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