{"schema_version":"secwatch.filing_event.v1","accession":"0001193125-25-153465","form_type":"8-K","ticker":"COYA","cik":"0001835022","company_name":"Coya Therapeutics, Inc.","filed_at":"2025-07-01T23:59:59+00:00","discovered_at":"2026-05-14T18:02:45.223385+00:00","generated_at":"2026-05-18T10:26:52.657934+00:00","sec_items":["8.01"],"event_type":"regulatory","sentiment":"neutral","materiality_score":0.6,"calibrated_materiality_score":0.6,"confidence":"high","headline":"Coya re-submits IND for COYA 302 ALS Phase 2 study after FDA request","bullets":["Re-submitted IND to FDA on June 30, 2025, including requested non-clinical data.","Previous FDA request on July 14, 2024, for additional non-clinical data.","Plans to initiate Phase 2 study upon IND acceptance.","Study: randomized, double-blind, placebo-controlled, 24-week with 24-week OLE, evaluating COYA 302 for ALS."],"urls":{"canonical":"https://secwatch.observer/filing/0001193125-25-153465","json":"https://secwatch.observer/filing/0001193125-25-153465.json","markdown":"https://secwatch.observer/filing/0001193125-25-153465.md","text":"https://secwatch.observer/filing/0001193125-25-153465.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1835022/000119312525153465/0001193125-25-153465-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1835022/000119312525153465/d17294d8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-18T10:26:52.657934+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"}