Businesswire·2026-01-07 11:30Core Insights - Compass Pathways plc has received FDA acceptance for its IND application for COMP360, allowing the start of a late-stage clinical trial for PTSD [1][5] - The company aims to address the significant unmet need in PTSD and treatment-resistant depression (TRD) through innovative therapies [2][14] Late-Stage Clinical Trial for PTSD - The Phase 2b/3 clinical trial (COMP202) will evaluate the efficacy, safety, and tolerability of COMP360 in PTSD patients [5] - The trial consists of two parts: a 12-week blinded study comparing two doses of COMP360 (25 mg vs. 1 mg) and a 40-week open-label follow-up [5] - The primary efficacy endpoint is the change in CAPS-5 total severity score at Week 8 [5] Commercialization Readiness in TRD - Compass is preparing for the commercialization of COMP360 for TRD, with a focus on ensuring patient access if approved [2][12] - The company has had positive discussions with the FDA regarding its NDA submission strategy for COMP360 in TRD, including potential rolling submission scenarios [5] - The company has also expanded its collaborations to enhance the integration of COMP360 into healthcare settings [5] Financial Updates - Compass has amended its term loan facility with Hercules Capital, increasing it to $150 million, with $50 million already drawn [12] - The amendment extends the interest-only period until at least January 2029, providing financial flexibility [12] About PTSD and TRD - PTSD affects approximately 13 million adults in the U.S. annually, with limited treatment options available [10][8] - TRD impacts around 4 million patients in the U.S., characterized by inadequate response to multiple treatments [13]