Grace Therapeutics: FDA To Review NDA For GTx-104

(RTTNews) - Grace Therapeutics (GRCE) announced that on August 22, 2025 the FDA accepted the New Drug Application for GTx-104 for formal review. The application seeks approval for GTx-104 for the treatment of patients with aSAH. The FDA established a PDUFA target date of April 23, 2026 for its review of the NDA submission.

Grace Therapeutics noted that the acceptance of the NDA for review triggers the potential exercise of up to $7.6 million in warrants issued as part of a private placement the company completed in September 2023.

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