Grace Therapeutics announced that the U.S. FDA accepted their New Drug Application (NDA) for GTx-104 for formal review.
The application aims to treat patients with aneurysmal Subarachnoid Hemorrhage (aSAH) and is supported by positive data from Phase 3 STRIVE-ON Safety Trial.
The FDA set a PDUFA target date of April 23, 2026, for the review process.
FDA Acceptance for Review
FDA accepted Grace Therapeutics' NDA for GTx-104, marking a significant milestone in advancing treatment for aSAH patients.
Data Package Support
Comprehensive data package, including positive results from the STRIVE-ON trial, supports the potential benefit of GTx-104 in aSAH treatment.
Financial Implications
Acceptance of the NDA triggers potential exercise of up to $7.6 million in warrants, providing financial opportunities for Grace Therapeutics.
- The STRIVE-ON safety trial showed promising results for GTx-104 compared to oral nimodipine, indicating improved clinical outcomes and pharmacoeconomic potential.
- GTx-104 demonstrated a reduction in hypotension episodes, higher relative dose intensity, and better functional outcomes at 90 days than oral nimodipine.
Grace Therapeutics' acceptance of the NDA by the FDA and the positive results from the STRIVE-ON trial position GTx-104 as a potential breakthrough in aSAH treatment, offering hope for patients and investors alike.