{"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","discovered_at":"2026-10-22T20:18:00.247117+00:00","generated_at":"2026-10-22T20:18:06.788805+00:00","sec_items":["8.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.72,"calibrated_materiality_score":0.72,"confidence":"high","headline":"FDA lifts clinical hold on Aardvark's ARD-101 for Prader-Willi syndrome hyperphagia","bullets":["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."],"urls":{"canonical":"https://secwatch.observer/filing/0001193125-26-428943","json":"https://secwatch.observer/filing/0001193125-26-428943.json","markdown":"https://secwatch.observer/filing/0001193125-26-428943.md","text":"https://secwatch.observer/filing/0001193125-26-428943.txt","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"},"model":{"generated_by":"deepseek-v4.1-flash:cloud@v2","generated_at":"2026-10-22T20:18:06.788805+00:00"},"review":{"review_status":"machine_generated","human_reviewed":false,"corrected":false,"correction_note":null,"correction_timestamp":null,"superseded_by":null,"related_filings":[]},"source_grounded_claims":[],"license":"Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer"}