FDA refuses to file Axsome's NDA for AXS-14 (esreboxetine) for fibromyalgia; new trial required

Axsome Therapeutics, Inc.

FDA issued RTF letter; second placebo-controlled trial deemed inadequate due to 8-week endpoint and flexible-dose design.
First trial (12-week, fixed-dose) accepted as adequate; both trials met primary endpoints with no efficacy concerns raised.
Axsome will conduct a new fixed-dose, 12-week trial; initiation expected in Q4 2025.
Delay extends approval timeline for potential treatment of ~17 million U.S. fibromyalgia patients.

item 8.01item 9.01

This headline and bullets were generated automatically by deepseek-v4-flash:cloud@v2 from the public filing. Read the source on SEC.gov before relying on any specific claim. Not investment advice. See methodology for how this pipeline works.