- 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)