Grace Therapeutics (GRCE) announced that on August 22, 2025 the U.S. Food and Drug Administration, FDA, accepted the Company’s New Drug Application, NDA, for GTx-104 for formal review. The application seeks approval for GTx-104 for the treatment of patients with aSAH, and is supported by a comprehensive data package including positive data obtained from the Company’s Phase 3 STRIVE-ON safety trial of GTx-104. The FDA established a Prescription Drug User Fee Act, PDUFA, target date of April 23, 2026 for its review of the Company’s NDA submission.
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