#GRCE Grace Therapeutics Announces Second Quarter 2026 Financial Results, Provides Business Update

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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.

#GRCE Grace Therapeutics Announces Abstract Accepted for Presentation at Society of Vascular and Interventional Neurology Annual Meeting

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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, 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

#GRCE Grace Therapeutics Secures Approximately $4.0 Million through Common Warrant Exercises Following Acceptance of New Drug Application for GTx-104 for formal FDA Review

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Breakthrough in Brain Hemorrhage Treatment: Grace's GTx-104 Shows Superior Safety Profile in Critical Phase 3 Trial Grace Therapeutics' GTx-104 demonstrates improved safety profile vs. oral nimodipine in 102-patient aSAH trial. Reduces ICU stays, ventilation needs. FDA decision expected April 2026.

#GRCE Grace Therapeutics Pivotal Phase 3 STRIVE-ON Safety Trial Presented at 2025 Neurocritical Care Annual Meeting

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Grace Therapeutics Granted Sixth U.S. Patent Covering I.V. Dosing Regimen for GTx-104 Grace Therapeutics (NASDAQ:GRCE) has secured its sixth U.S. patent (No. 12,414,943) for GTx-104, covering the I.V. dosing regimen of its novel injectable nimodipine formulation. This new method of use patent extends the company's patent protection until 2043, complementing its existing five patents on composition that provide protection until 2037.GTx-104 is being developed to address unmet needs in aSAH (aneurysmal subarachnoid hemorrhage) patients. The drug has received FDA Orphan Drug Designation, which will provide seven years of marketing exclusivity upon NDA approval. The patent specifically covers the dosing regimen used in the Phase 3 STRIVE-ON safety trial.

#GRCE Grace Therapeutics Granted Sixth U.S. Patent Covering I.V. Dosing Regimen for GTx-104

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Late-Stage Biopharma Grace Therapeutics Showcasing Novel aSAH Treatment at Major Investment Conference Grace Therapeutics CEO Prashant Kohli to present on GTx-104, a novel injectable nimodipine formulation for aSAH patients, at H.C. Wainwright Conference in NYC Sept 8-10, 2025.

#GRCE Grace Therapeutics Announces Presentation at The H.C. Wainwright 27th Annual Global Investment Conference

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Breakthrough aSAH Treatment: Grace Therapeutics' GTx-104 NDA Accepted by FDA After 40 Years Without Innovation FDA accepts Grace Therapeutics' NDA for GTx-104 in aneurysmal Subarachnoid Hemorrhage with PDUFA date set for April 23, 2026. Includes Orphan Drug status and $7.6M warrant potential.

#GRCE Grace Therapeutics Announces U.S. Food and Drug Administration Acceptance for Review of New Drug Application for GTx-104

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#GRCE: Looking Ahead to Acceptance buff.ly/i4DONFT

Grace Therapeutics Announces First Quarter 2026 Financial Results, Provides Business Update 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 NDA is supported by successful Phase 3 STRIVE-ON safety trial results, which met its primary endpoint and demonstrated clinical benefits compared to oral nimodipine.For Q1 2026, Grace reported a net loss of $3.4 million ($0.21 per share), compared to $2.6 million loss in Q1 2025. The company's cash position stands at $20.0 million, with potential additional proceeds of $22.6 million from warrant exercises. The company has secured Orphan Drug Designation for GTx-104, providing 7 years of marketing exclusivity upon FDA approval.

#GRCE Grace Therapeutics Announces First Quarter 2026 Financial Results, Provides Business Update

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Senior Equity Analyst @vanjohn10.bsky.social highlights four companies' new product applications with the FDA: youtu.be/Ha0u0n87afc?...

#ACHV #GRCE #CING #MDAI

#GRCE: NDA Submitted buff.ly/dbsuh3m

First Innovation in 40 Years: Grace Therapeutics Submits Breakthrough aSAH Drug to FDA Novel injectable nimodipine formulation GTx-104 targets rare brain hemorrhage condition. FDA acceptance could trigger $7.6M in warrant proceeds. See trial results.

