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

    7/17/25 7:01:40 AM ET
    $ALDX
    Biotechnology: Pharmaceutical Preparations
    Health Care
    Get the next $ALDX alert in real time by email
    false 0001341235 0001341235 2025-07-17 2025-07-17 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 17, 2025

     

     

     

    ALDEYRA THERAPEUTICS, INC.

    (Exact name of Registrant as specified in its charter)

     

     

     

    Delaware   001-36332   20-1968197

    (State or other jurisdiction

    of incorporation)

     

    (Commission File No.)

     

    (IRS Employer

    Identification No.)

     

    131 Hartwell Avenue, Suite 320

    Lexington, MA 02421

    (Address of principal executive offices and zip code)

     

    Registrant’s telephone number, including area code: (781) 761-4904

     

    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, $0.001 par value per share   ALDX   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 8.01. Other Events.

     

    On July 17, 2025, the Aldeyra Therapeutics, Inc. (“Aldeyra”) issued a press release (the “Press Release”) to announce that the U.S. Food and Drug Administration (“FDA”) has accepted for review Aldeyra’s resubmitted New Drug Application (“NDA”) for reproxalap, a first-in-class investigational new drug candidate, for the treatment of the signs and symptoms of dry eye disease, and has assigned a Prescription Drug User Fee Act (“PDUFA”) target action date of December 16, 2025. The Press Release is filed as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated by reference herein.

     

    Item 9.01. Financial Statements and Exhibits.

     

    (d) Exhibits

     

    Exhibit No.   Description
    99.1   Aldeyra Therapeutics, Inc. Press Release dated July 17, 2025
         
    104   Cover Page Interactive Data File (embedded within the Inline XBRL document)

     

    1

     

     

    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.

     

    Dated July 17, 2025

     

      ALDEYRA THERAPEUTICS, INC.
         
      By: /s/ Todd C. Brady
        Name:  Todd C. Brady M.D., Ph.D.
        Title: Chief Executive Officer

     

     

    2

     

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