Grace Therapeutics Secures Approximately $4.0 Million through Common Warrant Exercises Following Acceptance of New Drug Application for GTx-104 for formal FDA Review
Grace Therapeutics (Nasdaq: GRCE) announced it secured approximately $4.0 million through exercises of common warrants following FDA acceptance of the New Drug Application (NDA) for GTx-104.
The company issued 1,345,464 new shares at an exercise price of $3.003 per share. 1,190,927 remaining common warrants from the 2023 private placement expired after the 60th day following FDA acceptance.
The FDA set a PDUFA target date of April 23, 2026 for review of the NDA for GTx-104, an IV nimodipine formulation for aneurysmal subarachnoid hemorrhage, supported by positive Phase 3 STRIVE-ON safety data.
Grace Therapeutics (Nasdaq: GRCE) ha annunciato di aver ottenuto circa 4,0 milioni di dollari attraverso l'esercizio di warrant comuni dopo l'accettazione da parte della FDA della New Drug Application (NDA) per GTx-104.
La società ha emesso 1.345.464 nuove azioni a un prezzo di esercizio di 3,003 dollari per azione. 1.190.927 warrant comuni rimanenti dalla collocazione privata del 2023 sono scaduti dopo i 60 giorni successivi all'accettazione da parte della FDA.
La FDA ha fissato una data obiettivo PDUFA del 23 aprile 2026 per la revisione della NDA di GTx-104, una formulazione endovenosa di nimodipina per l'emorragia subaracnoidea aneurismale, supportata dai dati di sicurezza positivi dello studio di fase 3 STRIVE-ON.
Grace Therapeutics (Nasdaq: GRCE) anunció que obtuvo aproximadamente 4,0 millones de dólares mediante ejercicios de warrants ordinarios tras la aceptación por la FDA de la New Drug Application (NDA) para GTx-104.
La empresa emitió 1.345.464 nuevas acciones a un precio de ejercicio de 3,003 dólares por acción. 1.190.927 warrants ordinarios restantes de la colocación privada de 2023 expiraron después de los 60 días siguientes a la aceptación por la FDA.
La FDA fijó una fecha objetivo PDUFA del 23 de abril de 2026 para la revisión de la NDA de GTx-104, una formulación intravenosa de nimodipina para la hemorragia subaracnoidea aneurismal, respaldada por datos de seguridad positivos del estudio STRIVE-ON de fase 3.
Grace Therapeutics (나스닥: GRCE)는 FDA가 GTx-104의 신약승인신청(NDA)을 수용한 후 일반 워런트의 행사로 약 4,000,000달러를 확보했다고 발표했습니다.
회사는 주당 행사가 3.003달러의 조건으로 1,345,464주의 신규 주식을 발행했습니다. 2023년 비공개 배치에서 남은 일반 워런트 1,190,927주는 FDA 수용 이후 60일이 경과한 후 만료되었습니다.
FDA는 GTx-104의 NDA 심사를 위한 PDUFA 목표일을 2026년 4월 23일로 설정했으며, 이는 동맥류성 지주하강출혈에 대한 정맥nimodipine 제형으로, 3상 STRIVE-ON의 안전성 데이터가 뒷받침합니다.
Grace Therapeutics (Nasdaq : GRCE) a annoncé avoir sécurisé environ 4,0 millions de dollars grâce à l'exercice d'options d'actions ordinaires après l'acceptation par la FDA de la New Drug Application (NDA) pour GTx-104.
La société a émis 1 345 464 nouvelles actions à un prix d'exercice de 3,003 dollars par action. 1 190 927 warrants ordinaires restants de la levée privée de 2023 ont expiré après les 60 jours suivant l'acceptation par la FDA.
La FDA a fixé une date cible PDUFA du 23 avril 2026 pour l'examen de la NDA de GTx-104, une formulation intraveineuse de nimodipine pour l'hémorragie sous-arachnoïdienne d'origine annéurysmal, soutenue par les données de sécurité positives de l'étude STRIVE-ON de phase 3.
