Core Viewpoint - The FDA has accepted Grace Therapeutics' New Drug Application (NDA) for GTx-104, targeting a Prescription Drug User Fee Act (PDUFA) date of April 23, 2026, for the treatment of aneurysmal Subarachnoid Hemorrhage (aSAH) patients, supported by positive results from the Phase 3 STRIVE-ON safety trial [1][2][3] Company Overview - Grace Therapeutics, Inc. is a late-stage biopharma company focused on developing innovative treatments for rare and orphan diseases, with GTx-104 as its lead clinical asset [9] - The company has received Orphan Drug Designation for GTx-104, which provides seven years of marketing exclusivity in the U.S. upon FDA approval [3] Product Details - GTx-104 is a novel injectable formulation of nimodipine designed for IV infusion in aSAH patients, addressing significant unmet medical needs [7][8] - The unique nanoparticle technology of GTx-104 allows for a standard peripheral IV infusion, potentially improving patient outcomes and convenience [8] Clinical Trial Insights - The STRIVE-ON safety trial involved 102 patients, comparing GTx-104 with oral nimodipine, and demonstrated a 19% reduction in clinically significant hypotension incidents for GTx-104 [4] - Additional findings showed that 54% of GTx-104 patients achieved a relative dose intensity of 95% or higher, compared to only 8% for oral nimodipine [4] - GTx-104 also resulted in fewer ICU readmissions and days compared to oral nimodipine, with comparable adverse events between both treatment arms [4] Market Potential - The standard of care for aSAH has not seen significant innovation in nearly 40 years, positioning GTx-104 as a potential breakthrough treatment if approved [2] - The company believes that its patent estate will protect the market value of GTx-104 beyond the exclusivity period provided by the Orphan Drug Designation [3]
Grace Therapeutics Announces U.S. Food and Drug Administration Acceptance for Review of New Drug Application for GTx-104