Welcome to our dedicated page for Grace Therapeutics news (Ticker: GRCE), a resource for investors and traders seeking the latest updates and insights on Grace Therapeutics stock.
Grace Therapeutics, Inc. develops specialty biopharmaceutical products led by GTx-104, a clinical-stage injectable formulation of nimodipine for intravenous infusion in patients with aneurysmal subarachnoid hemorrhage, or aSAH. The company’s updates center on the GTx-104 New Drug Application, FDA correspondence, chemistry, manufacturing and controls matters, and clinical data from the STRIVE-ON Phase 3 safety trial.
Recurring news also covers medical-conference presentations, intellectual-property developments for nimodipine parenteral administration, quarterly financial results, corporate presentations, and capital actions such as warrant exercises tied to prior private placements.
Grace Therapeutics (Nasdaq: GRCE) announced the FDA issued a Complete Response Letter (CRL) on April 23, 2026 for the NDA for GTx-104, citing items in Chemistry, Manufacturing, and Controls (CMC) and Non-Clinical sections.
The FDA did not request additional clinical data. Cited issues include leachables data for packaging, non-clinical toxicology risk assessments, and manufacturing deficiencies at the contract manufacturer. The company intends to request a Type A meeting and resubmit after addressing the items.
Grace Therapeutics (Nasdaq: GRCE) announced that an abstract reporting results from its STRIVE-ON Phase 3 safety trial of GTX-104 (nimodipine IV) was accepted for presentation at the American Academy of Neurology annual meeting, April 18-22, 2026.
The STRIVE-ON results will appear as a poster on April 21, 2026 at 1:00 pm CT in Session S21: Neurocritical Care, titled "Safety and Tolerability of GTX-104 Compared with Oral Nimodipine".
Grace Therapeutics (Nasdaq: GRCE) announced that abstracts on the unmet needs and potential benefits of GTx-104 in aneurysmal subarachnoid hemorrhage (aSAH) were accepted for two March 2026 medical conferences.
The company will discuss Phase 3 STRIVE-ON trial data and present a poster on safety and tolerability versus oral nimodipine.
Grace Therapeutics (Nasdaq: GRCE) announced CEO Prashant Kohli will present at TD Cowen’s 46th Annual Health Care Conference in Boston on March 4, 2026 at 10:30 AM ET. An archived replay will be available for 90 days, and the CEO will also take part in investor meetings.
According to the company, Grace is advancing GTx-104, a clinical-stage injectable nimodipine formulation for IV infusion targeting aneurysmal subarachnoid hemorrhage patients.
Grace Therapeutics (Nasdaq: GRCE) reported Q3 FY2026 results and business updates focused on its NDA for GTx-104 in aneurysmal subarachnoid hemorrhage (aSAH). The FDA set a PDUFA target date of April 23, 2026. Q3 net loss was $2.3M versus $4.2M year-ago; cash was $18.7M at Dec 31, 2025, and potential warrant proceeds total $15.0M. The company completed the STRIVE-ON Phase 3 safety trial and presented results at a 2025 scientific meeting while continuing pre-commercial planning.
Grace Therapeutics (Nasdaq: GRCE) announced that CEO Prashant Kohli will present at the Craig-Hallum 16th Annual Alpha Select Conference on November 18, 2025 in New York.
Grace is a late-stage biopharma advancing GTx-104, an injectable nimodipine formulation for IV infusion to treat aneurysmal subarachnoid hemorrhage (aSAH) patients. The Alpha Select Conference is invitation-only; attending companies are selected for being smaller, underfollowed public companies with potential to scale. Investors seeking a meeting should contact their Craig-Hallum representative.
Grace Therapeutics (Nasdaq: GRCE) reported Q2 2026 results and business updates on Nov 13, 2025. Key corporate highlights: the FDA accepted the NDA for GTx-104 for review with a PDUFA target date of April 23, 2026; positive Phase 3 STRIVE-ON safety trial data were presented at the 2025 Neurocritical Care meeting; and a new U.S. patent covering the IV dosing regimen was issued, extending IP protection to 2043. The company also has orphan drug designation (seven years U.S. exclusivity if approved).
Q2 financials: net loss of $0.9M vs $3.4M year-ago; R&D $0.6M; cash ~$16.9M as of Sept 30, 2025 and about $20.0M as of Oct 31, 2025 after warrant exercises.
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) 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) presented results from its pivotal Phase 3 STRIVE-ON safety trial for GTx-104, a novel injectable formulation of nimodipine, at the 2025 Neurocritical Care Society annual meeting. The study compared GTx-104 to oral nimodipine in treating aneurysmal Subarachnoid Hemorrhage (aSAH).
The trial enrolled 102 patients (50 receiving GTx-104, 52 receiving oral nimodipine). Results showed GTx-104 demonstrated improved safety profile with reduced hypotensive events, shorter ICU stays, and decreased need for mechanical ventilation compared to oral nimodipine. The FDA is currently reviewing Grace's New Drug Application for GTx-104, with a PDUFA target date of April 23, 2026.