COMP360 psilocybin - (COMP006)

May 13, 2026: Compass Pathways plc (NASDAQ: CMPS) reported Q1 2026 results and regulatory/commercial updates for COMP360 (synthetic psilocybin) in treatment-resistant depression (TRD). The FDA granted the company’s request for a rolling NDA submission and review based on positive Phase 3 data; Compass said the rolling submission is underway with sections already submitted, and the final NDA submission remains on track for Q4 2026. Compass also reported it was awarded a Commissioner’s National Priority Review Voucher (CNPV) for COMP360 in TRD, which the company says could shorten FDA review time to 1–2 months after filing. Additional clinical catalyst: 26-week (Part B) data from the COMP006 Phase 3 trial are expected in early Q3 2026. The company said it is preparing for a potential launch by year-end and is supporting federal and state rescheduling efforts.

Financially, Compass reported cash and cash equivalents of $466.0 million as of March 31, 2026 (up from $149.6 million at Dec. 31, 2025) and guided that cash is expected to fund operations into 2028.