Grace Therapeutics Announces Alignment with the FDA Supporting the Planned NDA Submission for GTx-104
Grace Therapeutics (NASDAQ: GRCE) has announced positive alignment with the FDA regarding their planned New Drug Application (NDA) submission for GTx-104, a novel injectable formulation of nimodipine for treating aneurysmal subarachnoid hemorrhage (aSAH) patients.
Following a Type C meeting with the FDA, the company confirmed that their current data and regulatory packages should be sufficient for NDA submission, anticipated in Q2 2025. The STRIVE-ON safety trial demonstrated that GTx-104, administered via IV infusion, showed:
- Fewer patients with clinically significant hypotension
- Higher dose compliance
- Better functional recovery
- Lower pharmacoeconomic burden
This development represents the first potential innovation in aSAH treatment in almost four decades, addressing significant unmet medical needs caused by limitations of enteral administration.
Grace Therapeutics (NASDAQ: GRCE) ha annunciato un allineamento positivo con la FDA riguardo alla loro pianificata presentazione della Nuova Richiesta di Medicinali (NDA) per GTx-104, una nuova formulazione iniettabile di nimodipina per il trattamento dei pazienti con emorragia subaracnoidea aneurismatica (aSAH).
Dopo un incontro di Tipo C con la FDA, l'azienda ha confermato che i dati attuali e i pacchetti normativi dovrebbero essere sufficienti per la presentazione dell'NDA, prevista per il secondo trimestre del 2025. Il trial di sicurezza STRIVE-ON ha dimostrato che GTx-104, somministrato tramite infusione endovenosa, ha mostrato:
- Un numero inferiore di pazienti con ipotensione clinicamente significativa
- Maggiore aderenza al dosaggio
- Un migliore recupero funzionale
- Un minore onere farmacoeconomico
Questo sviluppo rappresenta la prima potenziale innovazione nel trattamento dell'aSAH in quasi quattro decenni, affrontando significative esigenze mediche non soddisfatte causate dalle limitazioni della somministrazione enterale.
Grace Therapeutics (NASDAQ: GRCE) ha anunciado una alineación positiva con la FDA respecto a su planificada presentación de la Nueva Solicitud de Medicamento (NDA) para GTx-104, una nueva formulación inyectable de nimodipina para tratar a pacientes con hemorragia subaracnoidea aneurismática (aSAH).
Después de una reunión de Tipo C con la FDA, la compañía confirmó que sus datos actuales y paquetes regulatorios deberían ser suficientes para la presentación de la NDA, anticipada para el segundo trimestre de 2025. El ensayo de seguridad STRIVE-ON demostró que GTx-104, administrado por infusión intravenosa, mostró:
- Menos pacientes con hipotensión clínicamente significativa
- Mayor cumplimiento de dosis
- Mejor recuperación funcional
- Menor carga farmacoeconómica
Este desarrollo representa la primera potencial innovación en el tratamiento de aSAH en casi cuatro décadas, abordando necesidades médicas significativas no satisfechas causadas por las limitaciones de la administración enteral.
Grace Therapeutics (NASDAQ: GRCE)는 뇌동맥류 지주막하 출혈(aSAH) 환자를 치료하기 위한 새로운 주사 제형인 GTx-104의 새로운 약물 신청(NDA) 제출에 대해 FDA와 긍정적인 조율을 발표했습니다.
FDA와의 C형 미팅 후, 회사는 현재의 데이터와 규제 패키지가 NDA 제출에 충분할 것이라고 확인했으며, 이는 2025년 2분기로 예상됩니다. STRIVE-ON 안전성 시험은 IV 주사를 통해 투여된 GTx-104가 다음과 같은 결과를 보였다고 밝혔습니다:
- 임상적으로 중요한 저혈압을 앓고 있는 환자 수 감소
- 더 높은 복용 준수율
- 더 나은 기능적 회복
- 더 낮은 약제 경제적 부담
이 개발은 거의 40년 만에 aSAH 치료에 있어 첫 번째 잠재적 혁신을 나타내며, 경구 투여의 한계로 인한 중요한 의료적 요구를 해결합니다.
Grace Therapeutics (NASDAQ: GRCE) a annoncé un alignement positif avec la FDA concernant leur demande de nouveau médicament (NDA) prévue pour GTx-104, une nouvelle formulation injectable de nimodipine pour le traitement des patients souffrant d'hémorragie subarachnoïdienne aneurysmale (aSAH).
À la suite d'une réunion de type C avec la FDA, la société a confirmé que ses données actuelles et ses dossiers réglementaires devraient être suffisants pour la soumission de la NDA, prévue pour le deuxième trimestre 2025. L'
- Moins de patients avec une hypotension cliniquement significative
- Une meilleure adhésion au dosage
- Une meilleure récupération fonctionnelle
- Un fardeau pharmacoeconomique réduit
Ce développement représente la première innovation potentielle dans le traitement de l'aSAH depuis près de quatre décennies, répondant à des besoins médicaux non satisfaits importants causés par les limitations de l'administration entérale.
Grace Therapeutics (NASDAQ: GRCE) hat eine positive Abstimmung mit der FDA bezüglich ihrer geplanten Einreichung eines Neuen Arzneimittelantrags (NDA) für GTx-104, eine neuartige injizierbare Formulierung von Nimodipin zur Behandlung von Patienten mit aneurysmatischer Subarachnoidalblutung (aSAH), bekannt gegeben.
