Upcoming FDA decision · May 1, 2027
AXS-12 (reboxetine) PDUFA date: FDA decision expected May 1, 2027
260 days to goAxsome Therapeutics, Inc. (AXSM) →
The FDA is expected to decide on AXS-12 (reboxetine) from Axsome Therapeutics, Inc. in Narcolepsy by the PDUFA target action date of May 1, 2027. NDA filing. AI-extracted from news: Axsome signals 1 NDA per year through 2030 as AXS-12 targets May 1, 2027 PDUFA
A PDUFA date is the FDA's target deadline to complete its review of a drug application — approval, a complete response letter (CRL), or an extension are all possible. What is a PDUFA date? This page is research information, not financial advice.
May 1
Target action date
Phase 3
Stage
Verified
Date confidence
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FDA designations