#GRCE Grace Therapeutics Announces Submission of New Drug Application to U.S. Food and Drug Administration for GTx-104

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Grace Therapeutics Announces 2025 Fiscal Year-End Results, Provides Business Update Grace Therapeutics (NASDAQ: GRCE) reported fiscal year 2025 results and significant progress in developing GTx-104, a novel injectable nimodipine formulation for aneurysmal subarachnoid hemorrhage (aSAH). The company successfully completed its Phase 3 STRIVE-ON safety trial, meeting primary endpoints and showing improved clinical outcomes compared to oral nimodipine. Grace secured $15M in upfront financing through a private placement, with potential for additional $15M through warrant exercises. The company plans to submit its New Drug Application (NDA) by June 2025 following positive FDA feedback. Financial results showed a reduced net loss of $9.6M ($0.79 per share) compared to $12.9M in FY2024. Cash position stands at $22.1M, providing runway into Q3 2026, potentially extending to Q2 2027 if all warrants are exercised.

#GRCE Grace Therapeutics Announces 2025 Fiscal Year-End Results, Provides Business Update

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#GRCE Grace Therapeutics, Inc. will soon submit its new drug application (NDA) to the FDA

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#GRCE: Progress Report buff.ly/EXlTAyU

Breakthrough aSAH Treatment Gets FDA Green Light for NDA: Grace's GTx-104 Shows Superior Outcomes Novel injectable nimodipine demonstrates superior clinical outcomes in STRIVE-ON trial. First potential innovation for aneurysmal subarachnoid hemorrhage in 40 years.

#GRCE Grace Therapeutics Announces Alignment with the FDA Supporting the Planned NDA Submission for GTx-104

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#GRCE: STRIVE-ON Results Reported buff.ly/4hOi4sv

Grace Reports Clinical Trial Victory and Major Cash Infusion in Latest Earnings Grace's Q3 features successful Phase 3 STRIVE-ON trial results and $15M financing, despite wider losses. NDA submission for GTx-104 planned for June 2025.

#GRCE Grace Therapeutics Announces Third Fiscal Quarter 2025 Financial Results, Provides Business Update

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Grace Therapeutics Lands Strategic $30M Financing Deal: Major Boost for Critical Brain Hemorrhage Treatment Grace Therapeutics raises $15M upfront with potential $30M total funding, backed by healthcare investors for GTx-104 development in brain hemorrhage treatment.

#GRCE Grace Therapeutics Announces Private Placement Financing of up to $30 Million

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Grace Therapeutics Announces Results From Pivotal Phase 3 STRIVE-ON Safety Trial of GTx-104 in aSAH Grace Therapeutics (NASDAQ: GRCE) announced positive results from its Phase 3 STRIVE-ON safety trial for GTx-104, an injectable formulation of nimodipine for aneurysmal Subarachnoid Hemorrhage (aSAH) patients. The trial, involving 102 patients, met its primary endpoint with a 19% reduction in clinically significant hypotension compared to oral nimodipine (28% vs 35%).Key findings include: 54% of GTx-104 patients achieved ≥95% relative dose intensity versus 8% for oral nimodipine; a 29% relative increase in favorable outcomes at 90 days; improved quality of life measures; and fewer ICU readmissions and ventilator days. While safety profiles were comparable, there were eight deaths in the GTx-104 arm versus four in the oral nimodipine arm, all attributed to disease severity.The company plans to submit a New Drug Application (NDA) in the first half of 2025.

#GRCE Grace Therapeutics Announces Results From Pivotal Phase 3 STRIVE-ON Safety Trial of GTx-104 in aSAH

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BREAKING NEWS: ( NASDAQ: #GRCE ) Grace Therapeutics to Exhibit at the American Society of Health-System Pharmacists Conference

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Grace Therapeutics to Showcase Novel aSAH Treatment at Major ASHP Clinical Meeting Ahead of Phase 3 Data | GRCE Stock News Grace Therapeutics advances GTx-104, its innovative injectable nimodipine treatment for brain hemorrhage, presenting to 60,000+ healthcare professionals at ASHP conference.

#GRCE Grace Therapeutics to Exhibit at the American Society of Health-System Pharmacists Conference

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