Grace Therapeutics Announces Alignment with the FDA Supporting the Planned NDA Submission for GTx-104
FDA Meeting and NDA Submission: Grace Therapeutics announced a productive Type C meeting with the FDA regarding their GTx-104 drug, an injectable formulation of nimodipine for treating aneurysmal subarachnoid hemorrhage (aSAH). The company plans to submit a New Drug Application (NDA) in Q2 2025 based on positive feedback from the FDA.
STRIVE-ON Trial Results: The STRIVE-ON trial demonstrated that GTx-104 significantly reduced clinically significant hypotension compared to oral nimodipine, with better patient outcomes and compliance. The trial's findings support GTx-104 as a promising treatment option for aSAH patients.
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Grace Therapeutics Announces Submission of New Drug Application to U.S. Food and Drug Administration for GTx-104
NDA Submission for GTx-104: Grace Therapeutics has submitted a New Drug Application (NDA) to the FDA for GTx-104, an injectable formulation of nimodipine aimed at treating aneurysmal subarachnoid hemorrhage (aSAH), supported by positive results from the Phase 3 STRIVE-ON safety trial.
Financial Implications and Market Potential: The NDA submission could trigger up to $7.6 million in financing warrants, and GTx-104's Orphan Drug Designation may provide seven years of marketing exclusivity, addressing significant unmet medical needs in aSAH treatment.
