Kodiak's Zenkuda, tabirafusp-ted hit primary endpoints in Phase 3 DAYBREAK wAMD trial; Zenkuda BLA set for 4Q2026

Kodiak Sciences Inc.

Zenkuda (tarcocimab tedromer) met the vision primary endpoint with p=0.0007; 54% of patients maintained 24-week dosing at year one under strict treat-to-dryness retreatment criteria.
Tabirafusp-ted (KSI-501) met the vision primary endpoint (p=0.0036) and the anatomical key secondary endpoint (p<0.0001); both agents achieved non-inferiority vs aflibercept at year one.
Zenkuda safety: 0% intraocular inflammation and 0.5% cataract rate (vs 0.9% for aflibercept); tabirafusp-ted showed 0.4% inflammation and 0% cataract.
Kodiak plans a multi-indication Zenkuda BLA in 4Q2026 backed by five positive Phase 3 studies: DAYBREAK and DAYLIGHT (wAMD), GLOW and GLOW2 (diabetic retinopathy), BEACON (RVO).
KSI-101 Phase 3 topline in macular edema secondary to inflammation (MESI) expected December 2026; tabirafusp-ted advancing in the Phase 3 ALTO program for diabetic macular edema.

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