Nach einem Typ-C-Meeting mit der FDA bestätigte das Unternehmen, dass ihre aktuellen Daten und regulatorischen Pakete für die NDA-Einreichung ausreichend sein sollten, die für das 2. Quartal 2025 erwartet wird. Die STRIVE-ON Sicherheitsstudie zeigte, dass GTx-104, das über eine IV-Infusion verabreicht wurde, folgende Ergebnisse zeigte:
- Weniger Patienten mit klinisch signifikantem Hypotonie
- Höhere Dosierungsadhärenz
- Bessere funktionelle Erholung
- Niedrigere pharmakoökonomische Belastung
Diese Entwicklung stellt die erste potenzielle Innovation in der aSAH-Behandlung seit fast vier Jahrzehnten dar und adressiert bedeutende ungedeckte medizinische Bedürfnisse, die durch die Einschränkungen der enteralen Verabreichung verursacht werden.
- FDA alignment supports planned NDA submission pathway
- STRIVE-ON trial demonstrated superior clinical outcomes
- First potential innovation in aSAH treatment in 40 years
- Product addresses significant unmet medical needs
- NDA submission still subject to FDA's complete review and acceptance
- Final approval timeline uncertain
Insights
This FDA feedback represents a significant regulatory milestone for Grace Therapeutics. The positive outcome from their Type C meeting substantially de-risks the regulatory pathway for GTx-104. Achieving FDA alignment on the NDA submission requirements - including clinical, non-clinical, and CMC components - removes a major hurdle in the development process.
For context, Type C meetings typically address specific questions about development programs, and positive feedback at this stage suggests the FDA sees merit in the data package. The agency's receptiveness to the completed Phase 3 STRIVE-ON safety trial data is particularly noteworthy, as safety concerns often derail late-stage candidates.
The Q2 2025 NDA submission timeline provides a clear near-term catalyst. For a company with merely a
The 40-year innovation gap in aSAH treatment that GTx-104 aims to address further strengthens the regulatory case, as the FDA typically prioritizes areas of significant unmet need. This positions Grace favorably for their upcoming submission.
The clinical rationale for GTx-104 addresses a fundamental problem in aSAH management. The current standard treatment with oral nimodipine faces significant challenges due to the pathophysiology of subarachnoid hemorrhage and nimodipine's pharmacokinetic profile.
aSAH patients frequently experience impaired consciousness, swallowing difficulties, and gastrointestinal complications - all of which compromise enteral medication administration. The STRIVE-ON trial results suggesting fewer episodes of clinically significant hypotension is particularly important, as hypotensive episodes can exacerbate cerebral ischemia in these vulnerable patients.
The improved dose compliance noted in the trial addresses another critical issue - the current standard of care requires dosing every 4 hours, which is difficult to maintain and often leads to suboptimal blood levels. An IV formulation enabling consistent therapeutic levels would represent a meaningful advancement.
Better functional recovery outcomes, if substantiated in the final data, would translate to meaningful quality-of-life improvements for patients who often face devastating neurological deficits following aSAH. The lower pharmacoeconomic burden suggests potential healthcare system benefits through reduced complications and possibly shorter ICU stays.
This advancement could meaningfully improve care for the approximately 30,000 Americans who suffer aSAH annually - a condition with high mortality and morbidity rates.
NDA Submission Anticipated Q2 Calendar 2025
PRINCETON, N.J., April 09, 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 details of the Company’s Type C meeting with the U.S. Food and Drug Administration (FDA). The purpose of this meeting was to obtain FDA feedback on the completed Phase 3 STRIVE-ON safety trial of GTx-104 and its planned New Drug Application (NDA) submission including clinical, non-clinical, and chemistry, manufacturing, and control (CMC) requirements.
Based on feedback from the FDA, the Company believes that the data and regulatory packages as currently structured will be sufficient for submission of an NDA.
“Our recent interactions with the FDA have been positive and productive, and we are pleased to achieve alignment with the agency on the substance and structure of our NDA submission,” said Prashant Kohli, Chief Executive Officer of Grace Therapeutics. “Due to a unique combination of nimodipine pharmacokinetic characteristics and debilitating aSAH pathophysiology, the enteral route of administration results in significant unmet medical needs in the treatment of aSAH, presenting a compelling clinical rationale for GTx-104 to be administered as an IV infusion of nimodipine. As evidenced from our STRIVE-ON trial data, GTx-104 had fewer patients with clinically significant hypotension, more patients with higher dose compliance and better functional recovery, and lower pharmacoeconomic burden. We are excited about the prospects of GTx-104 to help improve patient outcomes upon potential FDA approval, and to deliver the first innovation for the treatment of aSAH in almost four decades.”
The Company anticipates filing its NDA for GTx-104 in the second quarter of 2025. Acceptance of the NDA will be subject to the FDA’s review of the complete filing.
About the STRIVE-ON Trial
The STRIVE-ON 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 100 patients 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 Company’s anticipated NDA submission for GTx-104, 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 any future patent and other intellectual property filings made by the Company for new developments 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 proposed NDA application for GTx-104; (iii) changes to regulatory pathways; and (iv) 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, 2024, Quarterly Report on Form 10-Q for the quarterly period ended June 30, 2024, the Quarterly Report on Form 10-Q for the quarterly period ended September 30, 2024, the Quarterly Report on Form 10-Q for the quarterly period ended December 31, 2024, as amended by Amendment No. 1 on Form 10-Q/A, 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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