{"schema_version":"secwatch.filing_event.v1","accession":"0001193125-26-391378","form_type":"8-K","ticker":"COYA","cik":"0001835022","company_name":"Coya Therapeutics, Inc.","filed_at":"2026-09-15T12:15:06+00:00","discovered_at":"2026-09-15T12:20:02.386119+00:00","generated_at":"2026-09-15T12:20:26.048113+00:00","sec_items":["8.01"],"event_type":"other_material","sentiment":"positive","materiality_score":0.55,"calibrated_materiality_score":0.55,"confidence":"high","headline":"Coya Therapeutics hits 100th patient enrollment in Phase 2/3 ALSTARS trial for COYA 302 in ALS","bullets":["100th patient enrolled in Phase 2/3 ALSTARS trial (NCT07161999) evaluating COYA 302 for ALS as of Sept 15, 2026.","Trial targets 120 total participants; enrollment trending to complete in time for topline data in early Q2 2027.","Study is randomized, double-blind, placebo-controlled, 1:1:1 dosing: two COYA 302 regimens vs placebo over 24 weeks, then 24-week active extension.","Primary endpoint: change in ALSFRS-R total score from baseline to Week 24 vs placebo; also evaluates safety, biomarkers.","COYA 302 combines proprietary low-dose IL-2 and CTLA-4 Ig; FDA Fast Track designation previously granted."],"urls":{"canonical":"https://secwatch.observer/filing/0001193125-26-391378","json":"https://secwatch.observer/filing/0001193125-26-391378.json","markdown":"https://secwatch.observer/filing/0001193125-26-391378.md","text":"https://secwatch.observer/filing/0001193125-26-391378.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1835022/000119312526391378/0001193125-26-391378-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1835022/000119312526391378/d896544d8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-09-15T12:20:26.048113+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"}