COMPASS Pathways (CMPS) said Wednesday its applications for regulatory approval of its psilocybin-based depression treatment remain on track, even as the company acknowledges the likelihood of clearance falling in the first half of 2025 rather than before year-end.
The company, whose shares were trading around $13.89 in pre-market activity ahead of the TD Cowen 6th Annual Novel Mechanisms in Neuropsychiatry Summit, completed a rolling new-drug application to the Food and Drug Administration targeting submission in the fourth quarter. Stock has gained 193% over the past year and carries a market capitalization of approximately $1.92 billion.
Kabir Nath, COMPASS Pathways chief executive, confirmed the filing timeline during a panel discussion moderated by TD Cowen associates Rita and Emma. "In terms of status, we are completely on track to complete the filing in Q4. I can confirm that," Nath said. He added that while an "extraordinarily unlikely scenario" could allow approval and federal rescheduling by year-end, "the likelihood is this will fall somewhere in the first half."
The FDA typically requires about 60 days to accept an NDA filing, and during the session Dr. Maurizio Fava, a division director at the FDA, discussed an aspirational target of a 30-to-60-day review period. That timeline, however, was not presented as a binding commitment.
Parallel to the FDA process, COMPASS Pathways is pursuing rescheduling of psilocybin by the Drug Enforcement Administration. The DEA normally takes roughly 90 days to act on rescheduling requests. An executive order issued in April 2024 directed agencies to work more closely and accelerate the process. If the DEA reschedules psilocybin, 44 to 45 states classified as "trigger states" would automatically follow within 30 days, meaning approximately 93% of the U.S. population would reside in jurisdictions where the substance is immediately eligible for legal medical use. Only five or six states lack trigger provisions.
The company's Phase 3 COMP005 trial tested a 25-milligram dose of COMP360 against placebo in patients with treatment-resistant depression who had failed at least two prior treatments during their current episode. Participants had an average illness duration of at least three years with multiple prior episodes. Primary efficacy was measured by change from baseline on the Montgomery-Åsberg Depression Rating Scale at week 6. Parts A and B were blinded through week 26 with a single-blinded retreatment option; Part C served as an open-label extension permitting one additional 25-milligram dose for both prior-treatment groups.
Steve Levine, the company's chief patient officer, reported that response rates to repeated dosing were comparable to the initial treatment, with greater depth and durability. "Essentially an immediate benefit for those who respond that is very durable, and with now one, two, or three treatments, durable out to 52 weeks," Levine said, describing the profile as generally safe and well-tolerated.
On the commercial side, Lori Engelbert, chief commercial officer, outlined that the launch sales force will cover more than 8,000 interventional psychiatry centers and 2,000 to 2,500 referring physicians, including psychiatrists and primary care doctors. The Interventional Psychiatry Network has been adding roughly 500 sites per quarter on average over the past 18 months, with medical science liaisons having spent nearly three years in the field building infrastructure.
Reimbursement progress includes Category III CPT codes already secured for the procedure, with an anticipated transition to Category I codes in approximately 18 months. Nath noted the base-case assumption is Schedule III placement, which carries minimal practical difference from Schedule II for on-site storage and documentation given that the drug is administered and stored at approved treatment centers rather than dispensed at retail pharmacies. The commercial model draws on precedent from Johnson & Johnson's SPRAVATO, where roughly 80% of dosing volume comes from fewer than 2,000 high-volume centers representing about 20% of sites.
