Kodiak Sciences says Zenkuda and tabirafusp-ted meet Phase 3 primary endpoints
Kodiak Sciences reported that both Zenkuda and tabirafusp-ted met the primary endpoints in the Phase 3 DAYBREAK study in wet age-related macular degeneration, with both achieving non-inferiority in vision gains versus aflibercept at year one. The company plans to submit a multi-indication biologics license application for Zenkuda in the fourth quarter of 2026.
Key points
- Zenkuda met its primary endpoint with a p-value of 0.0007, and 54% of patients were on 6-month dosing
- Tabirafusp-ted met its vision primary endpoint (p-value of 0.0036) and its anatomical key secondary endpoint (p-value of less than 0.0001)
- Kodiak plans to submit a Zenkuda BLA in 4Q2026 covering five positive Phase 3 studies in wet AMD, diabetic retinopathy and retinal vein occlusion
- Zenkuda showed a 0% intraocular inflammation rate in the study, and tabirafusp-ted showed 0.4%, per the press release
The filing
Written by AI on Nov 9, 2026, 10:08 AM ET, from this filing only. Written later: this filing was briefed after the fact, when past filings were added to the site, so the brief may be read with hindsight; the filing itself is the record of what was known on September 28, 2026.
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