Kodiak Sciences announced that its investigational eye therapies, Zenkuda and KSI-501, met their primary endpoints of non-inferiority to Regeneron's Eylea in the Phase 3 DAYBREAK trial for wet age-related macular degeneration. Zenkuda demonstrated a six-month dosing interval in 54% of patients. Kodiak plans to submit a Biologics License Application for Zenkuda in the fourth quarter of 2026. Following the news on September 28, 2026, Kodiak's stock surged up to 166% in early trading.
Overview of the DAYBREAK trial
- ▪Kodiak Sciences' investigational therapies Zenkuda and KSI-501 met their primary endpoints of non-inferiority in vision gains compared to Regeneron's Eylea (aflibercept) at one year in the Phase 3 DAYBREAK trial.
- ▪Both Zenkuda and KSI-501 demonstrated favorable safety profiles in the Phase 3 DAYBREAK clinical trial for wet age-related macular degeneration.
- ▪The Phase 3 DAYBREAK clinical trial evaluated both Zenkuda and KSI-501 against a common control arm of aflibercept for the treatment of wet age-related macular degeneration.
Zenkuda results in DAYBREAK trial
- ▪Zenkuda demonstrated a 0% intraocular inflammation rate and a 0.5% cataract adverse event rate in the Phase 3 DAYBREAK trial, compared to a 0.9% inflammation rate for aflibercept.
- ▪In the Phase 3 DAYBREAK trial, Zenkuda met its primary endpoint of non-inferiority in vision gains compared to aflibercept with a p-value of 0.0007.
- ▪In the Phase 3 DAYBREAK trial, 54% of wet age-related macular degeneration patients treated with Zenkuda achieved a six-month dosing interval following an initial loading period.
KSI-501 results in DAYBREAK trial
- ▪In the Phase 3 DAYBREAK trial, KSI-501 met its primary vision endpoint with a p-value of 0.0036 and its secondary anatomical endpoint with a p-value of less than 0.0001.
- ▪Zenkuda demonstrated a 0% intraocular inflammation rate and a 0.5% cataract adverse event rate in the Phase 3 DAYBREAK trial, compared to a 0.9% inflammation rate for aflibercept.
Zenkuda design and dosing
- ▪Zenkuda is designed with a mean ocular half-life of 20 days, which is approximately three times longer than approved anti-VEGF therapies.
- ▪In the Phase 3 DAYBREAK trial, patients receiving Zenkuda were given individualized dosing every four to 24 weeks following four monthly loading doses based on a treat-to-dryness approach.
KSI-501 mechanism and development
- ▪Kodiak Sciences is evaluating KSI-501 in an ongoing Phase 3 pivotal program, known as the ALTO program, for the treatment of diabetic macular edema.
- ▪KSI-501 is an anti-IL-6 and VEGF-trap bispecific therapy built on Kodiak Sciences' antibody biopolymer conjugate platform that targets both abnormal blood vessel formation and inflammatory processes.
Regulatory outlook for Zenkuda
- ▪If approved by regulatory authorities, Zenkuda would represent the first marketed product for Kodiak Sciences.
- ▪The planned fourth-quarter 2026 Biologics License Application for Zenkuda will include data from five Phase 3 studies across wet age-related macular degeneration, diabetic retinopathy, and retinal vein occlusion.
- ▪Kodiak Sciences plans to submit a multi-indication Biologics License Application for Zenkuda to the FDA in the fourth quarter of 2026.
Impact on Kodiak Sciences stock
- ▪On Monday, September 28, 2026, Kodiak Sciences shares surged 65% to $54.42 during premarket hours and 166% to $86.53 about one hour into trading, following the DAYBREAK trial announcement.
- ▪The stock rally on September 28, 2026, occurred despite broader market declines, with the Nasdaq falling 1%, the S&P 500 falling 0.6%, and the Dow falling 0.5%.
Debatable claims
- ▪KSI-501's dual-target mechanism makes it a more promising therapy than single-target drugs
- ▪Zenkuda's longer dosing interval makes it superior to Eylea for wet AMD
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