Compass Pathways shared pipeline updates alongside its FY2025 results, advancing COMP360 toward an FDA filing for treatment-resistant depression while initiating a Phase 2b/3 trial in PTSD.
Written By: Vennela Reddy, BPharm
Reviewed By: Pharmacally Editorial Team
Compass Pathways plc released pipeline updates alongside its Fourth Quarter and Full-Year 2025 Financial Results, highlighting progress for COMP360, its investigational psilocybin therapy, in treatment-resistant depression (TRD) and post-traumatic stress disorder (PTSD).
The company plans a meeting with the U.S. Food and Drug Administration to confirm its New Drug Application (NDA) strategy, including a potential rolling submission. Compass expects 26-week data from Part B of the Phase 3 COMP006 trial (NCT05711940) due in early Q3 2026, to complete the dataset required for filing. In parallel, the company is accelerating commercial preparations to be launch-ready by the end of 2026, pending approval.
Across three late-stage trials involving more than 1,000 participants, COMP360 met primary endpoints and demonstrated rapid antidepressant effects, with symptom improvements observed as early as the day after dosing. In the pivotal Phase 3 COMP005 study (NCT05624268), the 25 mg dose produced ≥25% reductions in MADRS scores at Week 6, with benefits sustained for at least six months after one or two administrations. Safety data showed most treatment-emergent adverse events were mild to moderate and resolved within 24 hours.
TRD affects approximately 4 million adults in the United States, yet fewer than 200,000 patients receive FDA-approved therapies specifically indicated for the condition. Compass believes COMP360’s rapid onset, durable effects, and infrequent dosing schedule could represent a paradigm shift and could be delivered through more than 7,300 existing U.S. treatment centers offering multi-hour treatment sessions.
In PTSD, the FDA cleared an Investigational New Drug (IND) application enabling a Phase 2b/3 trial. This follows a Phase 2 open-label study (NCT05312151) (n=22) that showed COMP360 was generally safe and well tolerated, with symptom improvements lasting up to 12 weeks after a single administration and no serious adverse events reported. The results were published in the September 2025 issue of the Journal of Psychopharmacology.
PTSD affects roughly 13 million Americans each year, yet only two medications are currently approved for the condition. With pivotal TRD data approaching and PTSD development advancing, Compass is positioning COMP360 as a potential new therapeutic option for serious mental health disorders.
Reference
Compass Pathways Announces Fourth Quarter and Full-Year 2025 Financial Results and Business Highlights, 24 March 2026, Compass Pathways – Compass Pathways Announces Fourth Quarter and Full-Year 2025 Financial Results and Business Highlights
About the Writer
Vennela Reddy, B.Pharm is a pharmacy graduate with a keen interest in clinical research, pharmacovigilance, and medical writing, with a growing focus on publishable and scientific content development. Along with this she also interested in wellness and healthcare writing due to her natural interest in those topics. In her words, she is passionate about translating complex medical data into clear, evidence-based communication.