Grace Therapeutics, Inc Stock Price, News & Analysis

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.

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.

Grace Therapeutics (NASDAQ:GRCE), a late-stage biopharma company, will present at the H.C. Wainwright 27th Annual Global Investment Conference from September 8-10, 2025. The conference will be held at the Lotte New York Palace Hotel with virtual participation options available.

The company's CEO, Prashant Kohli, will be available for one-on-one meetings with institutional investors. Grace Therapeutics is developing GTx-104, a novel injectable formulation of nimodipine for IV infusion, targeting unmet medical needs in aSAH patients.

Grace Therapeutics (NASDAQ:GRCE) announced that the FDA has accepted its New Drug Application (NDA) for GTx-104, a novel injectable formulation of nimodipine for treating aneurysmal Subarachnoid Hemorrhage (aSAH). The FDA has set a PDUFA target date of April 23, 2026 for review.

The NDA submission is supported by positive results from the Phase 3 STRIVE-ON safety trial. The acceptance triggers potential exercise of warrants worth $7.6 million at $3.003 per share, issued during a September 2023 private placement. GTx-104 has received Orphan Drug Designation, providing 7 years of marketing exclusivity upon approval.

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.

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 submission includes positive results from the Phase 3 STRIVE-ON safety trial, where GTx-104 met its primary endpoint and demonstrated clinical benefits compared to oral nimodipine.

The NDA submission could trigger up to $7.6 million in warrant exercises from the company's 2023 financing at $3.003 per share. Grace has secured Orphan Drug Designation for GTx-104, potentially providing 7 years of marketing exclusivity upon FDA approval. The FDA has a 60-day period to determine if the NDA is complete and acceptable for filing.