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AXSM biotech catalysts & pipeline

AXSOME THERAPEUTICS INC · Data as of 2026-09-08

Upcoming catalysts

solriamfetol — Topline data

Q4 2026

The Company anticipates topline results from the ENGAGE Phase 3 trial in the fourth quarter of 2026.
Source filing

solriamfetol — Topline data

2027

The Company anticipates topline results from the SUSTAIN Phase 3 trial in 2027.
Source filing

reboxetine (AXS-12) — PDUFA

May 1

Narcolepsy: Axsome's NDA submission for AXS-12 for the treatment of cataplexy in narcolepsy was accepted by the FDA and assigned a PDUFA target action date of May 1, 2027.
Source filing

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