Core Viewpoint - Grace Therapeutics has submitted a New Drug Application (NDA) for GTx-104 to the FDA, which is a significant milestone for the company and is supported by positive results from the Phase 3 STRIVE-ON safety trial, indicating potential clinical benefits for patients with aneurysmal subarachnoid hemorrhage (aSAH) [1][2][3] Group 1: NDA Submission and Financial Implications - The NDA submission for GTx-104 could trigger the exercise of up to $7.6 million in warrants from a private placement completed in September 2023, with each warrant exercisable at $3.003 per share [2] - The FDA typically has a 60-day period to assess the completeness of the NDA submission [3] Group 2: Clinical Trial Results - The STRIVE-ON safety trial involved 50 patients receiving GTx-104 and 52 patients receiving oral nimodipine, meeting its primary endpoint with a 19% reduction in clinically significant hypotension incidents for GTx-104 compared to oral nimodipine (28% vs. 35%) [4] - Additional findings showed that 54% of patients on GTx-104 had a relative dose intensity of 95% or higher, compared to only 8% on oral nimodipine, and 29% more patients had favorable functional outcomes at 90 days [4] Group 3: Product and Market Potential - GTx-104 is a novel injectable formulation of nimodipine designed for IV infusion, addressing significant unmet medical needs in aSAH patients [1][7] - The product has been administered to over 200 patients and health volunteers, demonstrating good tolerance and lower pharmacokinetic variability compared to oral nimodipine [8] - GTx-104 has received Orphan Drug Designation from the FDA, which provides seven years of marketing exclusivity upon approval [3][9]
Grace Therapeutics Announces Submission of New Drug Application to U.S. Food and Drug Administration for GTx-104