Core Insights - The U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for GTx-104, targeting aneurysmal Subarachnoid Hemorrhage (aSAH), with a PDUFA target date set for April 23, 2026 [1][2][3] - GTx-104 is a novel injectable formulation of nimodipine, developed for intravenous infusion, addressing significant unmet medical needs in aSAH patients [1][14] - The Phase 3 STRIVE-ON trial demonstrated positive results, showing improved clinical outcomes and potential pharmacoeconomic benefits for patients treated with GTx-104 compared to oral nimodipine [2][11] Company Highlights - The FDA's acceptance of the NDA for GTx-104 marks a significant milestone for the company, showcasing its ability to execute clinical and corporate goals [2][3] - The company has secured approximately $4.0 million in additional funding through the exercise of common warrants, enhancing its financial position [3][9] - As of October 31, 2025, the company reported cash and cash equivalents of approximately $20.0 million, indicating a solid cash runway [4][10] Financial Performance - For the quarter ended September 30, 2025, the company reported a net loss of $0.9 million, a decrease from a net loss of $3.4 million in the same period of the previous year [5][22] - Research and development expenses significantly decreased to $0.6 million from $3.0 million year-over-year, primarily due to the completion of the STRIVE-ON trial [6][23] - General and administrative expenses increased slightly to $2.0 million, attributed to pre-commercial planning for GTx-104 [7][23] Intellectual Property - The company was granted a new U.S. patent covering the IV dosing regimen for GTx-104, extending its intellectual property protection to 2043 [2][3] - Grace Therapeutics has established a multi-layered intellectual property estate for GTx-104, including five patents on the formulation, providing protection until 2037 [3][17] STRIVE-ON Trial Insights - The STRIVE-ON trial involved 102 patients, comparing GTx-104 with oral nimodipine, and met its primary endpoint with a 19% reduction in clinically significant hypotension incidents [11] - Secondary outcomes favored GTx-104, with 54% of patients achieving a relative dose intensity of 95% or higher compared to only 8% on oral nimodipine [11] - The trial results were well received at the Neurocritical Care annual meeting, highlighting the potential of GTx-104 in improving treatment for aSAH patients [2][3]
Grace Therapeutics Announces Second Quarter 2026 Financial Results, Provides Business Update