---
schema_version: "secwatch.filing_event.v1"
accession: "0001193125-26-224069"
form_type: "8-K"
ticker: "AARD"
cik: "0001774857"
company_name: "Aardvark Therapeutics, Inc."
filed_at: "2026-05-14T20:15:34+00:00"
generated_at: "2026-05-14T20:52:00.919513+00:00"
event_type: "regulatory"
sentiment: "negative"
materiality_score: 0.9
calibrated_materiality_score: 0.9
confidence: "high"
source: SEC EDGAR
---

# FDA places full clinical hold on Aardvark's ARD-101 IND; HERO and OLE trials paused

## Summary
- FDA full clinical hold on IND for ARD-101, affecting Phase 3 HERO trial (AVK-101-301) and OLE trial (AVK-101-302).
- Company to unblind accumulated data from 68 HERO patients and 19 OLE patients to inform next steps.
- Cash of $91.2M as of March 31, 2026, expected to fund operations into mid-2027.
- Active discussions with FDA ongoing to resolve clinical hold and determine path forward.

## SEC filing metadata
- accession: 0001193125-26-224069
- form_type: 8-K
- ticker: AARD
- cik: 0001774857
- company_name: Aardvark Therapeutics, Inc.
- filed_at: 2026-05-14T20:15:34+00:00
- event_type: regulatory
- sentiment: negative
- materiality_score: 0.9
- calibrated_materiality_score: 0.9
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1774857/000119312526224069/0001193125-26-224069-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1774857/000119312526224069/ck0001774857-20260514.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001193125-26-224069
- JSON: https://secwatch.observer/filing/0001193125-26-224069.json
- Plain text: https://secwatch.observer/filing/0001193125-26-224069.txt

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