Grace Therapeutics announced that Chief Executive Officer Prashant Kohli will present the company's corporate overview and clinical pipeline at the TD Cowen 46th Annual Health Care Conference scheduled for March 4, 2026. The presentation will provide investors and industry participants with an update on the company's strategic initiatives and development programs.
In a concurrent disclosure, the company revealed that the U.S. Food and Drug Administration has established April 23, 2026 as the Prescription Drug User Fee Act (PDUFA) target action date for GTx-104, an intravenous infusion formulation of nimodipine. The drug candidate is under development for the treatment of aneurysmal subarachnoid hemorrhage (aSAH), a severe form of bleeding in the brain. This regulatory milestone marks a key inflection point for the company's lead asset as it advances through the FDA review process.
The PDUFA date provides a defined timeline for the FDA's initial review of GTx-104's new drug application, typically indicating a potential regulatory decision within approximately six months from the announcement date.