secwatch.observer — SEC 8-K summary
======================================

Issuer:     Aardvark Therapeutics, Inc. (AARD)
CIK:        0001774857
Form:       8-K
Filed at:   2026-02-10T23:59:59+00:00
Accession:  0001193125-26-043764
Event type: regulatory
Sentiment:  positive
Materiality: 0.65
Item codes: 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Aardvark Therapeutics expands Phase 3 HERO trial age eligibility to 7+ years for ARD-101 in PWS
--------------------------------------------------------------------------------

- IRB approved amended protocol lowering minimum age from 10 to 7 years for Phase 3 HERO trial evaluating ARD-101.
- Amended protocol submitted to FDA; enrollment on track for topline data in Q3 2026.
- Trial targets 90 patients across US, Australia, Canada, UK, and South Korea.
- Primary endpoint: change in HQ-CT score at 12 weeks; open-label extension offered to completers.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1774857/000119312526043764/0001193125-26-043764-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1774857/000119312526043764/ck0001774857-20260210.htm
  HTML page:      https://secwatch.observer/filing/0001193125-26-043764

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