Full enrollment removes a key execution risk, but the stock will remain binary on topline data in early Q2 2027. Monitor for any interim analyses or safety updates before that catalyst.
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Executive Summary
Coya Therapeutics announced full enrollment of 120 patients in its Phase 2/3 ALSTARS trial (NCT07161999) evaluating COYA 302 for ALS. Topline data from the double-blind treatment phase is expected in early Q2 2027. This is a routine operational milestone with no financial data or binary catalyst yet.
Key Facts
- Full enrollment of planned 120 patients in Phase 2/3 ALSTARS trial (COYA 302 for ALS) announced October 5, 2026.
- Topline data from the 24-week double-blind treatment phase anticipated in early Q2 2027.
- Trial is randomized 1:1:1 to two dosing regimens of COYA 302 or placebo, with a 24-week blinded active-treatment extension.
- Primary endpoint: change in ALSFRS-R total score from baseline to Week 24 vs placebo.
Financial Impact
No financial figures disclosed; pre-revenue clinical-stage biotech.
Risk Factors
- Phase 2/3 trial failure risk — COYA 302 may not meet primary endpoint.
- No revenue or near-term cash flow; reliance on financing for ongoing operations.
- Competing ALS therapies could diminish commercial opportunity if COYA 302 succeeds.
Investment Themes
Documents Analyzed
This report is based on 4 SEC documents filed with EDGAR.
| Document | Accession Number |
|---|---|
| 8-K Filing (Primary) | 0001193125-26-413218 |
| Document: 0001193125-26-413218-index-headers.html | 0001193125-26-413218 |
| Document: 0001193125-26-413218-index.html | 0001193125-26-413218 |
| Document: 0001193125-26-413218.txt | 0001193125-26-413218 |
Filters
| Type | Now | ||||
|---|---|---|---|---|---|
Oct 14, 2026 13d ago | 8-K | $4.18 | awaiting T+20 | — | $3.95 (−5.50%) |
Oct 5, 2026 22d ago | 8-K | $4.85 | awaiting T+20 | — | $3.95 (−18.56%) |
Sep 15, 2026 6w ago | 8-K | $4.65 $4.48 | ▼ −3.76% | ▼ −6.74% | $3.95 (−15.05%) |
Aug 11, 2026 11w ago | 8-K | $4.80 $4.61 | ▼ −3.96% | ▼ −2.90% | $3.95 (−17.71%) |
May 12, 2026 24w ago | 8-K | $4.29 $4.41 | ▲ +2.80% | ▲ +4.52% | $3.95 (−7.93%) |
Apr 2, 2026 29w ago | 8-K | $4.01 $4.23 | ▲ +5.49% | ▼ −4.39% | $3.95 (−1.50%) |
Mar 23, 2026 31w ago | EFFECT | $4.22 $4.53 | ▲ +7.35% | ▼ −0.07% | $3.95 (−6.40%) |
Mar 16, 2026 32w ago | S-3 | $4.50 $4.46 | ▼ −0.89% | ▼ −4.67% | $3.95 (−12.22%) |
US Market Status
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