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    MeiraGTx Holdings plc filed SEC Form 8-K: Other Events, Financial Statements and Exhibits

    12/9/24 9:15:16 AM ET
    $MGTX
    Biotechnology: Biological Products (No Diagnostic Substances)
    Health Care
    Get the next $MGTX alert in real time by email
    0001735438false00017354382024-12-092024-12-09

    ​

    ​

    UNITED STATES

    SECURITIES AND EXCHANGE COMMISSION

    Washington, D.C. 20549

    FORM 8-K

    Current Report Pursuant to Section 13 or 15(d)

    of the Securities Exchange Act of 1934

    Date of Report (Date of earliest event reported): December 9, 2024

    MeiraGTx Holdings plc

    (Exact name of registrant as specified in its charter)

    ​

    ​

    ​

    ​

    ​

    ​

    Cayman Islands

        

    001-38520

        

    98-1448305

    (State or other jurisdiction of incorporation or
    organization)

     

    (Commission File Number)

     

    (I.R.S. Employer Identification No.)

    ​

    450 East 29th Street, 14th Floor

    New York, NY 10016

    (Address of principal executive offices) (Zip code)

    ​

    (646) 860-7985

    (Registrant’s telephone number, including area code)

    Not applicable

    (Former name or former address, if changed since last report)

    ​

    Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

    ​

    ☐ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

     

    ☐ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) 

     

    ☐ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) 

     

    ☐ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) 

    ​

    Securities registered pursuant to Section 12(b) of the Act:

    ​

    Title of each class

        

    Trading

    Symbol(s)

        

    Name of each exchange

    on which registered

    Ordinary Shares, $0.00003881 par
    value per share

     

    MGTX

     

    The Nasdaq Global Select Market

    ​

    Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

    ​

    Emerging growth company  ☐

    ​

    If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.  ☐

    ​

    ​

    ​

    ​

    ​

    Item 8.01

    Other Events.

    ​

    On December 9, 2024, MeiraGTx Holdings plc (the “Company”) issued a press release announcing that the U.S. Food and Drug Administration (FDA) has granted Regenerative Medicine Advanced Therapy (RMAT) designation to AAV2-hAQP1 for the treatment of Grade 2/3 radiation-induced xerostomia (RIX). A copy of the press release is filed as Exhibit 99.1 to this Current Report on Form 8-K (“Form 8-K”) and is incorporated herein by reference.

    ​

    Item 9.01.Financial Statements and Exhibits.

    ​

    (d)Exhibits.

    ​

    Exhibit No.

    Description

    99.1

    Press release of MeiraGTx Holdings plc, dated December 9, 2024.

    104

    Cover Page Interactive Data File (the cover page XBRL tags are embedded in the Inline XBRL document).

    ​

    ​

    ​

    2

    SIGNATURE

    Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

    ​

    ​

    ​

    Date: December 9, 2024

    ​

    ​

    ​

    ​

    MEIRAGTX HOLDINGS PLC

    ​

    ​

    ​

    ​

    ​

    By:

    /s/ Richard Giroux

    ​

    Name:

    Richard Giroux

    ​

    Title:

    Chief Financial Officer and Chief Operating Officer

    ​

    ​

    ​

    3

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