Traders are pricing near-certainty that Compass Pathways' COMP360 psilocybin therapy will receive FDA approval before July 2027, with the market jumping from 36¢ to 99¢. This dramatic swing follows the FDA granting Compass a rolling NDA review request and selecting COMP360 for the Commissioner's National Priority Voucher program, which entitles companies to enhanced communications and a shortened 1-2 month review time.

The regulatory fast-track comes after Compass achieved two consecutive positive Phase 3 trials for COMP360 psilocybin therapy in treatment-resistant depression, hitting primary endpoints with high statistical significance in both COMP005 and COMP006. The company now targets a rolling NDA submission in Q4 2026, with a potential FDA approval decision by late 2026 or early 2027. If approved, COMP360 would be the first psilocybin therapy on the market, representing a watershed moment for psychedelic medicine.