Grace Therapeutics Announces Submission of New Drug Application to U.S. Food and Drug Administration for GTx-104
Grace Therapeutics (NASDAQ:GRCE) has submitted a New Drug Application (NDA) to the FDA for GTx-104, a novel injectable formulation of nimodipine for treating aneurysmal Subarachnoid Hemorrhage (aSAH). The submission includes positive results from the Phase 3 STRIVE-ON safety trial, where GTx-104 met its primary endpoint and demonstrated clinical benefits compared to oral nimodipine.
The NDA submission could trigger up to $7.6 million in warrant exercises from the company's 2023 financing at $3.003 per share. Grace has secured Orphan Drug Designation for GTx-104, potentially providing 7 years of marketing exclusivity upon FDA approval. The FDA has a 60-day period to determine if the NDA is complete and acceptable for filing.
Grace Therapeutics (NASDAQ:GRCE) ha presentato una New Drug Application (NDA) alla FDA per GTx-104, una nuova formulazione iniettabile di nimodipina destinata al trattamento dell'Emorragia Subaracnoidea aneurismatica (aSAH). La domanda include risultati positivi dallo studio di sicurezza di Fase 3 STRIVE-ON, in cui GTx-104 ha raggiunto l'endpoint primario e ha mostrato benefici clinici rispetto alla nimodipina orale.
La presentazione della NDA potrebbe generare fino a 7,6 milioni di dollari in esercizi di warrant legati al finanziamento del 2023 della società, a un prezzo di 3,003 dollari per azione. Grace ha ottenuto la Designazione di Farmaco Orfano per GTx-104, che potrebbe garantire 7 anni di esclusiva di mercato dopo l'approvazione FDA. La FDA ha un periodo di 60 giorni per valutare se la NDA sia completa e accettabile per la revisione.
Grace Therapeutics (NASDAQ:GRCE) ha presentado una Solicitud de Nuevo Medicamento (NDA) a la FDA para GTx-104, una nueva formulación inyectable de nimodipina para el tratamiento de la Hemorragia Subaracnoidea aneurismática (aSAH). La presentación incluye resultados positivos del ensayo de seguridad de fase 3 STRIVE-ON, donde GTx-104 cumplió con su objetivo principal y mostró beneficios clínicos en comparación con la nimodipina oral.
La presentación de la NDA podría generar hasta 7.6 millones de dólares en ejercicios de warrants derivados del financiamiento de la compañía en 2023, a un precio de 3.003 dólares por acción. Grace ha obtenido la Designación de Medicamento Huérfano para GTx-104, lo que podría proporcionar 7 años de exclusividad en el mercado tras la aprobación de la FDA. La FDA dispone de un período de 60 días para determinar si la NDA está completa y es aceptable para su revisión.
Grace Therapeutics (NASDAQ:GRCE)는 동맥류성 지주막하 출혈(aSAH) 치료를 위한 새로운 주사제 형태의 니모디핀인 GTx-104에 대해 FDA에 신약 신청서(NDA)를 제출했습니다. 이번 제출에는 3상 STRIVE-ON 안전성 시험에서 GTx-104가 주요 평가변수를 충족하고 경구용 니모디핀 대비 임상적 이점을 입증한 긍정적인 결과가 포함되어 있습니다.
NDA 제출은 2023년 회사 자금 조달 당시 주당 3.003달러에 최대 760만 달러 상당의 워런트 행사를 촉발할 수 있습니다. Grace는 GTx-104에 대해 희귀의약품 지정(Orphan Drug Designation)을 확보하여 FDA 승인 시 7년간의 시장 독점권을 받을 수 있습니다. FDA는 NDA가 완전하고 접수 가능한지 여부를 판단하기 위해 60일의 기간을 가집니다.
Grace Therapeutics (NASDAQ:GRCE) a soumis une demande d'autorisation de mise sur le marché (NDA) à la FDA pour GTx-104, une nouvelle formulation injectable de nimodipine destinée au traitement de l'hémorragie sous-arachnoïdienne anévrismale (aSAH). Le dossier comprend des résultats positifs de l'essai de sécurité de phase 3 STRIVE-ON, où GTx-104 a atteint son critère principal et a démontré des bénéfices cliniques par rapport à la nimodipine orale.
