FDA has set April 23, 2026, as the target date for reviewing a submission seeking approval for GTx-104 to treat patients with aneurysmal Subarachnoid Hemorrhage (aSAH). Phase 3 STRIVE-ON Safety Trial data was presented at the 2025 Society of Vascular and Interventional Neurology Annual Meeting. Grace Therapeutics continues pre-commercial planning for potential FDA approval of GTx-104 for aSAH treatment. The company reported financial results for the quarter ended December 31, 2025, including a net loss of $2.3 million. They also secured $4.0 million in additional funding through warrant exercises.

During the third fiscal quarter, the company provided grant support for a Continuing Medical Education (CME) program for healthcare professionals caring for aSAH patients. The STRIVE-ON trial data, presented at the Society of Vascular and Interventional Neurology annual meeting, showed improved outcomes in aSAH patients treated with GTx-104. The company’s financial results for the quarter ended December 31, 2025, included a net loss of $2.3 million. They also secured $4.0 million in additional funding through warrant exercises.

GTx-104 is a novel injectable formulation of nimodipine for IV infusion in aSAH patients. The STRIVE-ON trial demonstrated a 19% reduction in clinically significant hypotension compared to oral nimodipine. GTx-104 has potential benefits in functional outcomes and fewer adverse events. The Company aims for FDA approval and commercial success for GTx-104 to address the unmet medical needs of aSAH patients. Aneurysmal Subarachnoid Hemorrhage (aSAH) occurs when an aneurysm ruptures in the brain, leading to bleeding in the subarachnoid space. This type of stroke accounts for about 5% of all strokes, with an estimated 42,500 U.S. hospital-treated patients.

Grace Therapeutics is a late-stage biopharma company focused on rare and orphan diseases. Their drug delivery technologies aim to enhance drug performance, reduce side effects, and improve drug delivery convenience. GTx-104, their lead clinical asset, targets aSAH and has received Orphan Drug Designation by the FDA. The company’s financial results for the quarter ended December 31, 2025, included a net loss of $2.3 million. They also secured $4.0 million in additional funding through warrant exercises.

Read more at GlobeNewswire: Grace Therapeutics Announces Third Quarter 2026 Financial