Compass Pathways shares rise 11.43% intraday after positive FDA meeting accelerates COMP360 launch by 9-12 months.

Wednesday, Nov 5, 2025 9:36 am ET1min read
Compass Pathways surged 11.43% intraday following the announcement of a 9-12 month acceleration in commercial launch plans for its psilocybin therapy COMP360 in treatment-resistant depression (TRD). The company cited completion of its COMP006 Phase 3 trial enrollment and a positive FDA meeting on NDA submission strategies, including a potential rolling submission, as key drivers. The news highlighted regulatory momentum, with the FDA's openness to expedited pathways and data readouts from pivotal trials expected in early 2026. These developments, coupled with Compass’s updated commercial readiness timeline, signaled progress toward potential market approval, boosting investor confidence. The stock’s sharp intraday rise aligned with the positive clinical and regulatory updates, underscoring market optimism for the psychedelic-based therapy’s commercial prospects.

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