Grace Therapeutics Announces FDA Acceptance of NDA for GTx-104 Approval

Grace Therapeutics has announced that the FDA has accepted its New Drug Application for GTx-104, a novel injectable formulation of nimodipine for IV infusion. The FDA has set a target review date of April 23, 2026. The application is supported by positive results from the Phase 3 STRIVE-ON safety trial of GTx-104, which aims to treat patients with aneurysmal subarachnoid hemorrhage.

Grace Therapeutics, Inc. (NASDAQ: GRCE) has announced that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for GTx-104, a novel injectable formulation of nimodipine for treating aneurysmal Subarachnoid Hemorrhage (aSAH). The FDA has set a Prescription Drug User Fee Act (PDUFA) target date of April 23, 2026 for the review of the application. The NDA submission is supported by positive results from the Phase 3 STRIVE-ON safety trial, which demonstrated both clinical and pharmacoeconomic benefits [1].

GTx-104, an IV infusion of nimodipine, addresses a critical unmet medical need in aSAH patients. The FDA's acceptance of the NDA marks a significant regulatory milestone towards potential approval for an innovative aSAH treatment, which has seen no meaningful innovation in nearly four decades. The acceptance triggers the potential exercise of warrants worth $7.6 million at $3.003 per share, issued during a September 2023 private placement [1].

The FDA's acceptance of the NDA for GTx-104 also signifies regulatory confidence in the completeness of Grace Therapeutics' submission package. However, final approval remains contingent on a comprehensive review process evaluating safety, efficacy, manufacturing, and labeling requirements. Grace Therapeutics has secured Orphan Drug Designation for GTx-104, which provides seven years of marketing exclusivity upon approval in the U.S. This regulatory protection, combined with the company's patent estate, creates significant potential market protection beyond the exclusivity period [1].

The STRIVE-ON safety trial, which involved 102 patients, showed that GTx-104 reduced the incidence of clinically significant hypotension by 19% compared to oral nimodipine. Additionally, more patients receiving GTx-104 had favorable functional outcomes at 90 days and experienced fewer ICU readmissions, ICU days, and ventilator days [1].

Grace Therapeutics' innovative drug delivery technology has the potential to improve the performance of currently marketed drugs by achieving faster onset of action, enhanced efficacy, reduced side effects, and more convenient drug delivery. The company's lead clinical asset, GTx-104, is an IV infusion targeting aneurysmal Subarachnoid Hemorrhage (aSAH), a rare and life-threatening medical emergency [1].

References:
[1] https://www.stocktitan.net/news/GRCE/grace-therapeutics-announces-u-s-food-and-drug-administration-9uzcfp2goky2.html