From Yahoo Finance: 2025-06-11 19:57:00

Axsome Therapeutics, Inc. (NASDAQ:AXSM) receives a Refusal to File letter from the FDA for its new drug application, AXS-14. The submission was incomplete due to an 8-week primary endpoint in a trial and flexible dosing. Analysts anticipate a new 12-week trial with a fixed dose. Stock rated overweight with a price target of $190.

Despite the setback, AXS-14’s regulatory issues are seen as temporary. AXS-05 for Alzheimer’s disease and Auvelity’s commercial success are expected to drive Axsome Therapeutics, Inc. (NASDAQ:AXSM)’s value in 2025. The company remains optimistic about its pipeline and near-term revenue growth.

Axsome Therapeutics, Inc. (NASDAQ:AXSM) is a clinical-stage biopharmaceutical company focused on developing treatments for CNS conditions. The company is among the stocks with the highest upside potential in the market. Analysts believe in the company’s overall pipeline momentum despite recent regulatory challenges.



Read more at Yahoo Finance: Axsome’s AXS-14 Gets Regulatory Setback with RTF, says Morgan Stanley