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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) received formal Type A meeting minutes from the U.S. FDA regarding the Complete Response Letter (CRL) issued on April 23, 2026 for GTx-104, its IV nimodipine candidate for aneurysmal subarachnoid hemorrhage (aSAH).
The FDA did not identify any clinical safety or efficacy deficiencies for GTx-104 and did not request additional clinical data. Outstanding CRL items focus on cGMP compliance at the current contract manufacturing organization, plus additional leachables data time points and excipient toxicology risk assessments, which the company plans to address with required non-clinical studies.
Grace Therapeutics is advancing a dual-source manufacturing strategy, maintaining its existing manufacturer while transferring technology to a second U.S.-based site to support NDA resubmission. GTx-104’s STRIVE-ON trial met its primary endpoint, showing lower clinically significant hypotension versus oral nimodipine, and has Orphan Drug Designation with potential U.S. market exclusivity.
Grace Therapeutics (Nasdaq: GRCE) reported fiscal 2026 results and regulatory updates for GTx-104 for aSAH.
The FDA issued an April 2026 Complete Response Letter citing CMC, non-clinical and cGMP items, with no clinical deficiencies. A Type A meeting is scheduled. Net loss was $7.8M versus $9.6M in 2025; R&D fell to $2.4M and G&A rose to $8.7M. Cash was $17.0M, and the company believes this funds operations for at least 12 months. Phase 3 STRIVE-ON data were presented at multiple conferences, and new U.S. patent protection extends potential GTx-104 coverage to 2043 alongside Orphan Drug Designation.
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.