Grace Therapeutics Announces Abstract Accepted for Presentation at Society of Vascular and Interventional Neurology Annual Meeting
Grace Therapeutics (Nasdaq: GRCE) announced that an abstract from its Pivotal Phase 3 STRIVE-ON safety trial of GTx-104 (nimodipine injection for IV infusion) was accepted as a late-breaking presentation at the Society of Vascular and Interventional Neurology annual meeting, Nov 19-22, 2025 in Orlando, FL.
Dr. Thomas P. Bleck will present oral results on Nov 21, 2025 at 10:55 AM (Abstract No. 697). The randomized trial (NCT05995405) compares safety and tolerability of GTx-104 versus oral nimodipine in aneurysmal subarachnoid hemorrhage (aSAH) patients. aSAH accounts for ~5% of strokes with an estimated 42,500 U.S. hospital-treated patients.
Grace Therapeutics (Nasdaq: GRCE) ha annunciato che un abstract dal suo trial di Fase 3 Pivotal STRIVE-ON sulla sicurezza di GTx-104 (iniezione di nimodipina per infusione endovenosa) è stato accettato come presentazione di grande attualità alla conferenza annuale della Society of Vascular and Interventional Neurology, dal 19 al 22 novembre 2025 a Orlando, FL.
Il Dr. Thomas P. Bleck presenterà i risultati orali il 21 novembre 2025 alle 10:55 (Abstract No. 697). Il trial randomizzato (NCT05995405) confronta sicurezza e tollerabilità di GTx-104 rispetto alla nimodipina orale nei pazienti con emorragia subaracnoidea aneurysmatica (aSAH). L'aSAH rappresenta circa il 5% degli ictus con potenziali 42.500 pazienti trattati in ospedale negli Stati Uniti.
Grace Therapeutics (Nasdaq: GRCE) anunció que un resumen de su ensayo pivotal de Fase 3 STRIVE-ON sobre seguridad de GTx-104 (inyección de nimodipina para infusión IV) fue aceptado como presentación de última hora en la reunión anual de la Society of Vascular and Interventional Neurology, del 19 al 22 de noviembre de 2025 en Orlando, FL.
El Dr. Thomas P. Bleck presentará resultados orales el 21 de noviembre de 2025 a las 10:55 AM (Abstract No. 697). El ensayo aleatorizado (NCT05995405) compara la seguridad y tolerabilidad de GTx-104 frente a nimodipina oral en pacientes con hemorragia subaracnoidea aneurismal (aSAH). La aSAH representa cerca del 5% de los accidentes vasculares cerebrales, con un estimado de 42,500 pacientes tratados en hospitales de EE. UU.
Grace Therapeutics (나스닥: GRCE)는 GTx-104 (정맥 주입용 니모디핀)의 안전성 평가를 위한 주요 3상 STRIVE-ON 연구의 초록이 2025년 11월 19-22일 플로리다주 올랜도에서 열리는 뇌혈관 및 중재신경학회 연차대회에서 Late-Breaking 발표로 채택되었다고 발표했다.
Dr. Thomas P. Bleck은 2025년 11월 21일 오전 10:55에 구두 발표를 할 예정이며(Abstract No. 697). 무작위 시험(NCT05995405)은 뇌동맥류성 뇌출혈(aSAH) 환자에서 GTx-104와 경구 니모디핀의 안전성 및 내약성을 비교한다. aSAH는 약 발생의 5%에 해당하며 미국 내 병원 치료 후보자는 약 42,500명으로 추정된다.
Grace Therapeutics (Nasdaq: GRCE) a annoncé qu'un résumé de son essai pivôt de phase 3 STRIVE-ON sur la sécurité de GTx-104 (injection de nimodipine pour perfusion IV) a été accepté comme présentation de dernière minute lors de la réunion annuelle de la Society of Vascular and Interventional Neurology, du 19 au 22 novembre 2025 à Orlando, en Floride.
Le Dr Thomas P. Bleck présentera les résultats oraux le 21 novembre 2025 à 10h55 (Abstract No. 697). L'essai randomisé (NCT05995405) compare la sécurité et la tolérance de GTx-104 à la nimodipine orale chez des patients souffrant d'hémorragie subarachnoïdale aneurysmale (aSAH). L'aSAH représente environ 5% des accidents vasculaires cérébraux, avec environ 42 500 patients pris en charge à l'hôpital aux États-Unis.
