Every material Form 8-K Coya Therapeutics, Inc. has filed with the SEC since September 15, 2026, read and summarized by AI: what happened, the key figures, whether it reads positive or negative for shareholders, and how big a deal it is (impact 1-5). Newest first; each brief links to its own page and to the filing on SEC.gov.
Coya Therapeutics plans to start an open-label extension of its Phase 2/3 ALSTARS trial of COYA 302 in ALS in November 2026, in response to requests from investigators and participants. To prioritize the ALS program, the company now expects its Phase 2 trial of COYA 302 in frontotemporal dementia to start in 2027 rather than the second half of 2026, while its cash runway guidance is unchanged.
Open-label extension expected to begin in November 2026, as the first cohort completes the 48-week treatment period
Phase 2 trial in frontotemporal dementia now expected in 2027, previously anticipated in the second half of 2026
Cash resources expected to fund operations into the second half of 2027, beyond the anticipated ALSTARS topline data readout
ALSTARS trial to randomize approximately 120 subjects; primary endpoint is change in ALSFRS-R total score at Week 24 versus placebo
Coya Therapeutics announced that it has fully enrolled the planned 120 patients in its ongoing Phase 2/3 ALSTARS trial evaluating COYA 302 for amyotrophic lateral sclerosis (ALS). Topline data from the double-blind treatment phase are expected in early Q2 2027, a key clinical milestone for the company's lead program.
Full enrollment of the planned 120 patients in the ALSTARS Trial (NCT07161999) announced October 5, 2026
Additional participants already in active screening may enroll if deemed eligible
Topline data from the 24-week double-blind treatment phase anticipated in early Q2 2027
Primary endpoint is change in ALSFRS-R total score from baseline to Week 24 compared with placebo
Coya Therapeutics said the 100th patient has been enrolled in its ongoing Phase 2/3 ALSTARS Trial of COYA 302 for amyotrophic lateral sclerosis (ALS). The company expects to complete enrollment of 120 participants and report topline data in early Q2 of 2027, based on current enrollment trends.
100th patient enrolled in the ALSTARS Trial (NCT07161999) as of September 15, 2026
Full enrollment of 120 participants expected, with topline data targeted for early Q2 2027
Primary endpoint is change in ALSFRS-R total score from baseline to Week 24 compared with placebo
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