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

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