secwatch.observer — SEC 8-K summary
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Issuer:     Coya Therapeutics, Inc. (COYA)
CIK:        0001835022
Form:       8-K
Filed at:   2026-10-05T12:30:07+00:00
Accession:  0001193125-26-413218
Event type: other_material
Sentiment:  positive
Materiality: 0.55
Item codes: 8.01
LLM model:  deepseek-v4.1-flash:cloud@v2

Coya Therapeutics completes enrollment of 120 patients in Phase 2/3 ALSTARS trial of COYA 302 in ALS
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- 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.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1835022/000119312526413218/0001193125-26-413218-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1835022/000119312526413218/d95167d8k.htm
  HTML page:      https://secwatch.observer/filing/0001193125-26-413218

License: Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer