August 2026 Newsletter: Pharma’s psychedelic bets

Dear colleagues,

July offered insight into the growing momentum of psychedelics. Late-stage programs are approaching FDA review, while large pharmaceutical companies are committing capital to the category. These developments shift attention toward a practical question: which treatments can pair durable efficacy with a delivery model that clinics can support?

Spravato laid the groundwork for scaling supervised delivery.

Johnson & Johnson’s Spravato, an esketamine nasal spray approved for adults with treatment-resistant depression, reported $584 million in second-quarter sales, up 40.8% from last year, including $514 million in the United States. It is also approved, in combination with an oral antidepressant, for major depressive disorder with acute suicidal ideation or behavior. As a Schedule III drug, it can only be administered in REMS-certified healthcare settings under provider supervision, with at least two hours of monitoring. Its growth shows that supervised treatment can reach commercial scale and may give future entrants an established infrastructure to build on.

Big Pharma is signaling a preference for shorter visits.

On July 16, Eli Lilly agreed to acquire AtaiBeckley for $2.8 billion in cash and up to $1 billion in milestone-based payments. Its lead asset, BPL-003, is an intranasal mebufotenin benzoate entering Phase 3 for treatment-resistant depression. Phase 2b data showed rapid and sustained reductions in depressive symptoms after a two-hour in-clinic visit. Lilly’s move appears to fit an emerging pattern also seen in AbbVie’s purchase of Gilgamesh’s shorter-acting bretisilocin program for up to $1.2 billion and Otsuka’s acquisition of Transcend, whose methylone program is in Phase 3 for PTSD, for up to $1.225 billion. Taken together, the deals suggest a selective appetite for assets with credible efficacy, program maturity, and operational fit within existing clinical workflows.

Compass brings late-stage efficacy data but with a longer session.

The question of operational fit becomes more immediate with Compass Pathways and its late-stage synthetic psilocybin program. Psilocybin sessions typically require six to eight hours of on-site monitoring and support, against an average in-clinic visit of two hours for Spravato and BPL-003. In early July, Compass reported 26-week results from COMP006, the second Phase 3 trial of COMP360, in treatment-resistant depression. Among patients whose depressive episodes had lasted more than three years on average, 39% in the highest dose arm (25 mg) achieved a clinically meaningful symptom reduction by Week 6 and maintained benefit, on average, through Week 26. Serious adverse events were similar across doses. With their rolling NDA underway and a Commissioner’s National Priority Voucher, COMP360 could become the first classic psychedelic to reach the market. If approved, its early uptake would indicate how clinicians, patients, and payers weigh the potential for durable benefit against the demands of a six- to eight-hour treatment session.

FDA has clarified the review path and the evidence bar.

As psychedelic programs move closer to regulatory review, FDA is clarifying what it expects from the clinical trials. A central challenge in psychedelic trials has been functional unblinding, which can create expectancy bias and inflate apparent effect. FDA’s July final guidance points sponsors toward lower-dose or psychoactive controls instead of inert placebo and recommends blinded central raters and formal measurement of patient expectancy. For sponsors moving into pivotal studies, these factors warrant early discussion with the agency.

What do you think will matter most in determining which psychedelic therapies succeed in practice?

This month's newsletter was researched and drafted by Headland Associate Kaitlyn Ryu.

Let's talk.

If you are facing high-stakes, cross-functional decisions, Headland continues to be a trusted partner. Feel free to reach out to us at solutions@headlandstrategy.com to discuss how we can support your commercial, corporate development, and medical affairs strategy. 

What we are reading and listening to.

A short list of external resources we are finding helpful:

• Lilly to buy AtaiBeckley for $2.8B, further validating psychedelics (BioPharma Dive, July 16): BioPharma Dive covers Lilly’s $2.8B acquisition of AtaiBeckley, highlighting the deal rationale and analyst views on its strategic value.

• AZ-BMS rumors, Replimune, psychedelics (BioCentury This Week, August 5): BioCentury analysts discuss AstraZeneca-BMS deal rumors, Replimune, and the role of psychedelics in the current dealmaking landscape.