Grace Therapeutics (GRCE) Company Report

Grace Therapeutics reported a net loss of $0.9 million (or $0.06 per share) for the second quarter of 2026 (three months ended September 30, 2025), a decrease from a net loss of $3.4 million (or $0.30 per share) for the same period in the prior year.
The FDA accepted the New Drug Application (NDA) for GTx-104 for formal review on August 22, 2025, establishing April 23, 2026, as the PDUFA target date.
The company's cash and cash equivalents were $16.9 million as of September 30, 2025, and an estimated $20.0 million as of October 31, 2025, with a projected cash runway through at least the next twelve months, potentially extending into Q2 2027.
A new U.S. patent covering the IV dosing regimen for GTx-104 was issued on September 16, 2025, extending intellectual property protection to 2043.

Nov 13, 2025, 1:01 PM

Grace Therapeutics Granted Sixth U.S. Patent for GTx-104

GRCE

New Projects/Investments

Grace Therapeutics, Inc. announced that the U.S. Patent and Trademark Office issued U.S. Patent No. 12,414,943, titled "Nimodipine Parenteral Administration".
This sixth U.S. patent covers the I.V. dosing regimen for GTx-104, a novel injectable formulation of nimodipine being developed for aneurysmal subarachnoid hemorrhage (aSAH) patients.
The new method of use patent, published on September 16, 2025, extends intellectual property protection for GTx-104 to 2043.
GTx-104 also has Orphan Drug Designation from the FDA, which provides seven years of marketing exclusivity in the United States upon FDA approval.

Sep 18, 2025, 12:43 PM

Grace Therapeutics' GTX-104 NDA Accepted by FDA, PDUFA Set for April 2026

GRCE

New Projects/Investments

Guidance Update

Grace Therapeutics reported strong positive data in February of this year from its pivotal Phase 3 STRY1 trial for GTX-104, an IV formulation of amlodipine targeting subarachnoid hemorrhage (SAH).
The FDA has accepted the NDA for GTX-104, assigning a PDUFA goal date of April 23, 2026.
The trial demonstrated improved clinical outcomes (e.g., 20% fewer hypotensive events, 30% good recovery) and significant pharmaco-economic benefits (e.g., reduced ICU length of stay) for GTX-104 compared to oral amlodipine.
GTX-104 benefits from robust patent protection, including orphan drug exclusivity and patents extending to 2042, and the company has $20 million in cash (as of end of June) with potential warrant proceeds of $23 million to fund operations into 2027.

Sep 16, 2025, 7:30 PM

Grace Therapeutics Announces FDA Acceptance of GTx-104 NDA

GRCE

Product Launch

New Projects/Investments

Grace Therapeutics announced on August 27, 2025, that the U.S. Food and Drug Administration (FDA) accepted its New Drug Application (NDA) for GTx-104 for formal review.
The NDA seeks approval for GTx-104 to treat patients with aneurysmal Subarachnoid Hemorrhage (aSAH), supported by positive data from the Phase 3 STRIVE-ON safety trial.
The FDA established a Prescription Drug User Fee Act (PDUFA) target date of April 23, 2026 for the review of the NDA.
The acceptance of the NDA triggers the potential exercise of up to $7.6 million in warrants from a September 2023 private placement, exercisable at $3.003 per share.
GTx-104 has Orphan Drug Designation from the FDA, which generally provides seven years of marketing exclusivity in the U.S. upon approval.