secwatch.observer — SEC 8-K summary
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Issuer:     Aardvark Therapeutics, Inc. (AARD)
CIK:        0001774857
Form:       8-K
Filed at:   2026-10-22T20:17:09+00:00
Accession:  0001193125-26-428943
Event type: regulatory
Sentiment:  positive
Materiality: 0.72
Item codes: 8.01, 9.01
LLM model:  deepseek-v4.1-flash:cloud@v2

FDA lifts clinical hold on Aardvark's ARD-101 for Prader-Willi syndrome hyperphagia
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- Clinical hold lifted Oct. 22, 2026; Aardvark says development of ARD-101 in PWS hyperphagia may resume.
- Hold followed Feb. 27, 2026 voluntary dosing pause in Phase 3 HERO and OLE trials after reversible ECG changes seen in a separate healthy-volunteer study; FDA imposed hold in May 2026.
- New ECG study at 200 mg and 400 mg twice daily showed no cardiac events; in vitro NaV1.5 cardiac sodium channel study also completed with FDA alignment.
- Aardvark unblinded data from the terminated HERO and OLE trials; will review the available exploratory dataset on a webcast Oct. 23, 2026 at 8:00 a.m. ET.
- Resumption timing depends on further FDA engagement on Phase 3 trial design; CEO Tien Lee cited 'profound unmet need' in PWS.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1774857/000119312526428943/0001193125-26-428943-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1774857/000119312526428943/ck0001774857-20261022.htm
  HTML page:      https://secwatch.observer/filing/0001193125-26-428943

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