Biotechnology company Compass Pathways plc (Nasdaq: CMPS) announced on Wednesday that the U.S. Food and Drug Administration has accepted its Investigational New Drug application for COMP360 in post-traumatic stress disorder, enabling initiation of a late-stage Phase 2b/3 clinical trial.

Acceptance clears the start of the multicentre, randomised, double-blind COMP202 study evaluating the efficacy, safety and tolerability of COMP360 in patients with PTSD, with an open-label extension to assess longer-term outcomes. Prior Phase 2 open-label data showed COMP360 was generally safe and well tolerated, with rapid and durable symptom improvement, with results published in the September 2025 issue of the Journal of Psychopharmacology.

Compass Pathways said commercial preparations for COMP360 in treatment-resistant depression remain on track, supported by strategic clinic collaborations, including the addition of Radial as its seventh partner. A positive FDA Type B meeting in September 2025 confirmed the company's NDA submission strategy, including potential rolling submission, with further Phase 3 data disclosures planned in the second half of the first quarter of 2026 and additional results expected in early third quarter of 2026.

Balance sheet flexibility was strengthened through an amendment to the company's term loan with Hercules Capital Inc (NYSE: HTGC), increasing total availability to up to USD150m, extending the interest-only period to at least 5 January 2029 and pushing maturity to 5 January 2031. Compass Pathways said the facility supports cash runway into 2027.