secwatch.observer — SEC 8-K summary
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Issuer:     Aardvark Therapeutics, Inc. (AARD)
CIK:        0001774857
Form:       8-K
Filed at:   2025-10-09T23:59:59+00:00
Accession:  0001193125-25-234722
Event type: regulatory
Sentiment:  positive
Materiality: 0.60
Item codes: 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Aardvark gets FDA alignment to lower Phase 3 PWS trial min age to 10
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- FDA aligned on protocol amendment for Phase 3 HERO trial of ARD-101, lowering minimum age from 13 to 10 years old.
- Expansion broadens patient population in Prader-Willi Syndrome; topline data readout expected in Q3 2026.
- CEO cites community support and historical data suggesting younger patients benefit from early intervention.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1774857/000119312525234722/0001193125-25-234722-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1774857/000119312525234722/ck0001774857-20251008.htm
  HTML page:      https://secwatch.observer/filing/0001193125-25-234722

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