Zenkuda (Tarcocimab tedromer (KSI-501)) - (DAYBREAK)

Sept. 28, 2026: Kodiak Sciences (NASDAQ: KOD) reported that both Zenkuda (tarcocimab tedromer) and tabirafusp alfa tedromer (tabirafusp-ted/KSI-501) met the primary endpoint in the Phase 3 DAYBREAK trial in wet age-related macular degeneration, achieving non-inferior vision gains versus aflibercept at one year.

For Zenkuda, the primary endpoint was met with p=0.0007. The company said Zenkuda showed rapid effect through loading and durability, with 54% of patients on 6-month dosing at year one under treat-to-dryness retreatment criteria. Safety was described as consistent with aflibercept, including 0% intraocular inflammation and 0.5% cataract adverse events versus 0.9% for aflibercept. Kodiak plans a multi-indication/three-indication BLA in 4Q 2026 supported by five positive Phase 3 studies: DAYBREAK and DAYLIGHT in wAMD, GLOW1/GLOW2 in diabetic retinopathy, and BEACON in retinal vein occlusion.

For tabirafusp-ted, the vision primary endpoint was met with p=0.0036 and the anatomical key secondary endpoint with p<0.0001. Safety included 0.4% intraocular inflammation and 0% cataract adverse events. Post-hoc analyses are planned in treatment-naive wAMD subgroups, and the Phase 3 ALTO study in diabetic macular edema is actively enrolling.

Kodiak also said topline Phase 3 PEAK data for KSI-101 in macular edema secondary to inflammation are expected in December 2026, with a planned BLA in 2Q 2027.