Company: GRCE
Filing Date: 2025-08-27
Form Type: 8-K
Source: 0001140361-25-032847
Chunk: 0

Company: Grace Therapeutics, Inc.
Filing Date: 2025-08-27
Form: 8-K
Item: Item 8.01
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Item 8.01.      Other Events.  

On August 27, 2025, Grace Therapeutics, Inc. (the “ Company”) issued a press release announcing that, on August 22, 2025, the U. S.
Food and Drug Administration (“ FDA”) accepted the Company’s New Drug Application (“ NDA”) for GTx-104 for formal review. GTx-104 is a clinical-stage, novel, injectable formulation of nimodipine being developed for IV infusion to address
significant unmet medical needs in aneurysmal subarachnoid hemorrhage patients. The FDA established a Prescription Drug User Fee Act (PDUFA) target date of April 23, 2026 for its review of the Company’s NDA submission.

A copy of the press release is attached hereto as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated by reference
into this Item 8.01.

  Item 9.01.      Financial Statements and Exhibits.