Health & Wellness, Investing, Fundraising & VC
AI-Generated Summary
Key Takeaways
- ✓FDA Political Vulnerability: The FDA's reversal on Moderna's flu vaccine—accepting the application within days of initial rejection—followed reports that President Trump directly expressed frustration to Moderna's leadership. Investors and analysts should treat FDA decisions under the current administration as potentially subject to political override, particularly on vaccine-related matters approaching the 2026 midterm elections.
- ✓Compass Pathways Depression Trial Benchmarks: Compass defined "clinically meaningful response" as a 25% reduction on the MADRS scale—lower than the 50% threshold used in comparable trials. Remission rates at six weeks reached only 6%, using a MADRS cutoff of under 12 rather than the standard under 10. Analysts evaluating psychedelic drug approvals should scrutinize endpoint definitions carefully before drawing efficacy conclusions.
- ✓Compounded GLP-1 Regulatory Risk: Hims & Hers used liposomal technology for its compounded oral semaglutide pill—a formulation the FDA previously proposed banning from compounding, though never finalized. Companies marketing compounded GLP-1 products should treat that unfinalized proposal as a live regulatory threat, particularly as FDA enforcement escalates beyond marketing violations toward the underlying compounding framework.
- ✓Telehealth Vertical Integration Model: Direct-to-consumer telehealth companies like Hims & Hers generate revenue by vertically integrating a management services organization, affiliated medical groups, and in-house pharmacies—capturing drug revenue, not just consultation fees. White-label infrastructure now allows new telehealth brands to launch in days by renting this structure, operating in regulatory gaps written before internet-era healthcare delivery existed.
- ✓Psychedelic Medicine Commercial Pathway: Compass Pathways' psilocybin drug requires patients to remain in treatment facilities for six to eight hours per session, creating significant insurance coverage and cost challenges. However, its less frequent dosing schedule compared to J&J's ketamine-derived Spravato—which already generates substantial revenue—positions it as a commercially viable option if FDA approves it, despite the high per-session healthcare system cost.
What It Covers
Three major healthcare stories dominate: the FDA's reversal on Moderna's flu vaccine application amid political pressure from the Trump administration, Compass Pathways reporting positive Phase 3 psychedelic depression trial results, and Hims & Hers facing FDA scrutiny, an HHS-DOJ referral, and a 30% stock drop after launching a compounded semaglutide pill.
Key Questions Answered
- •FDA Political Vulnerability: The FDA's reversal on Moderna's flu vaccine—accepting the application within days of initial rejection—followed reports that President Trump directly expressed frustration to Moderna's leadership. Investors and analysts should treat FDA decisions under the current administration as potentially subject to political override, particularly on vaccine-related matters approaching the 2026 midterm elections.
- •Compass Pathways Depression Trial Benchmarks: Compass defined "clinically meaningful response" as a 25% reduction on the MADRS scale—lower than the 50% threshold used in comparable trials. Remission rates at six weeks reached only 6%, using a MADRS cutoff of under 12 rather than the standard under 10. Analysts evaluating psychedelic drug approvals should scrutinize endpoint definitions carefully before drawing efficacy conclusions.
- •Compounded GLP-1 Regulatory Risk: Hims & Hers used liposomal technology for its compounded oral semaglutide pill—a formulation the FDA previously proposed banning from compounding, though never finalized. Companies marketing compounded GLP-1 products should treat that unfinalized proposal as a live regulatory threat, particularly as FDA enforcement escalates beyond marketing violations toward the underlying compounding framework.
- •Telehealth Vertical Integration Model: Direct-to-consumer telehealth companies like Hims & Hers generate revenue by vertically integrating a management services organization, affiliated medical groups, and in-house pharmacies—capturing drug revenue, not just consultation fees. White-label infrastructure now allows new telehealth brands to launch in days by renting this structure, operating in regulatory gaps written before internet-era healthcare delivery existed.
- •Psychedelic Medicine Commercial Pathway: Compass Pathways' psilocybin drug requires patients to remain in treatment facilities for six to eight hours per session, creating significant insurance coverage and cost challenges. However, its less frequent dosing schedule compared to J&J's ketamine-derived Spravato—which already generates substantial revenue—positions it as a commercially viable option if FDA approves it, despite the high per-session healthcare system cost.
Notable Moment
Hims & Hers launched its compounded semaglutide pill the same week the Trump administration debuted its own discounted Wegovy pill at $1.49 cash-pay versus Hims' $49 price—a timing collision that analysts suggest accelerated the aggressive regulatory response from both FDA and HHS.
Episode Transcript
Welcome to this week's episode of the Read Out Loud, a weekly biotech podcast from STAT. I'm Allison DeAngelis. I'm Adam Forstein. And I'm Elaine Chen. It's Thursday, February 19. And on this week's episode, our colleague Katie Palmer joins us to discuss the telehealth compounder Hims and Hers, its decision to sell a version of Novo Nordisk new weight loss pill, and the lawsuits and controversy that ensued. But first, a recap of this week's news and a word from our sponsor. Science doesn't stop at your job description, and neither should your curiosity. New Scientist brings you stories that reach beyond the day to day and into the discoveries shaping our future. Whether you're at work or simply in need of inspiration, there's always more to explore and more to enjoy. With trusted journalism since 1956, New Scientist gives you a place to escape, think bigger, and follow your curiosity wherever it leads. Start exploring with an exclusive three month free trial to New Scientist. Visit newscientist.com/stat. Okay. Let's just get right into it as I often say for the newsletter because we have a lot of news to get to. So as you recall, Moderna last week gave a surprising announcement that the FDA said it would not accept the company's application for its flu shot. The decision centered around disagreements on the compared group that Moderna used in its clinical trial. And, we've reported that this decision was made by top agency official, Vinay Prasad, who overruled, scientists in the vaccine center. But yesterday on Wednesday, it seems agency officials have reversed course. The agency will now review the product in adults fifty to sixty four through a regular pathway. And for adults 65, they'll review through an accelerated approval pathway with requirement to run a post marketing study. And the FDA now anticipates making a decision by August 5. I feel like this, reversal and and actually, just calling it a reversal is sort of a charged way of describing it. Right? Because I think that's how a lot of people have described what's happened this week, that the FDA reversed course. At first, they had refused to review Moderna's application, and now they are going to. There are others out there, and, I have seen a lot of fighting on, x slash Twitter over this, and a lot of some of this fighting has been directed at me. And there are a group of people who believe that the FDA, in fact, didn't reverse course, that this is more about Moderna giving in to the FDA and that if you know, essentially, the argument there is that if the FDA had not issued this refuse to file letter, had had refused to, review the application, then, Moderna would not have conceded that they might need more data on, the flu vaccine for this older, you know, the the 65 and older population. And I really it's a it's a little bit of a Rorschach …
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