Grace Therapeutics (Nasdaq: GRCE) gab bekannt, dass ein Abstract aus ihrem Pivotal Phase-3-STRIVE-ON-Sicherheits- trial von GTx-104 (Nimodipin-Injektion für intravenöse Infusion) als Late-Breaking- Präsentation auf der Jahrestagung der Society of Vascular and Interventional Neurology akzeptiert wurde, vom 19. bis 22. November 2025 in Orlando, FL.
Dr. Thomas P. Bleck wird die mündlichen Ergebnisse am 21. November 2025 um 10:55 Uhr vorstellen (Abstract Nr. 697). Die randomisierte Studie (NCT05995405) vergleicht Sicherheit und Verträglichkeit von GTx-104 im Vergleich zu oraler Nimodipin bei Patienten mit aneurysmaler Subarachnoidalblutung (aSAH). Die aSAH macht ca. 5% der Schlaganfälle aus, mit geschätzten 42.500 hospitalisierten Patienten in den USA.
Grace Therapeutics (ناسداك: GRCE) أعلنت أن Abstract من تجربتها الحاسمة في المرحلة الثالثة STRIVE-ON حول السلامة لـ GTx-104 (حقن النيموديبين للحقن الوريدي) تم قبوله كعرض متأخر كسرعة في اجتماع الجمعية الوطنية للأعصاب الوعائية والتداخلية السنوي، من 19-22 نوفمبر 2025 في أورلاندو، فلوريدا.
سيقدم الدكتور توماس P. Bleck النتائج الشفوية في 21 نوفمبر 2025 الساعة 10:55 صباحاً (Abstract No. 697). تقارن الدراسة العشوائية (NCT05995405) السلامة والتحمل لـ GTx-104 مقابل النيموديبين الفموي لدى مرضى نزف تحت العنكبوتية الناتج عن تمدد الشريان. يمثل aSAH نحو حوالي 5% من السكتات الدماغية مع تقدير 42,500 مريضاً يخضعون للعلاج في المستشفيات الأمريكية.
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STRIVE-ON Results Accepted for Late-Breaking Presentation
PRINCETON, N.J., Nov. 11, 2025 (GLOBE NEWSWIRE) -- Grace Therapeutics, Inc. (Nasdaq: GRCE) (Grace Therapeutics or the Company), a late-stage, biopharma company advancing GTx-104, a clinical-stage, novel, injectable formulation of nimodipine being developed for IV infusion to address significant unmet medical needs in aneurysmal subarachnoid hemorrhage (aSAH) patients, today announced that an abstract of the Company’s Pivotal Phase 3 STRIVE-ON Safety Trial of GTx-104 in aSAH (the STRIVE-ON trial–NCT05995405) has been accepted for presentation as a late breaking trial at the Society of Vascular and Interventional Neurology (SVIN) annual meeting, to be held November 19-22, 2025 in Orlando, FL.
Thomas P Bleck, MD, Professor, Neurology (Neurocritical Care and Epilepsy/Clinical Neurophysiology) at Northwestern University Feinberg School of Medicine, will present results of the trial in an oral presentation held November 21, 2025.
Presentation Details
| 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: 11/21/2025 10:30:00 AM - 12:00 PM | |
| Presentation: 11/21/2025 10:55:00 AM - 11:05 AM | |
About aneurysmal Subarachnoid Hemorrhage (aSAH)
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. The result is a relatively uncommon type of stroke (aSAH) that accounts for about
About GTx-104
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.
About Grace Therapeutics
Grace Therapeutics, Inc. (Grace Therapeutics or the Company) 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.
For more information, please visit: www.gracetx.com
For more information, please contact:
Grace Therapeutics Contact:
Prashant Kohli
Chief Executive Officer
Tel: 450-686-4555
Email: info@gracetx.com
www.gracetx.com
Investor Relations:
LifeSci Advisors
Mike Moyer
Managing Director
Phone: 617-308-4306
Email: mmoyer@lifesciadvisors.com
FAQ
What will Grace Therapeutics (GRCE) present at SVIN on November 21, 2025?
What is the STRIVE-ON trial NCT number for GRCE's Phase 3 study?
Who will present Grace Therapeutics' STRIVE-ON results at the SVIN meeting?
What endpoints are being compared in the STRIVE-ON Phase 3 trial (GRCE)?
When and where is the SVIN annual meeting where GRCE will present STRIVE-ON results?
How common is aneurysmal subarachnoid hemorrhage (aSAH) mentioned in the GRCE release?
