secwatch.observer — SEC 8-K summary
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Issuer:     Coya Therapeutics, Inc. (COYA)
CIK:        0001835022
Form:       8-K
Filed at:   2026-09-15T12:15:06+00:00
Accession:  0001193125-26-391378
Event type: other_material
Sentiment:  positive
Materiality: 0.55
Item codes: 8.01
LLM model:  deepseek-v4-flash:cloud@v2

Coya Therapeutics hits 100th patient enrollment in Phase 2/3 ALSTARS trial for COYA 302 in ALS
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- 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.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1835022/000119312526391378/0001193125-26-391378-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1835022/000119312526391378/d896544d8k.htm
  HTML page:      https://secwatch.observer/filing/0001193125-26-391378

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