AXS-12 (reboxetine) PDUFA date: FDA decision expected May 1, 2027
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.
Source: seekingalpha.com · Data checked November 12, 2026. How we check dates. Confirm dates against the company's or the FDA's announcement before acting.
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Questions about this FDA decision
- When is the PDUFA date for AXS-12 (reboxetine)?
- The FDA's PDUFA target action date for AXS-12 (reboxetine) is May 1, 2027. The FDA can act before that date, and the review can be extended.
- What is AXS-12 (reboxetine) being reviewed for?
- The application under FDA review covers Narcolepsy.
- Which company is developing AXS-12 (reboxetine)?
- Axsome Therapeutics, Inc. (AXSM).
- What can happen on a PDUFA date?
- The FDA approves the application, issues a complete response letter (CRL) listing what must be fixed before approval, or extends the review (typically by three months after a major amendment).