Overview
- Compass Pathways reported an adjusted first-quarter loss of $0.30 per share that beat forecasts, and the stock rose about 12% to 14% after the update.
- The FDA granted a rolling New Drug Application for COMP360, a psilocybin therapy for treatment-resistant depression, which lets the agency review sections as they are filed.
- Compass also received a Commissioner’s National Priority Voucher for COMP360, a voucher that could shorten the FDA review once the application is complete, with Jefferies estimating a one to two month timeline.
- Cash reached $466 million after recent financings and warrant exercises, giving runway into 2028, and debt totaled $50.5 million.
- Next catalysts include 26-week durability results from the Phase 3 Part B study in early Q3 2026 and a planned final NDA submission in Q4 2026.