Company Overview - Grace Therapeutics, Inc. is a late-stage biopharma company focused on developing GTx-104, a novel injectable formulation of nimodipine for I.V. infusion targeting aneurysmal subarachnoid hemorrhage (aSAH) [6] - The company has received Orphan Drug Designation from the FDA for its lead clinical asset, GTx-104, which provides seven years of marketing exclusivity post-launch in the U.S. [6] Funding and Financials - The company secured approximately $4.0 million in additional funding through the exercise of common warrants, issuing 1,345,464 new shares at an exercise price of $3.003 per share [1] - The remaining 1,190,927 common warrants from the 2023 private placement have expired following the FDA's acceptance for review of the NDA for GTx-104 [1] Product Development - GTx-104 is being developed to address significant unmet medical needs in aSAH patients, with a PDUFA target date set by the FDA for April 23, 2026, for the NDA review [2] - The NDA submission is supported by positive data from the Phase 3 STRIVE-ON safety trial of GTx-104 [2] Medical Context - aSAH is a type of stroke caused by the rupture of an aneurysm, accounting for about 5% of all strokes, with an estimated 42,500 hospital-treated patients in the U.S. annually [3] - GTx-104 aims to provide a convenient I.V. delivery method, potentially eliminating the need for nasogastric tube administration in unconscious or dysphagic patients, and has been administered to over 200 patients and healthy volunteers [5] Technology and Advantages - GTx-104 utilizes unique nanoparticle technology to facilitate the aqueous formulation of insoluble nimodipine for standard peripheral I.V. infusion [4] - The intravenous delivery of GTx-104 may lower food effects, drug-to-drug interactions, and dosing errors, while better managing hypotension in aSAH patients [5]
Grace Therapeutics Secures Approximately $4.0 Million through Common Warrant Exercises Following Acceptance of New Drug Application for GTx-104 for formal FDA Review