PRINCETON, N.J. — November 11, 2025 — Leads & Copy —
Grace Therapeutics, Inc. (Nasdaq: GRCE), a late-stage biopharmaceutical company, announced that an abstract of its Pivotal Phase 3 STRIVE-ON Safety Trial of GTx-104 in aneurysmal subarachnoid hemorrhage (aSAH) has been accepted for presentation at the Society of Vascular and Interventional Neurology (SVIN) annual meeting.
The SVIN annual meeting will be held November 19-22, 2025, in Orlando, FL. Thomas P Bleck, MD, Professor of Neurology at Northwestern University Feinberg School of Medicine, will present the trial results in an oral presentation on November 21, 2025.
The STRIVE-ON trial, also known as NCT05995405, studies GTx-104, a clinical-stage, novel, injectable formulation of nimodipine being developed for IV infusion to address significant unmet medical needs in aSAH patients.
The presentation details are as follows:
- Abstract Number: 697
- Title: Safety and Tolerability of GTX-104 (Nimodipine Injection for IV Infusion) Compared with Oral Nimodipine in Patients with Aneurysmal Subarachnoid Hemorrhage: a Prospective, Randomized Trial
- Session: November 21, 2025, 10:30:00 AM – 12:00 PM
- Presentation: November 21, 2025, 10:55:00 AM – 11:05 AM
Aneurysmal subarachnoid hemorrhage (aSAH) is bleeding over the surface of the brain in the subarachnoid space between the brain and the skull, which contains blood vessels that supply the brain. A primary cause of such bleeding is the rupture of an aneurysm in the brain. aSAH accounts for about 5% of all strokes and an estimated 42,500 U.S. hospital-treated patients.
GTx-104 is a clinical stage, novel, injectable formulation of nimodipine being developed for I.V. infusion in aSAH patients to address significant unmet medical needs. The unique nanoparticle technology of GTx-104 facilitates aqueous formulation of insoluble nimodipine for a standard peripheral I.V. infusion.
GTx-104 provides a convenient I.V. delivery of nimodipine in the Intensive Care Unit, potentially eliminating the need for nasogastric tube administration in unconscious or dysphagic patients. Intravenous delivery of GTx-104 also has the potential to lower food effects, drug-to-drug interactions, and eliminate potential dosing errors. Further, GTx-104 has the potential to better manage hypotension in aSAH patients.
GTx-104 has been administered in over 200 patients and healthy volunteers and was well tolerated with significantly lower inter- and intra-subject pharmacokinetic variability compared to oral nimodipine.
Grace Therapeutics, Inc. is a late-stage biopharma company with drug candidates addressing rare and orphan diseases. Grace Therapeutics’ novel drug delivery technologies have the potential to improve the performance of currently marketed drugs by achieving faster onset of action, enhanced efficacy, reduced side effects, and more convenient drug delivery.
Grace Therapeutics’ lead clinical assets have each been granted Orphan Drug Designation by the FDA, which provides seven years of marketing exclusivity post-launch in the United States, and additional intellectual property protection with over 40 granted and pending patents. Grace Therapeutics’ lead clinical asset, GTx-104, is an I.V. infusion targeting aneurysmal Subarachnoid Hemorrhage (aSAH), a rare and life-threatening medical emergency in which bleeding occurs over the surface of the brain in the subarachnoid space between the brain and skull.
Prashant Kohli, Chief Executive Officer, Tel: 450-686-4555, Email: info@gracetx.com
Mike Moyer, Managing Director, LifeSci Advisors, Phone: 617-308-4306, Email: mmoyer@lifesciadvisors.com
Source: Grace Therapeutics, Inc.
