{"schema_version":"secwatch.filing_event.v1","accession":"0001193125-24-178809","form_type":"8-K","ticker":"COYA","cik":"0001835022","company_name":"Coya Therapeutics, Inc.","filed_at":"2024-07-15T23:59:59+00:00","discovered_at":"2026-05-14T18:03:14.796514+00:00","generated_at":"2026-05-31T20:49:16.858339+00:00","sec_items":["8.01"],"event_type":"regulatory","sentiment":"negative","materiality_score":0.65,"calibrated_materiality_score":0.65,"confidence":"high","headline":"Coya Therapeutics FDA requires additional non-clinical data before initiating Phase 2 ALS trial for COYA 302","bullets":["Submitted IND for Phase 2 double-blind, placebo-controlled study of COYA 302 in ALS on June 14, 2024.","FDA notified on July 12, 2024 that additional non-clinical data is required prior to study initiation.","FDA will provide details on required data within 30 days.","Study was designed as 24-week treatment phase with 24-week open-label extension.","Regulatory delay may push back clinical timeline for COYA 302."],"urls":{"canonical":"https://secwatch.observer/filing/0001193125-24-178809","json":"https://secwatch.observer/filing/0001193125-24-178809.json","markdown":"https://secwatch.observer/filing/0001193125-24-178809.md","text":"https://secwatch.observer/filing/0001193125-24-178809.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1835022/000119312524178809/0001193125-24-178809-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1835022/000119312524178809/d762748d8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-31T20:49:16.858339+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"}