Aardvark Therapeutics, Inc. (AARD): Form 8-K filed 2026-11-13

Accepted by EDGAR: 2026-11-13 08:18 ET
Event date: 2026-11-13
Accession no.: 0001193125-26-459373
Original filing: SEC EDGAR filing index

AI summary of the filing text. It can contain mistakes; the original filing is authoritative.

Aardvark reports third-quarter results and FDA lifting of ARD-101 clinical hold

Aardvark reported a third-quarter net loss of $19.2 million and $60.3 million in cash, cash equivalents and short-term investments. The FDA lifted the ARD-101 clinical hold in October 2026 and agreed to an open-label trial at 200 mg BID in patients with Prader-Willi Syndrome. The company expects to resume PWS clinical activities in 2027, subject to alignment with the FDA.

Third quarter of 2026 net loss was $19.2 million, compared to $16.3 million for the third quarter of 2025.
Cash, cash equivalents and short-term investments totaled $60.3 million as of September 30, 2026.
In October 2026, the FDA lifted the clinical hold on ARD-101 for hyperphagia in Prader-Willi Syndrome.
An FDA meeting is scheduled for the first quarter of 2027 to discuss the proposed ARD-101 clinical development plan.

earningsregulatoryproduct

Items reported

Item 2.02: Results of Operations and Financial Condition
The company publicly announced results of operations or financial condition for a completed period, most often a quarterly earnings release. The release itself is usually attached as Exhibit 99.1. Information under Item 2.02 is generally "furnished" rather than "filed".
Item 9.01: Financial Statements and Exhibits
Lists the financial statements, pro forma information and exhibits filed with the report. It almost always accompanies another Item and is rarely news on its own.

Documents

Type	Description	Document
8-K	8-K	ck0001774857-20261113.htm
EX-99.1	EX-99.1	ck0001774857-ex99_1.htm

The summary above was generated by AI from the filing text and checked automatically against it. Read the original documents on SEC EDGAR. How to read an 8-K.