---
schema_version: "secwatch.filing_event.v1"
accession: "0001193125-26-428943"
form_type: "8-K"
ticker: "AARD"
cik: "0001774857"
company_name: "Aardvark Therapeutics, Inc."
filed_at: "2026-10-22T20:17:09+00:00"
generated_at: "2026-10-22T20:18:06.788805+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.72
calibrated_materiality_score: 0.72
confidence: "high"
source: SEC EDGAR
---

# FDA lifts clinical hold on Aardvark's ARD-101 for Prader-Willi syndrome hyperphagia

## Summary
- Clinical hold lifted Oct. 22, 2026; Aardvark says development of ARD-101 in PWS hyperphagia may resume.
- Hold followed Feb. 27, 2026 voluntary dosing pause in Phase 3 HERO and OLE trials after reversible ECG changes seen in a separate healthy-volunteer study; FDA imposed hold in May 2026.
- New ECG study at 200 mg and 400 mg twice daily showed no cardiac events; in vitro NaV1.5 cardiac sodium channel study also completed with FDA alignment.
- Aardvark unblinded data from the terminated HERO and OLE trials; will review the available exploratory dataset on a webcast Oct. 23, 2026 at 8:00 a.m. ET.
- Resumption timing depends on further FDA engagement on Phase 3 trial design; CEO Tien Lee cited 'profound unmet need' in PWS.

## SEC filing metadata
- accession: 0001193125-26-428943
- form_type: 8-K
- ticker: AARD
- cik: 0001774857
- company_name: Aardvark Therapeutics, Inc.
- filed_at: 2026-10-22T20:17:09+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.72
- calibrated_materiality_score: 0.72
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1774857/000119312526428943/0001193125-26-428943-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1774857/000119312526428943/ck0001774857-20261022.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001193125-26-428943
- JSON: https://secwatch.observer/filing/0001193125-26-428943.json
- Plain text: https://secwatch.observer/filing/0001193125-26-428943.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.