COMPASS Pathways PLC (NASDAQ: CMPS) (FRA: 5Y6) secured a major regulatory boost as the FDA granted a rolling review for its New Drug Application and awarded the company a Commissioner’s National Priority Voucher for COMP360.
This development, announced on Apr. 24, accelerates the path toward potential approval of the therapy for adults with treatment-resistant depression. The condition impacts millions who do not respond adequately to existing antidepressants.
COMP360 therapy consists of a single dose of synthetic psilocybin, a classic psychedelic compound, paired with psychological support from trained therapists. Developers designed it to deliver rapid relief from depressive symptoms.
The company has advanced its program with this drug significantly. In February, it reported positive results from two large Phase 3 trials involving more than 1,000 participants. These studies demonstrated statistically significant reductions in depressive symptoms, with effects that can begin within a day and persist for at least six months in many patients. Earlier Phase 2b data, published in The New England Journal of Medicine, reinforced the potential for durable responses after a single 25 milligram dose.
The rolling review allows Compass to submit completed sections of its application as they become ready, while the priority voucher delivers enhanced FDA communication and shortens the final review period to roughly one to two months once the full submission lands. These tools maintain the agency’s strict safety and efficacy standards but compress timelines for this particular candidate.
Wall Street responded swiftly to the news. Several firms — such as TD Cowen, B. Riley and Oppenheimer — raised or reaffirmed bullish price targets on Compass Pathways shares. Analysts cited the expedited timeline, which could enable a potential launch as early as late 2026 or 2027.
This momentum builds directly on President Donald Trump’s executive order titled Accelerating Medical Treatments for Serious Mental Illness. The order directs the FDA to fast-track promising therapies for mental health crises, such as psilocybin and ibogaine, and pushes the DEA to review rescheduling of psychedelics more rapidly.
The FDA also awarded similar Commissioner’s National Priority Vouchers to Wisconsin’s Usona Institute for its psilocybin candidate in major depressive disorder and to Transcend Therapeutics for its methylone (TSND-201) program targeting PTSD.
“This recognition further underscores the urgent and significant unmet need in PTSD and the potential for TSND-201 to become a rapid-acting and durable treatment option,” said Transcend Therapeutics chief executive Blake Mandell on Monday.
Read more: Optimi Health launches ibogaine initiative in response to Trump’s executive order
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