secwatch.observer — SEC 8-K summary
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Issuer:     Aardvark Therapeutics, Inc. (AARD)
CIK:        0001774857
Form:       8-K
Filed at:   2026-02-27T23:59:59+00:00
Accession:  0001193125-26-082787
Event type: other_material
Sentiment:  negative
Materiality: 0.85
Item codes: 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Aardvark Therapeutics pauses Phase 3 HERO trial for ARD-101 in PWS due to cardiac signals
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- Voluntary pause of Phase 3 HERO trial (NCT06828861) and open-label extension (NCT07197034) for ARD-101 in Prader-Willi Syndrome.
- Decision based on reversible cardiac observations at above-target therapeutic doses in a healthy volunteer study.
- No longer expects topline data in Q3 2026; plans to provide guidance in Q2 2026.
- Company conducting comprehensive data review and collaborating with FDA and clinical experts.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1774857/000119312526082787/0001193125-26-082787-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1774857/000119312526082787/ck0001774857-20260227.htm
  HTML page:      https://secwatch.observer/filing/0001193125-26-082787

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