FDA Accepts Grace Therapeutics’ NDA for GTx-104 in Aneurysmal Subarachnoid Hemorrhage

Grace Therapeutics, Inc., announced that the U.S. Food and Drug Administration (FDA) has accepted the company’s New Drug Application (NDA) for GTx-104, its novel injectable formulation of nimodipine for aneurysmal subarachnoid hemorrhage (aSAH). The NDA is supported by positive results from the Phase 3 STRIVE-ON safety trial, with the FDA setting a Prescription Drug User Fee Act (PDUFA) target date of April 23, 2026.

“FDA acceptance for review of our NDA for GTx-104 for the treatment of aSAH is another significant milestone for Grace Therapeutics, further demonstrating our ability to execute as we continue to advance this important innovation for aSAH patients. Our NDA is supported by a robust data package including positive results from our STRIVE-ON trial, which provides support for improved clinical outcomes in aSAH patients and both medical and pharmacoeconomic evidence of the potential benefit of GTx-104 in the treatment of aSAH. The standard of care for aSAH has not seen meaningful innovation in nearly 40 years, and we believe these results point to a very promising role for GTx-104, if approved, as a potential breakthrough for the care of aSAH patients. We look forward to engaging with the FDA during their review process,” said Prashant Kohli, Chief Executive Officer of Grace Therapeutics. 

The FDA’s acceptance also activates the potential exercise of up to $7.6 million in warrants issued during a September 2023 private placement. Each warrant is exercisable for one share of common stock at $3.003 per share and will expire either 60 days after the NDA acceptance date or by September 25, 2028, whichever comes first.

Grace previously secured Orphan Drug Designation for GTx-104, granting seven years of U.S. marketing exclusivity upon approval. Coupled with its U.S. and international patent portfolio, the company believes these protections will sustain the commercial value of GTx-104 well beyond regulatory exclusivity.