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Secures Approximately $4.0 Million through Common Warrant Exercises Following Acceptance of New Drug Application for GTx-104 for formal FDA Review.
Granted Sixth U.S. Patent Covering I.V. Dosing Regimen for GTx-104
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FDA Accepts Grace Therapeutics' GTx-104 for Review, Targets April 23, 2026 for aSAH Drug Decision
Grace Therapeutics Q1 2026 Results and GTx-104 NDA Submission for aSAH Treatment
Announces Submission of New Drug Application to U.S. Food and Drug Administration for GTx-104
Announces 2025 Fiscal Year-End Results, Provides Business Update Held Type C meeting with FDA on Planned New Drug Application (NDA) Submission, Including Clinical, Non-clinical, and Chemistry, Manufacturing, and Control (CMC) Requirements NDA On Track for Submission to FDA in First Half of Calendar 2025 NDA to be Supported by Data from Phase 3 STRIVE-ON Safety Trial, which Met Prima
Announces Alignment with the FDA Supporting the Planned NDA Submission for GTx-104 NDA Submission Anticipated Q2 Calendar 2025
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