Investing.com — Shares of Kodiak Sciences Inc (NASDAQ:KOD) surged 90% in premarket trading Monday following positive results from its Phase 3 DAYBREAK study in wet age-related macular degeneration.
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The company’s drug Zenkuda met its primary endpoint with a p-value of 0.0007, demonstrating vision gains and retinal drying in 54% of patients on treatment for 6 months. The drug achieved non-inferiority in vision gains compared to aflibercept within the first year. Tabirafusp-ted also met its primary endpoint of vision with a p-value of 0.0036 and its key anatomical secondary endpoint in the same study.
Kodiak plans to submit a multi-indication biologics license application for Zenkuda in the fourth quarter of 2026, including five positive Phase 3 studies in wet AMD, diabetic retinopathy and retinal vein occlusion.
In the DAYBREAK study, Zenkuda demonstrated a clinical effect matching or exceeding aflibercept throughout the loading phase. The drug showed a 0% rate of intraocular inflammation and a 0.5% rate of cataract-related adverse events, compared to 0.9% with aflibercept. Tabirafusp-ted showed an intraocular inflammation rate of 0.4% and a cataract adverse event rate of 0%.
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The DAYBREAK study evaluated both drugs against aflibercept as an active comparator. Patients receiving Zenkuda received an individualized dose every 4 to 24 weeks after four monthly loading doses, using a dryness treatment approach based on the presence of retinal fluid.
Kodiak also plans to report Phase 3 results from its first study in macular edema secondary to KSI-101 inflammation in December 2026. The company is advancing tabirafusp treatment in diabetic macular edema through its ongoing pivotal Phase 3 ALTO program.
Both Zenkuda and tabirafusp-ted are built on Kodiak’s antibody biopolymer conjugate platform. Zenkuda has an average ocular half-life of approximately 20 days, approximately three times longer than approved anti-VEGF therapies.
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Original article
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