Tarcocimab tedromer (KSI-501) - (DAYBREAK)

Aug. 13, 2026: Kodiak Sciences (NASDAQ: KOD) reported pipeline updates across three late-stage retina programs. In the Phase 3 DAYBREAK study in treatment-naïve wet AMD, topline one-year primary endpoint data for both Zenkuda (tarcocimab tedromer) and KSI-501 are expected in September 2026. DAYBREAK is a non-inferiority trial versus aflibercept; Zenkuda is dosed every 4-24 weeks after loading, and KSI-501 uses fixed every-8-week dosing plus as-needed dosing. Kodiak said it continues BLA preparation activities for Zenkuda.

For KSI-501 in diabetic macular edema, the global Phase 3 ALTO study has begun enrolling patients. The approximately 910-patient registrational study compares KSI-501 with aflibercept and is designed to show superiority; the primary endpoint is mean BCVA change from baseline to the average of Weeks 48 and 52.

For KSI-101 in macular edema secondary to inflammation, Kodiak completed enrollment of the first 300-patient cohort in the Phase 3 PEAK study supporting Pivotal Analysis 1, with topline data expected in December 2026. Enrollment completion for the second pivotal cohort across PEAK and PINNACLE (600 subjects total for Pivotal Analysis 2) is expected in 4Q 2026, with topline data anticipated in 2Q 2027.

Kodiak ended Q2 2026 with $125.9 million in cash and expects runway into 2027.