Kodiak Sciences’ stock has soared by upwards of 90% after securing a duo of late-stage wins for its ophthalmology candidates, Zenkuda (tarcocimab tedromer) and tabirafusp-ted, in wet age-related macular degeneration (wAMD) – leading the company to tee up a potential approval for the former drug.
During the triple-arm Phase III DAYBREAK study (NCT06556368), Kodiak pitted its late-stage candidates, Zenkuda and tabirafusp-ted against Bayer and Regeneron’s commonly prescribed therapy, Eylea (aflibercept) in patients with neovascular wAMD. The trial primarily looked at whether each intravitreally administered experimental drug could improve treated patients’ sharpness and clarity of vision over Eylea.
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In this study, the California-based biotech found that both Zenkuda and tabirafusp-ted offered non-inferior improvements in visual acuity at the one-year mark – meeting the trial’s primary endpoint. Zenkuda also offered therapeutic impact over an extended period of time, with 54% of treated patients achieving six-month treatment durability at one year.
On top of their promising efficacy, patients also tolerated both drugs well, with no patients experiencing intraocular inflammation after treatment with Zenkuda, and only 0.5% of patients experiencing cataracts, versus 0.9% in the Eylea treatment arm.
Kodiak eyes Zenkuda approval in ophthalmic indications
Following this positive outcome, Kodiak is setting the wheels in motion to submit data for Zenkuda to regulatory authorities, with plans to achieve this in the final quarter of 2026. On top of the DAYBREAK results, Kodiak will also share data from the successful GLOW and BEACON programmes in diabetic retinopathy and macular oedema following retinal vein occlusion (RVO), as it eyes the drug’s potential debut on the market for several degenerative eye conditions.
The DAYBREAK result marks a positive step forward for patients with wAMD, who faced a setback following the failure of EyePoint’s Duravyu’s (vorolanib intravitreal insert) to best Eylea in August.
The results appear to have caught the eye of investors too, as Kodiak’s stock value shot up 89% from $32.35 at market close on 25 September to $61.28 at opening on 28 September on the Nasdaq. Since then, the biotech’s stock value has continued to increase, oscillating at between 150% to 160% up as of 10.30am ET.
Currently, there are between 10 and 20 million adults living with wAMD globally. The condition causes rapid loss of central vision due to the buildup of fluid in the eye caused by the leakage of abnormal blood vessels. While there are treatment options for wAMD, patients continue to face unmet needs, as a notable proportion of patients do not respond sufficiently and durably to current therapies such as Eylea and Roche’s Vabysmo (faricimab).
According to a report from GlobalData, parent company of Clinical Trials Arena, the AMD market is set for strong growth in the next few years, with analysts predicting that the segment’s value will rise from $8.9bn in 2024 to $24.1bn in 2034.
