secwatch.observer — SEC 8-K summary
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Issuer:     Aardvark Therapeutics, Inc. (AARD)
CIK:        0001774857
Form:       8-K
Filed at:   2025-12-10T23:59:59+00:00
Accession:  0001193125-25-314364
Event type: other_material
Sentiment:  positive
Materiality: 0.70
Item codes: 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Aardvark doses first patient in Australia Phase 3 HERO trial; Q3 2026 data readout on track
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- First patient dosed in Australia in Phase 3 HERO trial for ARD-101 for hyperphagia in Prader-Willi syndrome.
- Regulatory clearance received for clinical trial sites in Canada and UK; EU sites not needed for full enrollment.
- All patients completing the 12-week HERO trial have enrolled in the Open Label Extension, indicating strong patient interest.
- Topline data readout remains on track for Q3 2026 driven by strong US enrollment and international progress.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1774857/000119312525314364/0001193125-25-314364-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1774857/000119312525314364/ck0001774857-20251210.htm
  HTML page:      https://secwatch.observer/filing/0001193125-25-314364

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