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    SEC Form 8-K filed by Savara Inc.

    5/27/25 8:13:24 AM ET
    $SVRA
    Biotechnology: Pharmaceutical Preparations
    Health Care
    Get the next $SVRA alert in real time by email
    8-K
    Savara Inc PA false 0001160308 0001160308 2025-05-27 2025-05-27
     
     

    UNITED STATES

    SECURITIES AND EXCHANGE COMMISSION

    Washington, DC 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)

    May 27, 2025

     

     

    SAVARA INC.

    (Exact name of registrant as specified in its charter)

     

     

     

    Delaware   001-32157   84-1318182

    (State or other jurisdiction

    of incorporation)

     

    (Commission

    File Number)

     

    (IRS Employer

    Identification No.)

    1717 Langhorne Newtown Road, Suite 300

    Langhorne, PA 19047

    (Address of principal executive offices, including zip code)

    (512) 614-1848

    (Registrant’s telephone number, including area code)

    N/A

    (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 (see General Instruction A.2. below):

     

    ☐

    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   SVRA   The Nasdaq Global Select Market

    Indicate by check mark whether the registrant is an emerging growth company as defined in 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 May 27, 2025, Savara Inc. issued a press release announcing that it has received a refusal to file letter from the U.S. Food and Drug Administration for the Biologics License Application for molgramostim inhalation solution to treat patients with autoimmune pulmonary alveolar proteinosis. A copy of the press release is attached hereto as Exhibit 99.1 to this Current Report on 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 Savara Inc. dated May 27, 2025
    104    Cover Page Interactive Data File (embedded within the 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.

     

    Date: May 27, 2025

          SAVARA INC.
    a Delaware corporation
        By:  

    /s/ Dave Lowrance

         

    Dave Lowrance

    Chief Financial & Administrative Officer

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