Tarcocimab tedromer (KSI-501) - (DAYBREAK)

May 7, 2026: Kodiak Sciences Inc. (NASDAQ: KOD) reported business updates highlighting multiple upcoming late-stage ophthalmology catalysts and reiterated plans for a first multi-indication BLA.

Zenkuda (tarcocimab tedromer, anti-VEGF; ABC Platform): The company cited positive topline Phase 3 GLOW2 results in diabetic retinopathy (DR), showing superiority vs sham. ≥2-step DRSS improvement was 62.5% for Zenkuda vs 3.3% for sham (p<0.0001). Key secondary endpoints included an 85% risk reduction in sight-threatening complications (2.4% vs 15.8%; p=0.0001) and ≥3-step DRSS improvement (13.7% vs 0%; p<0.0001). Safety noted no intraocular inflammation/retinal vasculitis and 2% cataract AEs per arm. Kodiak stated Zenkuda now has a “multi-indication BLA-ready profile” based on GLOW1/GLOW2 (DR), BEACON (RVO) and DAYLIGHT (wet AMD).

DAYBREAK Phase 3 (wet AMD; Zenkuda and KSI-501 vs aflibercept): Enrollment completed (~690). Topline one-year primary endpoint data expected in September 2026 (3Q 2026).

KSI-101 (MESI): Phase 3 PEAK and PINNACLE enrolling; topline expected 4Q 2026 (PEAK) and 2Q 2027 (PINNACLE). Final Phase 1b APEX data were presented Feb 7, 2026 (Angiogenesis, Exudation and Degeneration meeting).