KOD shares jumped as much as 90% in premarket trading after the company reported encouraging DAYBREAK data in wet age-related macular degeneration
Kodiak Sciences (KOD) shares surged as much as 90% in premarket trading Monday after the biotechnology company announced positive Phase 3 results for Zenkuda in patients with wet age-related macular degeneration.
The company said its DAYBREAK study met its primary endpoint, with Zenkuda producing vision gains and retinal drying while allowing 54% of patients to receive treatment on a six-month dosing schedule. Zenkuda achieved non-inferiority in vision gains compared with aflibercept after one year, with the study reporting a primary endpoint p-value of 0.0007.
Kodiak’s tabirafusp-ted also met its primary vision endpoint, with a p-value of 0.0036, as well as a key secondary anatomical endpoint.
Safety results were also closely watched. Zenkuda recorded no cases of intraocular inflammation and a 0.5% cataract adverse-event rate, compared with 0.9% for aflibercept. Tabirafusp-ted recorded a 0.4% intraocular inflammation rate and no cataract adverse events.
Following the results, Kodiak plans to submit a multi-indication biologics license application for Zenkuda in the fourth quarter of 2026.
The planned application is expected to incorporate five positive Phase 3 studies spanning wet AMD, diabetic retinopathy and retinal vein occlusion, potentially positioning Zenkuda as a significant new entrant in retinal disease treatment.
