Company Overview - Grace Therapeutics, Inc. (formerly Acasti Pharma Inc.) is a late-stage biopharma company focused on developing innovative drug delivery technologies for rare and orphan diseases [7] - The company's lead clinical asset, GTx-104, is an injectable formulation of nimodipine aimed at treating aneurysmal subarachnoid hemorrhage (aSAH) [5][7] Product Development - GTx-104 is designed for intravenous infusion to address significant unmet medical needs in aSAH patients, potentially improving treatment outcomes compared to oral formulations [5][6] - The unique nanoparticle technology of GTx-104 allows for a standard peripheral IV infusion, which may eliminate the need for nasogastric tube administration in unconscious or dysphagic patients [6] - GTx-104 has been administered to over 150 healthy volunteers and demonstrated good tolerance with lower pharmacokinetic variability compared to oral nimodipine [6] Market Context - Aneurysmal subarachnoid hemorrhage (aSAH) is a rare and life-threatening condition that accounts for approximately 5% of all strokes, with an estimated 42,500 hospital-treated patients in the U.S. [4] - The company hosted a virtual key opinion leader (KOL) event discussing the high unmet medical need and current treatment landscape for aSAH patients [2] Regulatory and Commercial Strategy - Grace Therapeutics has received Orphan Drug Designation from the FDA for its lead clinical assets, providing seven years of marketing exclusivity post-launch in the U.S. [7] - The company holds over 40 granted and pending patents, enhancing its intellectual property protection [7] Upcoming Events - The CEO of Grace Therapeutics, Prashant Kohli, will participate in the TD Cowen 45th Annual Health Care Conference on March 4, 2025, to discuss the company's developments [1][2]
Grace Therapeutics to Participate in the TD Cowen 45th Annual Health Care Conference