{"schema_version":"secwatch.filing_event.v1","accession":"0001193125-26-413218","form_type":"8-K","ticker":"COYA","cik":"0001835022","company_name":"Coya Therapeutics, Inc.","filed_at":"2026-10-05T12:30:07+00:00","discovered_at":"2026-10-05T12:35:00.296893+00:00","generated_at":"2026-10-12T14:45:57.473889+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 completes enrollment of 120 patients in Phase 2/3 ALSTARS trial of COYA 302 in ALS","bullets":["Full enrollment reached at 120 patients in the Phase 2/3 ALSTARS Trial (NCT07161999) evaluating COYA 302 for ALS; additional eligible screening patients may still enroll.","Topline data from the 24-week double-blind treatment phase are anticipated in early Q2 2027.","Trial randomizes ~120 subjects 1:1:1 to one of two dosing regimens of COYA 302 (low-dose IL-2 plus CTLA-4 Ig) or placebo.","Primary endpoint is change in ALSFRS-R total score from baseline to Week 24 vs placebo; also assesses safety, biological activity and biomarkers.","Completers enter a 24-week blinded active-treatment extension, with placebo patients re-randomized to COYA 302, yielding up to 48 weeks of COYA 302 data."],"urls":{"canonical":"https://secwatch.observer/filing/0001193125-26-413218","json":"https://secwatch.observer/filing/0001193125-26-413218.json","markdown":"https://secwatch.observer/filing/0001193125-26-413218.md","text":"https://secwatch.observer/filing/0001193125-26-413218.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1835022/000119312526413218/0001193125-26-413218-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1835022/000119312526413218/d95167d8k.htm"},"model":{"generated_by":"deepseek-v4.1-flash:cloud@v2","generated_at":"2026-10-12T14:45:57.473889+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"}