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    MetaVia Inc. filed SEC Form 8-K: Regulation FD Disclosure, Other Events, Financial Statements and Exhibits

    7/9/26 8:35:31 AM ET
    $MTVA
    Biotechnology: Pharmaceutical Preparations
    Health Care
    Get the next $MTVA alert in real time by email
    false 0001638287 METAVIA INC. 0001638287 2026-07-09 2026-07-09 iso4217:USD xbrli:shares iso4217:USD xbrli:shares

     

     

     

    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): July 9, 2026

     

     

    Metavia inc.

    (Exact name of Registrant as Specified in Its Charter)

     

    Delaware 001-37809 47-2389984
    (State or other jurisdiction
    of incorporation)
    (Commission
    File Number)
    (IRS Employer
    Identification No.)
         

    545 Concord Avenue, Suite 210

    Cambridge, Massachusetts

    (Address of principal executive offices)

      02138
    (Zip Code)

     

    (857) 702-9600

    (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

    Common Stock, par value $0.001 per share   MTVA   The Nasdaq Stock Market LLC

      

    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 7.01Regulation FD Disclosure.

     

    On July 9, 2026, MetaVia Inc. (the “Company”) issued a press release announcing that all enrolled active patients in Part 3 of its Phase 1 clinical trial evaluating DA-1726 for the treatment of obesity (the “Phase 1 Trial”) have successfully completed dose titration and are now receiving their highest target doses in both study cohorts, and that topline data from the Phase 1 Trial is on track to be released in the fourth quarter of 2026. A copy of the press release is attached as Exhibit 99.1 to this Current Report on Form 8-K (this “Report”) and is incorporated herein by reference.

     

    Information contained on or accessible through any website reference in the press release is not part of, or incorporated by reference in, this Report, and the inclusion of such website addresses in this Report by incorporation by reference of the press release is as inactive textual references only.

     

    The information in Item 7.01 of this Report, including Exhibit 99.1 attached hereto, is furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that Section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such filing. The Company’s submission of this Report shall not be deemed an admission as to the materiality of any information required to be disclosed solely to satisfy the requirements of Regulation FD.

     

    Item 8.01Other Events.

     

    On July 9, 2026, the Company provided an update on its ongoing Part 3 of its Phase 1 clinical trial evaluating DA-1726 for the treatment of obesity, reporting that all enrolled active patients in the trial have successfully completed dose titration and are now receiving their highest target doses of 48 mg and 64 mg in both study cohorts. The Company is still planning to release the data readout for Part 3 of its Phase 1 clinical trial evaluating DA-1726 in the fourth quarter of 2026.

     

    Forward-Looking Statements

     

    This Report, including Exhibit 99.1 attached hereto, contains forward-looking statements within the meaning of the federal securities laws. These forward-looking statements are based on current expectations and are not guarantees of future performance. Further, the forward-looking statements are subject to the limitations listed in Exhibit 99.1 and in the other reports that the Company has filed with the Securities and Exchange Commission, including that actual events or results may differ materially from those in the forward-looking statements.

     

    Item 9.01.Financial Statements and Exhibits.

     

    (d) Exhibits

     

         
    Exhibit
    Number
      Exhibit Description
    99.1   Press Release dated July 9, 2026.
    104   Cover Page Interactive Data File (embedded within Inline XBRL document).

     

     

     

     

    SIGNATURES

     

    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.

     

      MetaVia Inc.
         
    Date: July 9, 2026 By: /s/ Hyung Heon Kim
        Hyung Heon Kim
        President and Chief Executive Officer

     

     

     

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