Kodiak Sciences Stock Doubles as Zenkuda Matches Eylea in Phase 3 Trial

3 min read
Source: fiercebiotech.com
Kodiak Sciences Stock Doubles as Zenkuda Matches Eylea in Phase 3 Trial
Photo: fiercebiotech.com
TL;DR

Kodiak Sciences shares surged 128% after its Phase 3 trial showed its eye drug Zenkuda matched the efficacy of Regeneron’s Eylea for wet age-related macular degeneration. The company plans to file for FDA approval in the fourth quarter of 2026, leveraging an AI-guided dosing strategy that allows longer intervals between injections.

Key points

  • Kodiak Sciences stock rose from $32.35 to $72.99, adding over $3 billion to its market value.
  • Zenkuda and tabirafusp alfa tedromer both matched aflibercept (Eylea) on primary vision endpoints in the Daybreak trial.
  • An AI-guided algorithm allowed 54% of Zenkuda patients to receive injections every 24 weeks, compared to every 8 weeks for Eylea.
  • Kodiak plans to file for FDA approval of Zenkuda in Q4 2026, covering wet AMD, diabetic retinopathy, and retinal vein occlusion.
  • The company faces competition from biosimilars and branded rivals like Eylea HD and Vabysmo.

Background

Kodiak previously halted Zenkuda development in 2023 due to an unexpected increase in cataracts but resumed trials later that year based on non-proliferative diabetic retinopathy data. This recent success marks a significant turnaround for the biotech, which had failed to match Eylea in a trial more than four years ago. The broader market context includes a growing aging population with eye disorders and a trend toward drugs that extend dosing intervals to reduce patient burden.

How outlets are covering it

Fierce Biotech and BioPharma Dive both highlight the stock surge and the non-inferiority of Zenkuda and tabirafusp to Eylea. Fierce Biotech emphasizes the competitive landscape, noting that expired patents on aflibercept allow biosimilars like Biocon’s Yesafili to compete, alongside branded rivals such as Roche’s Vabysmo. BioPharma Dive focuses on the clinical mechanics, detailing how the AI-guided dosing strategy enabled 54% of patients to extend injection intervals to six months. Both sources agree on the positive safety profile, including a numerically lower rate of cataracts for Zenkuda compared to aflibercept, though Fierce Biotech notes that detailed data comparing the two drugs has not yet been fully shared.

Why it matters

This success positions Kodiak to challenge the dominant market share of Eylea in treating wet age-related macular degeneration. The ability to extend dosing intervals could significantly reduce the burden on ophthalmologists and patients, potentially capturing a large share of the growing eye disease market. However, the company must navigate intense competition from biosimilars and newer branded therapies that also offer extended dosing schedules.

What to watch

Kodiak plans to file for FDA approval of Zenkuda in the fourth quarter of 2026. The company will also conduct post-hoc analyses to identify patient subgroups that benefit from IL-6 inhibition via tabirafusp alfa tedromer. A Phase 3 superiority trial comparing tabirafusp to aflibercept in diabetic macular edema is ongoing, with approval expected for this drug late next year.

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