secwatch.observer — SEC 8-K summary
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Issuer:     Aardvark Therapeutics, Inc. (AARD)
CIK:        0001774857
Form:       8-K
Filed at:   2026-05-14T20:15:34+00:00
Accession:  0001193125-26-224069
Event type: regulatory
Sentiment:  negative
Materiality: 0.90
Item codes: 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

FDA places full clinical hold on Aardvark's ARD-101 IND; HERO and OLE trials paused
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- FDA full clinical hold on IND for ARD-101, affecting Phase 3 HERO trial (AVK-101-301) and OLE trial (AVK-101-302).
- Company to unblind accumulated data from 68 HERO patients and 19 OLE patients to inform next steps.
- Cash of $91.2M as of March 31, 2026, expected to fund operations into mid-2027.
- Active discussions with FDA ongoing to resolve clinical hold and determine path forward.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1774857/000119312526224069/0001193125-26-224069-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1774857/000119312526224069/ck0001774857-20260514.htm
  HTML page:      https://secwatch.observer/filing/0001193125-26-224069

License: Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer