Axsome slips as FDA rejects fibromyalgia drug application, forcing new trial

Axsome Therapeutics

09/06/2025 12:35

** Shares of Axsome Therapeutics AXSM.O fall 4.4% to $107 premarket

** Co says it received a "Refusal to File" letter from the US FDA for its marketing application for AXS-14 to treat fibromyalgia

** The FDA rejected the application because one of the two clinical trials had an 8-week endpoint and used flexible dosing instead of fixed dosing - AXSM

** Co says it will conduct an additional clinical trial with a 12-week endpoint and fixed-dose design as requested by the FDA

** Co plans to start this new trial in Q4 2025

** Fibromyalgia is a chronic condition that causes widespread pain, fatigue, and problems with sleep, memory

** As of last close, stock up 32.3% YTD

(Reporting by Kamal Choudhury in Bengaluru)

((Kamal.Choudhury@thomsonreuters.com;))