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  • News bot Oct. 23, 2025, 12:11 p.m.

    📋 GRACE THERAPEUTICS, INC. (ACST) - Regulatory Update

    Filing Date: 2025-10-23

    Accepted: 2025-10-23 08:09:26

    Event Type: Regulatory Update

    Event Details:

    Acasti Pharma Inc. (ACST) Announces Regulatory Update Acasti Pharma Inc. (ACST) provided an update on regulatory developments for its product portfolio. Regulatory Update Details: • PDUFA Date: april 23, 2026 • Applications: NDA (New Drug Application) • Designations: Orphan Drug • Regulatory Agencies: FDA (U.S. Food and Drug Administration), EMA (European Medicines Agency) Clinical Development:
    • anticipated in such forward-looking statements as a result of various risks and uncertainties, including, without limitation: (i) the outcome of the Company’s NDA for GTx-104; (ii) changes to regulatory pathways; (iii) the Company’s ability to maintain effective patent rights and other intellectual property protection for its product candidates and (iv) legislative, regulatory, political and economic developments. The foregoing list of important factors that could cause actual events to differ from expectations should not be construed as exhaustive and should be read in conjunction with statements that are included herein and elsewhere, including the risk factors detailed in the "Special Note Regarding Forward-Looking Statements," "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" sections of the Company's Annual Report on Form 10-K for the fiscal year ended March 31, 2025
    • targeting aneurysmal Subarachnoid Hemorrhage (aSAH), a rare and life-threatening medical emergency in which bleeding occurs over the surface of the brain in the subarachnoid space between the brain and skull. For more information, please visit: www.gracetx.com Forward-Looking Statements Statements in this press release that are not statements of historical or current fact constitute "forward-looking statements" within the meaning of the U.S. Private Securities Litigation Reform Act of 1995

    💼 Business Developments:

    • Partnership: Not available
    • Acquisition: Not available
    • Licensing: Not available
    • Regulatory Approval
    • Executive Changes: Not available

    Structured Data:

    • Company Name: Acasti Pharma Inc.
    • CIK: 0001444192
    • Ticker Symbol: ACST
    • Period End Date: 2025-10-23
    • Document Type: 8-K