Grace Therapeutics (Nasdaq: GRCE) gab bekannt, dass es etwa 4,0 Millionen USD durch Ausübung von Stammwarrants nach der Aufnahme der New Drug Application (NDA) für GTx-104 durch die FDA beschafft hat.
Das Unternehmen gab 1.345.464 neue Aktien zu einem Ausübungspreis von 3,003 USD pro Aktie aus. 1.190.927 verbleibende Stammwarrants aus der privaten Platzierung 2023 liefen nach 60 Tagen nach der FDA-Annahme aus.
Die FDA setzte ein PDUFA-Zieldatum auf den 23. April 2026 für die Überprüfung der NDA von GTx-104, einer intravenösen Nimodipin-Formulierung für aneurysmal subarachnoid hemorrhage, unterstützt durch positive Sicherheitsdaten der Phase-3-STRIVE-ON-Studie.
Grace Therapeutics (نَسْدَاك: GRCE) أعلنت أنها نجحت في جمع نحو 4.0 مليون دولار من خلال ممارسة خيارات warrants العادية عقب قبول FDA لطلب الدواء الجديد (NDA) لـ GTx-104.
أصدرت الشركة 1,345,464 سهمًا جديدًا بسعر تنفيذ قدره 3.003 دولارًا للسهم. وتبقى من warrants العادية من الإصدار الخاص لعام 2023 1,190,927 وقد انتهت صلاحيتها بعد مرور 60 يومًا من قبول FDA.
حددت FDA تاريخ هدف PDUFA لــ 23 أبريل 2026 لمراجعة NDA لـ GTx-104، وهو صيغة nimodipine الوريدية لعلاج نزف تحت العنكبوتية الناتج عن أم الدم، ويدعمه بيانات أمان إيجابية من تجربة STRIVE-ON للمرحلة 3.
Grace Therapeutics（纳斯达克：GRCE）宣布在 FDA 接受 GTx-104 的新药申请（NDA）后，通过行使普通认股权证筹集了大约 400万美元资金。
公司以每股 3.003 美元 的行使价发行了 1,345,464 股新股。2023 年私募发行中剩余的普通认股权证 1,190,927 在 FDA 接受后60天后到期。
FDA 为 GTx-104 的 NDA 审评设定了 PDUFA 目标日，为 2026 年 4 月 23 日，这是用于动脉瘤性蛛网膜下腔出血的静脉 nimodipine 制剂的审评，得到三期 STRIVE-ON 安全性数据的支持。
- $4.0M secured through warrant exercises
- FDA set PDUFA date of April 23, 2026 for GTx-104 review
- NDA supported by positive Phase 3 STRIVE-ON safety data
- Issued 1,345,464 new shares at $3.003 increasing shares outstanding
- 1,190,927 common warrants expired, reducing potential future cash inflows
PRINCETON, N.J., Oct. 23, 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 I.V. infusion to address significant unmet medical needs in aneurysmal subarachnoid hemorrhage (aSAH) patients, today announced it has secured approximately
The FDA established a Prescription Drug User Fee Act (PDUFA) target date of April 23, 2026 for its review of the Company’s NDA submission for GTx-104. The application seeks approval for GTx-104 for the treatment of patients with aSAH, and is supported by a comprehensive data package including positive data obtained from the Company’s Phase 3 STRIVE-ON safety trial of GTx-104.
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 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 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
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 and the outcome of the FDA’s 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, 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 outcome of the Company’s NDA for GTx-104; (ii) changes to regulatory pathways; (iii) the Company’s ability to maintain effective patent rights and other intellectual property protection for its product candidates 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, 2025, the Company’s Quarterly Report on Form 10-Q for the quarterly period ended June 30, 2025 filed with the Securities and Exchange Commission (SEC) and other documents that have been and will be filed by Grace Therapeutics from time to time with the SEC 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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