{"schema_version":"secwatch.filing_event.v1","accession":"0001193125-26-421066","form_type":"8-K","ticker":"COYA","cik":"0001835022","company_name":"Coya Therapeutics, Inc.","filed_at":"2026-10-14T12:30:08+00:00","discovered_at":"2026-10-14T12:35:00.206046+00:00","generated_at":"2026-10-14T12:35:03.727228+00:00","sec_items":["8.01"],"event_type":"other_material","sentiment":"neutral","materiality_score":0.5,"calibrated_materiality_score":0.5,"confidence":"high","headline":"Coya to launch OLE of COYA 302 ALS trial in Nov 2026; FTD Phase 2 slips to 2027","bullets":["Open-label extension of the Phase 2/3 ALSTARS Trial (NCT07161999) for COYA 302 in ALS expected to begin November 2026 as the first cohort completes the 48-week treatment period.","OLE initiated in response to requests from ALSTARS investigators and participants; it will gather longer-term efficacy and safety data on COYA 302.","Phase 2 trial of COYA 302 in frontotemporal dementia, previously expected in H2 2026, is now expected in 2027 as resources are prioritized to the ALS program.","Cash runway guidance unchanged: existing cash expected to fund operations into H2 2027, beyond the anticipated ALSTARS topline readout.","ALSTARS design: ~120 patients randomized 1:1:1; 24-week double-blind phase plus 24-week blinded active extension; primary endpoint is ALSFRS-R change at Week 24."],"urls":{"canonical":"https://secwatch.observer/filing/0001193125-26-421066","json":"https://secwatch.observer/filing/0001193125-26-421066.json","markdown":"https://secwatch.observer/filing/0001193125-26-421066.md","text":"https://secwatch.observer/filing/0001193125-26-421066.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1835022/000119312526421066/0001193125-26-421066-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1835022/000119312526421066/d172621d8k.htm"},"model":{"generated_by":"deepseek-v4.1-flash:cloud@v2","generated_at":"2026-10-14T12:35:03.727228+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"}