Compass Pathways plc (CMPS) — In its third-quarter 2025 results, Compass Pathways said a positive Type B meeting with the FDA supports a rolling NDA submission for COMP360 psilocybin in treatment-resistant depression and that it now expects a potential approval decision in late 2026 or early 2027, roughly 9 to 12 months earlier than previously guided.
The company detailed plans to accelerate commercial launch preparations. Shares reacted sharply to the improved regulatory timeline.
Source: businesswire.com
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