FDA, Aardvark (Nasdaq: AARD) align on younger HERO trial enrollment

Rhea-AI Filing Summary

Aardvark Therapeutics, Inc. reported that it has reached alignment with the U.S. Food and Drug Administration on a protocol amendment to its Phase 3 HERO trial of ARD-101 for treating hyperphagia associated with Prader-Willi Syndrome.

The amendment lowers the minimum age for trial eligibility from 13 to 10 years old, allowing younger patients with this condition to participate in the Phase 3 study. The company announced this change in a press release dated October 8, 2025, which is included as an exhibit to the report.

false000177485700017748572025-10-082025-10-08

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): October 08, 2025

Aardvark Therapeutics, Inc.

(Exact name of Registrant as Specified in Its Charter)

Delaware			001-42513	82-1606367
(State or Other Jurisdiction of Incorporation)			(Commission File Number)	(IRS Employer Identification No.)
4370 La Jolla Village Drive, Suite 1050
San Diego, California				92122
(Address of Principal Executive Offices)				(Zip Code)

Registrant’s Telephone Number, Including Area Code: (858) 225-7696

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:

☐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 $0.00001 per share		AARD		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 October 8, 2025, Aardvark Therapeutics, Inc. (the “Company”) issued a press release announcing alignment with the U.S. Food and Drug Administration on a protocol amendment to the Company's Phase 3 HERO trial of ARD-101 for the treatment of hyperphagia associated with Prader-Willi Syndrome. The protocol amendment changes the minimum age of eligibility to participate in the trial from 13 to 10 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.

Exhibit No.		Description
99.1		Press Release, dated October 8, 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.

			AARDVARK THERAPEUTICS, INC.
Date:	October 8, 2025	By:	/s/ Tien-Li Lee, M.D.
			Tien-Li Lee, M.D. Chief Executive Officer

FAQ

What did Aardvark Therapeutics (AARD) announce in this 8-K?

Aardvark Therapeutics announced that it has aligned with the U.S. Food and Drug Administration on a protocol amendment to its Phase 3 HERO trial of ARD-101 for the treatment of hyperphagia associated with Prader-Willi Syndrome.

How is the Phase 3 HERO trial eligibility changing for AARD?

The protocol amendment changes the minimum age of eligibility to participate in the Phase 3 HERO trial from 13 years old to 10 years old.

Which condition is Aardvark Therapeutics studying with ARD-101?

Aardvark Therapeutics is studying ARD-101 for the treatment of hyperphagia associated with Prader-Willi Syndrome in its Phase 3 HERO trial.

What role did the FDA play in Aardvark Therapeutics' trial update?

The company stated that it achieved alignment with the U.S. Food and Drug Administration on the protocol amendment that changes the age eligibility criteria for the Phase 3 HERO trial.

When did Aardvark Therapeutics issue the press release about the HERO trial change?

The press release describing the protocol amendment to the Phase 3 HERO trial was dated October 8, 2025.

What exhibit is attached to Aardvark Therapeutics' 8-K filing?

The filing includes Exhibit 99.1, which is the press release dated October 8, 2025, and Exhibit 104, the cover page interactive data file embedded within the Inline XBRL document.