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
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Date of Report (Date of earliest event reported): February 10, 2026 |
Aardvark Therapeutics, Inc.
(Exact name of Registrant as Specified in Its Charter)
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Delaware |
001-42513 |
82-1606367 |
(State or Other Jurisdiction
of Incorporation) |
(Commission File Number) |
(IRS Employer
Identification No.) |
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4370 La Jolla Village Drive, Suite 1050 |
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San Diego, California |
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92122 |
(Address of Principal Executive Offices) |
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(Zip Code) |
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Registrant’s Telephone Number, Including Area Code: (858) 225-7696 |
(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:
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Title of each class
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Trading
Symbol(s) |
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Name of each exchange on which registered
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Common Stock, par value $0.00001 per share |
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AARD |
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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 February 10, 2026, Aardvark Therapeutics, Inc. (the “Company”) issued a press release announcing that Institutional Review Board approval has been granted in the United States for an amended protocol to its ongoing Phase 3 HERO pivotal clinical trial evaluating ARD-101 for the treatment of hyperphagia in individuals with Prader-Willi Syndrome. The amended protocol, submitted to the U.S. Food and Drug Administration, lowers the minimum age of eligibility for participation in the Phase 3 HERO pivotal clinical trial from ten to seven years old. The full text of the press release is filed as Exhibit 99.1 to this Current Report on Form 8-K and incorporated herein by reference.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits.
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.
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AARDVARK THERAPEUTICS, INC. |
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Date: |
February 10, 2026 |
By: |
/s/ Tien-Li Lee, M.D. |
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Tien-Li Lee, M.D.
Chief Executive Officer |