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Positive Phase 3 durability and rapid-onset data across two trials, plus a rolling NDA with a clear final submission target and a defined 1H 2027 launch window, create a tangible near-term catalyst for CMPS. Historical analogs show multi-trial positive results paired with NDA milestones often yield outsized moves as FDA decisions approach.
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Compass Pathways reports COMP006 Part B 26-week results for COMP360, reinforcing rapid onset and durable relief in treatment-resistant depression across nearly 600 patients. A 39% MADRS ≥25% response at week 6 and retreatment-associated remission support a potential new standard of care, with rolling NDA submission on track for final submission in Q4 2026 and a possible 1H 2027 launch pending regulatory approval.
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