Kodiak’s retinal disease drug matches Eylea in Phase 3 trial; shares surge 128%

Kodiak Sciences’ retinal disease drug candidate showed efficacy comparable to Eylea in a Phase 3 clinical trial, sending the company’s shares up 128%.

According to U.S. biotech news outlet Fierce Biotech on the 28th (local time), Kodiak Sciences said tarcocimab and tavapufusp showed vision improvement comparable to Eylea in the DAYBREAK Phase 3 trial in patients with wet age-related macular degeneration (wAMD).

Eylea is a vascular endothelial growth factor (VEGF) inhibitor marketed by Regeneron. Both candidates recorded results comparable to Eylea on the primary endpoint, which assessed vision improvement after 1 year of treatment.

Following the news, Kodiak shares surged to $72.99 early in the trading session. That was 128% above the previous session’s closing price of $32.35.

Kodiak plans to seek U.S. Food and Drug Administration (FDA) approval for the anti-VEGF drug tarcocimab (brand name Zenkuda) in the fourth quarter of this year. The application will include results from 5 Phase 3 trials in wAMD, diabetic retinopathy and retinal vein occlusion.

Charles Wykoff, a retinal specialist at Houston Methodist Hospital, said, “The Zenkuda results exceeded expectations,” adding that they “meaningfully extended treatment intervals for most patients while maintaining optimal fluid control.”

Kodiak used an artificial intelligence (AI)-based retreatment algorithm to determine the dosing interval for tarcocimab. More than half of patients maintained dosing every 24 weeks for 1 year, while the Eylea group received treatment every 8 weeks.

The company has not yet released detailed data on tarcocimab but said its safety profile was also favorable, including a numerically lower incidence of cataracts than with Eylea.

Development of tarcocimab was temporarily halted in 2023 because of an increase in cataract incidence, then resumed that year based on data in nonproliferative diabetic retinopathy.

However, with Eylea’s patent expired, Kodiak will have to compete with lower-cost products such as Biocon’s biosimilar Yesafili. It will also face competition from branded drugs such as Regeneron’s Eylea HD and Roche’s Vabysmo.

Kodiak focused on tarcocimab in this announcement, but tavapufusp also showed results comparable to Eylea on the primary endpoint. The company plans to use future post hoc analyses to identify patient groups that may benefit from interleukin-6 (IL-6) inhibition.