La soumission de la NDA pourrait entraîner jusqu'à 7,6 millions de dollars d'exercices de bons de souscription issus du financement de la société en 2023, au prix de 3,003 dollars par action. Grace a obtenu la désignation de médicament orphelin pour GTx-104, offrant potentiellement 7 ans d'exclusivité commerciale après approbation par la FDA. La FDA dispose d'un délai de 60 jours pour déterminer si la NDA est complète et recevable.
Grace Therapeutics (NASDAQ:GRCE) hat einen Antrag auf Zulassung eines neuen Medikaments (NDA) bei der FDA für GTx-104 eingereicht, eine neuartige injizierbare Formulierung von Nimodipin zur Behandlung der aneurysmatischen Subarachnoidalblutung (aSAH). Die Einreichung umfasst positive Ergebnisse der Phase-3-Sicherheitsstudie STRIVE-ON, in der GTx-104 den primären Endpunkt erreichte und klinische Vorteile gegenüber oralem Nimodipin zeigte.
Die NDA-Einreichung könnte bis zu 7,6 Millionen US-Dollar aus der Ausübung von Warrants aus der Finanzierung des Unternehmens im Jahr 2023 zu je 3,003 US-Dollar pro Aktie auslösen. Grace hat für GTx-104 die Orphan-Drug-Zulassung erhalten, die nach FDA-Zulassung 7 Jahre Marktexklusivität bieten könnte. Die FDA hat eine Frist von 60 Tagen, um zu entscheiden, ob die NDA vollständig und zur Prüfung geeignet ist.
- Successful completion and submission of NDA for GTx-104
- Positive Phase 3 STRIVE-ON trial results meeting primary endpoint
- Potential $7.6 million in warrant proceeds upon FDA acceptance
- Secured Orphan Drug Designation with 7 years marketing exclusivity
- Patent protection extending beyond marketing exclusivity period
- None.
Insights
Grace's NDA submission for GTx-104 marks a significant regulatory milestone with potential $7.6M funding catalyst if accepted for review.
This NDA submission represents a critical regulatory milestone for Grace Therapeutics' GTx-104, an injectable nimodipine formulation targeting aneurysmal subarachnoid hemorrhage (aSAH). The submission is backed by positive Phase 3 STRIVE-ON safety trial results, where the drug met its primary endpoint and demonstrated clinical benefits compared to oral nimodipine.
The regulatory and financial implications are significant. FDA typically has a 60-day review period to determine if the NDA is complete and acceptable for filing. If accepted, this would trigger the exercise of warrants worth up to
Grace has secured Orphan Drug Designation for GTx-104, which provides seven years of marketing exclusivity in the US upon approval. This exclusivity, combined with the company's patent estate, creates a substantial market protection strategy. The targeted indication represents an area with limited innovation – the standard of care for aSAH hasn't seen meaningful advancement in nearly 40 years, positioning GTx-104 as a potential breakthrough therapy in an underserved market with established clinical need.
Submission Seeks Approval of GTx-104 in the Treatment of Patients with aneurysmal Subarachnoid Hemorrhage (aSAH)
Comprehensive Data Package Includes Positive Results from Phase 3 STRIVE-ON Safety Trial of GTx-104
Submission Has the Potential to Trigger Exercise of up to
PRINCETON, N.J., June 25, 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 the submission to the U.S. Food and Drug Administration (FDA) of the Company’s New Drug Application (NDA) for GTx-104. The application includes a comprehensive data package, including positive data obtained from the Company’s Phase 3 STRIVE-ON safety trial of GTx-104, whereby it met its primary endpoint and provided evidence of clinical benefit when compared to orally administered nimodipine.
“The submission of our NDA for GTx-104 for the treatment of aSAH is a significant milestone for Grace Therapeutics, built on more than a decade of painstaking research and innovation,” said Prashant Kohli, Chief Executive Officer of Grace Therapeutics. “Our NDA is supported by a robust data package including positive results from our STRIVE-ON trial, which provide support for improved clinical outcomes in aSAH patients and both medical and pharmacoeconomic evidence of the potential benefit of GTx-104 in the treatment of aSAH. The standard of care for aSAH has not seen meaningful innovation in nearly 40 years, and we believe these results point to a very promising role for GTx-104 as a potential breakthrough for the care of aSAH patients. We look forward to engaging with the FDA during the review process.”
