- Grace Therapeutics, Inc. announced that the U.S. Patent and Trademark Office issued **U.S. Patent No. 12,414,943**, titled "Nimodipine Parenteral Administration".  **[1444192_0001140361-25-035337_ef20055717_ex99-1.htm:0]** **[1444192_0001140361-25-035337_ef20055717_8k.htm:1]** 
- 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.  **[1444192_0001140361-25-035337_ef20055717_ex99-1.htm:0]** **[1444192_0001140361-25-035337_ef20055717_8k.htm:1]** **[1444192_0001140361-25-035337_ef20055717_ex99-1.htm:1]** 
- The new method of use patent, published on **September 16, 2025**, **extends intellectual property protection for GTx-104 to 2043**.  **[1444192_0001140361-25-035337_ef20055717_ex99-1.htm:0]** **[1444192_0001140361-25-035337_ef20055717_8k.htm:1]** 
- GTx-104 also has **Orphan Drug Designation** from the FDA, which provides **seven years of marketing exclusivity** in the United States upon FDA approval.  **[1444192_0001140361-25-035337_ef20055717_ex99-1.htm:0]** **[1444192_0001140361-25-035337_ef20055717_ex99-1.htm:1]**

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

- 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).  **[1444192_2145862_1]** **[1444192_2145862_4]** 
- The FDA has **accepted the NDA** for GTX-104, assigning a PDUFA goal date of **April 23, 2026**.  **[1444192_2145862_4]** 
- 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.  **[1444192_2145862_4]** **[1444192_2145862_5]** 
- 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.  **[1444192_2145862_1]** **[1444192_2145862_5]**

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

- 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.  **[1444192_0001140361-25-032847_ef20054617_ex99-1.htm:0]** **[1444192_0001140361-25-032847_ef20054617_8k.htm:1]** 
- 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**.  **[1444192_0001140361-25-032847_ef20054617_ex99-1.htm:0]** 
- The **FDA established a Prescription Drug User Fee Act (PDUFA) target date of April 23, 2026** for the review of the NDA.  **[1444192_0001140361-25-032847_ef20054617_ex99-1.htm:0]** **[1444192_0001140361-25-032847_ef20054617_8k.htm:1]** 
- 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**.  **[1444192_0001140361-25-032847_ef20054617_ex99-1.htm:0]** 
- **GTx-104** has **Orphan Drug Designation** from the FDA, which generally provides **seven years of marketing exclusivity** in the U.S. upon approval.  **[1444192_0001140361-25-032847_ef20054617_ex99-1.htm:0]** **[1444192_0001140361-25-032847_ef20054617_ex99-1.htm:2]**

Grace Therapeutics (GRCE)