GRCE

In the past six months, the FDA accepted the New Drug Application (NDA) for GTx-104 for formal review, setting a PDUFA target date of April 23, 2026. Data from the Phase 3 STRIVE-ON safety trial for GTx-104 was presented at the Society of Vascular and Interventional Neurology Annual Meeting. Grace Therapeutics announced its Third Quarter 2026 Financial Results and participated in the TD Cowen 46th Annual Health Care Conference. The company announced plans to present data on GTx-104 at upcoming medical conferences, and an abstract highlighting the STRIVE-ON Phase 3 trial results was accepted for presentation at AAN 2026. The FDA issued a Complete Response Letter (CRL) for the GTx-104 NDA, citing issues in the Chemistry, Manufacturing, and Controls (CMC) and non-clinical sections of the application, leading to a significant drop in the stock price. Analysts from Craig-Hallum and TD Cowen lowered their price targets for Grace Therapeutics stock following the FDA's decision.