Core Insights - Grace Therapeutics, Inc. announced positive topline data from its Phase 3 STRIVE-ON safety trial of GTx-104, demonstrating clinical benefits compared to oral nimodipine in patients with aneurysmal Subarachnoid Hemorrhage (aSAH) [1][2] Trial Results - The trial met its primary endpoint, showing a 19% reduction in clinically significant hypotension incidents for patients receiving GTx-104 (28% vs. 35% for nimodipine) [2] - Adverse events were comparable between GTx-104 and nimodipine, with no new safety issues identified [2] - All deaths in the trial were attributed to the severity of the underlying disease, not the treatment [2] Future Plans - A new drug application submission to the US is anticipated in the first half of 2025 [3] - Grace Therapeutics announced a private placement of approximately $30 million, with $15 million upfront and an additional $15 million possible through investor warrants [3][4] Financial Details - The company will issue 4.42 million common shares and warrants at a combined purchase price of $3.395 [4] - The net proceeds from this placement will be used to fund the development of GTx-104 [4] Market Reaction - Following the announcement, GRCE stock increased by 4.32%, reaching $3.38 [4] - A significant 54% of patients receiving GTx-104 achieved a relative dose intensity of 95% or higher, compared to only 8% for nimodipine [4] - There was a 29% relative increase in favorable outcomes at 90 days follow-up on the modified Rankin scale for patients receiving GTx-104 [4] - Patients on GTx-104 experienced fewer ICU readmissions, ICU days, and ventilator days compared to those on nimodipine [4]
Small-Cap Grace Therapeutics Touts Positive Data From Brain Hemorrhage Study