Compass Pathways is trading at $14.40 (+8.2%) in pre-market, extending a strong multi-day rebound driven by significant regulatory progress for its COMP360 program.
- The FDA has accepted an Investigational New Drug (IND) application for a Phase 2b/3 trial of COMP360 in PTSD.
- The company has initiated a rolling New Drug Application (NDA) for treatment-resistant depression, utilizing a National Priority Review Voucher to accelerate the process.
- These milestones materially improve the companyβs regulatory outlook and clinical momentum in a highly news-driven year.