Kodiak's stock doubles with win for resurrected eye disease drug

Key Points:

• Kodiak Sciences’ two drug candidates, tarcocimab tedromer and tabirafusp alfa tedromer, matched the efficacy of Regeneron's Eylea (aflibercept) in a phase 3 trial for wet age-related macular degeneration (wAMD), positioning the company to seek FDA approval this year.
• The Daybreak study showed both candidates achieved comparable vision gains to aflibercept after one year, with tarcocimab demonstrating longer dosing intervals (up to 24 weeks) versus aflibercept’s eight-week schedule, aided by an AI-guided retreatment algorithm.
• Kodiak plans to file for FDA approval of tarcocimab (Zenkuda) in Q4, supported by data from five phase 3 trials covering wAMD, diabetic retinopathy, and retinal vein occlusion, despite a prior development pause due to cataract concerns which have since been addressed.
• Investors reacted positively to the results, driving Kodiak’s stock price up 128% to $72.99, though the competitive landscape includes lower-cost aflibercept biosimilars and branded rivals like Eylea HD and Roche’s Vabysmo.
• Kodiak’s release emphasized tarcocimab over tabirafusp, which also matched aflibercept on primary endpoints; further analyses and a phase 3 superiority trial are underway to explore tabirafusp’s benefits, particularly in diabetic macular edema.