Submission of the NDA has the potential to trigger the exercise of up to
The FDA typically has a 60-day period to determine if the Company’s NDA is complete and acceptable for filing. Grace has obtained Orphan Drug Designation from the FDA for GTx-104, which generally provides seven years of marketing exclusivity in United States upon FDA approval of the NDA. Additionally, the Company believes that its U.S. and international patent estate will protect the market value of GTx-104 beyond marketing exclusivity.
About the STRIVE-ON Safety Trial
The STRIVE-ON safety trial (NCT05995405) was a prospective, randomized open-label trial of GTx-104 compared with oral nimodipine in patients hospitalized with aSAH. 50 patients were administered GTx-104 and 52 patients received oral nimodipine. The primary endpoint was the number of patients with at least one episode of clinically significant hypotension reasonably considered to be caused by the drug, and additional endpoints included safety, clinical, and pharmacoeconomic outcomes. The trial met its primary endpoint, with patients receiving GTx-104 observed to have a
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 IV 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 IV infusion.
GTx-104 provides a convenient IV 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 health 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 Therapeutic’s 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 IV 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.
Forward-Looking Statements
Statements in this press release that are not statements of historical or current fact constitute "forward-looking statements" within the meaning of the U.S. Private Securities Litigation Reform Act of 1995, as amended, Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, and "forward-looking information" within the meaning of Canadian securities laws (collectively, "forward-looking statements"). Such forward-looking statements involve known and unknown risks, uncertainties, and other factors that could cause the actual results of Grace Therapeutics to be materially different from historical results or from any future results expressed or implied by such forward-looking statements. In addition to statements which explicitly describe such risks and uncertainties, readers are urged to consider statements containing the terms "believes," "belief," "expects," "intends," "anticipates," "estimates," "potential," "should," "may," "will," "plans," "continue," "targeted" or other similar expressions to be uncertain and forward-looking. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. The forward-looking statements in this press release, including statements regarding, the future prospects of the Company’s GTx-104 drug candidate, the timing of the FDA’s acceptance for review of the Company’s NDA submission for GTx-104, benefits of GTx-104’s Orphan Drug Designation, GTx-104’s potential to bring enhanced treatment options to patients suffering from aSAH, GTx-104’s potential to be administered to improve the management of hypotension in patients with aSAH, the ability of GTx-104 to achieve a pharmacokinetic and safety profile similar to the oral form of nimodipine, GTx-104’s potential to achieve pharmacoeconomic benefit, higher dose compliance and better functional recovery over the oral form of nimodipine, GTx-104’s commercial prospects, and the Company’s patent estate and its ability to extend exclusivity of GTx-104 are based upon Grace Therapeutics’ current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, including, without limitation: (i) the success and timing of regulatory submissions of the Phase 3 STRIVE-ON safety trial for GTx-104; (ii) regulatory requirements or developments and the outcome and timing of the NDA application for GTx-104; (iii) changes to regulatory pathways; (iv) the Company’s ability to maintain effective patent rights and other intellectual property protection for its product candidates and (v) legislative, regulatory, political and economic developments. The foregoing list of important factors that could cause actual events to differ from expectations should not be construed as exhaustive and should be read in conjunction with statements that are included herein and elsewhere, including the risk factors detailed in the "Special Note Regarding Forward-Looking Statements," "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" sections of the Company's Annual Report on Form 10-K for the fiscal year ended March 31, 2025, and other documents that have been and will be filed by Grace Therapeutics from time to time with the Securities and Exchange Commission and Canadian securities regulators. All forward-looking statements contained in this press release speak only as of the date on which they were made. Grace Therapeutics undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by applicable securities laws.
For more information, please contact:
Grace Therapeutics Contact:
Prashant Kohli
Chief Executive Officer
Tel: 609-322-1602
Email: info@gracetx.com
www.gracetx.com
Investor Relations:
LifeSci Advisors
Mike Moyer
Managing Director
Phone: 617-308-4306
Email: mmoyer@lifesciadvisors.com
FAQ
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