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    Vanda Pharmaceuticals Inc. filed SEC Form 8-K: Other Events, Financial Statements and Exhibits

    1/8/26 7:09:31 AM ET
    $VNDA
    Biotechnology: Pharmaceutical Preparations
    Health Care
    Get the next $VNDA alert in real time by email
    vnda-20260107
    0001347178FALSE00013471782026-01-072026-01-07

    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): January 7, 2026
    VANDA PHARMACEUTICALS INC.
    (Exact name of Registrant as specified in its charter)
    Delaware001-3418603-0491827
    (State or other jurisdiction of incorporation)(Commission File No.)(IRS Employer Identification No.)
    2200 Pennsylvania Avenue NW
    Suite 300E
    Washington, DC 20037
    (Address of principal executive offices and zip code)
    Registrant’s telephone number, including area code: (202) 734-3400
    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 (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 classTrading Symbol(s)Name of each exchange on which registered
    Common Stock, par value $0.001 per shareVNDAThe Nasdaq Global 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.
    As previously disclosed, on October 1, 2025, Vanda Pharmaceuticals Inc. (“Vanda”) announced that it had reached a collaborative framework with the U.S. Food and Drug Administration (the “FDA”) pursuant to which, among other things, the FDA had agreed to conduct an expedited re-review of Vanda’s supplemental New Drug Application (the “sNDA”) for HETLIOZ® for the treatment of jet lag disorder by January 7, 2026. On January 7, 2026, Vanda received a letter from the FDA stating that, following this re-review, it had concluded that the sNDA cannot be approved in its current form. On January 8, 2026, Vanda issued a press release regarding the FDA’s conclusion.
    The full text of the press release is attached hereto as Exhibit 99.1 and incorporated by reference herein.
    Item 9.01.Financial Statements and Exhibits.
     
    (d)Exhibits

    Exhibit No.  Description
    99.1 
    Press release of Vanda Pharmaceuticals Inc. dated January 8, 2026.
    104Cover 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.

    Dated:January 8, 2026 VANDA PHARMACEUTICALS INC.
     By:/s/ Timothy Williams
     Name:Timothy Williams
     Title:Senior Vice President, General Counsel and Secretary

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