Compass Pathways has initiated a rolling New Drug Application to the FDA for COMP360 synthetic psilocybin, with the agency granting rolling review and selecting it for the Commissioner's National Priority Voucher pilot program. Traders are pricing approval before March 2027 at 78¢, up from 45¢, as the enhanced designation carries a shortened review window of one to two months following formal NDA filing.

The company now expects a potential approval decision in late 2026 or early 2027, nine to 12 months earlier than previously anticipated, following a "positive" FDA meeting. Compass aims to be the first company approved for a classic psychedelic in the US, supported by data from two Phase III trials enrolling over 1,000 treatment-resistant depression patients. The market implies growing confidence in the FDA's interest in psychedelics, with Health Secretary RFK Jr. and Commissioner Makary both supporting faster development.