Grace Therapeutics, Inc. announced FDA acceptance for review of the New Drug Application (NDA) for GTx-104 to treat aneurysmal Subarachnoid Hemorrhage (aSAH) with a PDUFA target date of April 23, 2026. Phase 3 STRIVE-ON safety trial data was presented at the 2025 Neurocritical Care Annual Meeting. A sixth U.S. patent covering the IV dosing regimen for GTx-104 was granted.

During Q2 2026, Grace Therapeutics reached significant milestones with FDA review acceptance for GTx-104 NDA for aSAH treatment. Positive results from the STRIVE-ON trial were highlighted at a medical meeting. They also received a new patent for IV dosing regimen. Financially, they secured $4.0 million in additional funding. Cash and cash equivalents were $16.9 million as of September 30, 2025.

In Q2 2026, Grace Therapeutics reported a net loss of $0.9 million, decreased from $3.4 million in Q2 2025. Research and development expenses decreased by $2.4 million, while general and administrative expenses increased by $0.1 million. Cash and cash equivalents stood at $16.9 million as of September 30, 2025, down from $22.1 million on March 31, 2025.

Grace Therapeutics’ GTx-104 is a novel IV infusion for aSAH patients with unique nanoparticle technology. The STRIVE-ON trial demonstrated a 19% reduction in clinically significant hypotension compared to oral nimodipine. GTx-104 had favorable outcomes, including higher dose intensity and more patients with positive functional outcomes at 90 days. Adverse events were comparable between GTx-104 and oral nimodipine.

aSAH is a type of stroke caused by bleeding over the brain’s surface due to an aneurysm rupture. Grace Therapeutics’ GTx-104 aims to address the significant unmet medical needs in aSAH patients. GTx-104 offers IV delivery of nimodipine, potentially improving patient outcomes by eliminating dosing errors and managing hypotension better. It could provide a much-needed innovation in aSAH treatment.

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