FDA grants Compass rolling NDA review and a National Priority Voucher for COMP360

Compass Pathways plc (CMPS) — Compass Pathways said the FDA granted its request for rolling review of the COMP360 psilocybin NDA and selected the program for the Commissioner's National Priority Voucher (CNPV) program in treatment-resistant depression.

The voucher promises enhanced FDA communication and a compressed one-to-two-month review after filing. Compass is targeting a rolling NDA submission in Q4 2026, and the designation materially raises the odds of an earlier approval decision.

Source: ir.compasspathways.com

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