COMPASS Pathways plc - 8-K Filing
Compass Pathways announced positive 26-week results from its Phase 3 COMP006 trial of COMP360 for treatment-resistant depression (TRD), showing a durable response in nearly 40% of participants receiving the 25 mg dose. The data support prior findings and suggest potential benefits from retreatment, with no new safety concerns observed. A rolling NDA submission is underway, on track for completion by Q4 2026, with an anticipated launch in H1 2027 pending FDA approval and DEA rescheduling. (Items: 7.01 of this Current Report on Form 8-K, including Exhibit 99)
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