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KOD Stock Soars 178% on Positive Wet AMD Data as BLA Filing Nears
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Key Takeaways
Kodiak's Zenkuda and tabirafusp-ted met primary vision endpoints in the phase III DAYBREAK study.
Zenkuda showed sustained retinal drying, with 54% of patients reaching a six-month dosing interval.
Kodiak plans a multi-indication Zenkuda BLA submission in the fourth quarter of 2026.
Shares of Kodiak Sciences (KOD - Free Report) have surged 178% following the announcement of positive top-line data from the phase III DAYBREAK study on its key pipeline candidate, Zenkuda (tarcocimab tedromer).
The study evaluated Zenkuda and tabirafusp-ted (formerly known as KSI-501), Kodiak’s second clinical candidate in parallel investigational arms, with the results compared with Regeneron’s (REGN - Free Report) Eylea (aflibercept) for the treatment of patients with wet age-related macular degeneration (wAMD). Eylea is Regeneron’s established therapy for wAMD.
Zenkuda is a novel anti-VEGF antibody biopolymer conjugate (ABC) under development for the treatment of retinal vascular diseases, while tabirafusp-ted is a first-in-class anti-IL-6, VEGF-trap bispecific therapy built on the ABC platform.
wAMD is an eye disease in which abnormal blood vessels grow under the retina and leak fluid or blood, causing rapid central vision loss.
Year to date, shares of Kodiak have skyrocketed 221.6% compared with the industry’s 8.3% growth.
Image Source: Zacks Investment Research
Key Details of KOD’s Phase III DAYBREAK Study Data
The DAYBREAK study met its primary endpoint across both arms.
The data showed that Zenkuda was non-inferior to Regeneron’s Eylea in improving vision at one year. It also showed rapid disease control during the loading phase and sustained retinal drying. Notably, 54% of patients reached a six-month dosing interval at one year, despite strict retreatment criteria, thus demonstrating strong durability of clinical effects. Zenkuda was generally well-tolerated, with 0% intraocular inflammation and a 0.5% cataract adverse-event rate compared with 0.9% for Eylea. The safety profile was consistent with the established profile of Eylea.
The dosing durability could reduce the frequency of injections for many patients if the drug is approved.
The positive DAYBREAK results strengthen Kodiak’s broader phase III program for Zenkuda. The company plans to submit a multi-indication biologics license application in the fourth quarter of 2026, supported by positive results from five phase III studies across three retinal vascular conditions. The filing is expected to include DAYBREAK and DAYLIGHT in wet AMD, GLOW and GLOW2 in diabetic retinopathy, and BEACON in macular edema following retinal vein occlusion. If approved, Zenkuda could become Kodiak’s first commercial product, marking an important step toward commercialization.
Tabirafusp-ted Meets Key Endpoints
Like Zenkuda, Tabirafusp-ted met the primary vision endpoint, demonstrating non-inferiority to Eylea in vision gains. It also achieved the anatomical key secondary endpoint. The candidate was generally well-tolerated, with 0.4% intraocular inflammation and no reported cataract adverse events.
Following the positive DAYBREAK study data, Kodiak plans to conduct post-hoc analyses to identify treatment-naïve wAMD patient subgroups that may benefit from IL-6 inhibition, the mechanism targeted by tabirafusp-ted. The company is advancing the candidate in diabetic macular edema, a retinal condition associated with inflammation. The candidate is being evaluated in the ongoing phase III ALTO study.
KOD’s Zacks Rank & Stock to Consider
Kodiak Sciences currently carries a Zacks Rank #4 (Sell).
Over the past 60 days, estimates for Precigen’s 2026 bottom line have improved from a loss of 2 cents to earnings per share of 24 cents. Over the same period, earnings estimates for 2027 have risen from 25 cents to 73 cents. PGEN shares have gained 86.9% year to date.
Precigen’s earnings beat estimates in three of the trailing four quarters and missed in the remaining one, with the average surprise being 108.96%.
Over the past 60 days, estimates for AC Immune’s 2026 loss per share have narrowed from 84 cents to 60 cents. Over the same period, earnings estimates for 2027 remained unchanged at 17 cents per share. ACIU shares have lost 16.9% year to date.
AC Immune’s earnings beat estimates in each of the trailing four quarters, with the average surprise being 33.25%.
View the Zacks #1 Rank List
Image: Bigstock
KOD Stock Soars 178% on Positive Wet AMD Data as BLA Filing Nears
Key Takeaways
Shares of Kodiak Sciences (KOD - Free Report) have surged 178% following the announcement of positive top-line data from the phase III DAYBREAK study on its key pipeline candidate, Zenkuda (tarcocimab tedromer).
The study evaluated Zenkuda and tabirafusp-ted (formerly known as KSI-501), Kodiak’s second clinical candidate in parallel investigational arms, with the results compared with Regeneron’s (REGN - Free Report) Eylea (aflibercept) for the treatment of patients with wet age-related macular degeneration (wAMD). Eylea is Regeneron’s established therapy for wAMD.
Zenkuda is a novel anti-VEGF antibody biopolymer conjugate (ABC) under development for the treatment of retinal vascular diseases, while tabirafusp-ted is a first-in-class anti-IL-6, VEGF-trap bispecific therapy built on the ABC platform.
wAMD is an eye disease in which abnormal blood vessels grow under the retina and leak fluid or blood, causing rapid central vision loss.
Year to date, shares of Kodiak have skyrocketed 221.6% compared with the industry’s 8.3% growth.
Image Source: Zacks Investment Research
Key Details of KOD’s Phase III DAYBREAK Study Data
The DAYBREAK study met its primary endpoint across both arms.
The data showed that Zenkuda was non-inferior to Regeneron’s Eylea in improving vision at one year. It also showed rapid disease control during the loading phase and sustained retinal drying. Notably, 54% of patients reached a six-month dosing interval at one year, despite strict retreatment criteria, thus demonstrating strong durability of clinical effects. Zenkuda was generally well-tolerated, with 0% intraocular inflammation and a 0.5% cataract adverse-event rate compared with 0.9% for Eylea. The safety profile was consistent with the established profile of Eylea.
The dosing durability could reduce the frequency of injections for many patients if the drug is approved.
The positive DAYBREAK results strengthen Kodiak’s broader phase III program for Zenkuda. The company plans to submit a multi-indication biologics license application in the fourth quarter of 2026, supported by positive results from five phase III studies across three retinal vascular conditions. The filing is expected to include DAYBREAK and DAYLIGHT in wet AMD, GLOW and GLOW2 in diabetic retinopathy, and BEACON in macular edema following retinal vein occlusion. If approved, Zenkuda could become Kodiak’s first commercial product, marking an important step toward commercialization.
Tabirafusp-ted Meets Key Endpoints
Like Zenkuda, Tabirafusp-ted met the primary vision endpoint, demonstrating non-inferiority to Eylea in vision gains. It also achieved the anatomical key secondary endpoint. The candidate was generally well-tolerated, with 0.4% intraocular inflammation and no reported cataract adverse events.
Following the positive DAYBREAK study data, Kodiak plans to conduct post-hoc analyses to identify treatment-naïve wAMD patient subgroups that may benefit from IL-6 inhibition, the mechanism targeted by tabirafusp-ted. The company is advancing the candidate in diabetic macular edema, a retinal condition associated with inflammation. The candidate is being evaluated in the ongoing phase III ALTO study.
KOD’s Zacks Rank & Stock to Consider
Kodiak Sciences currently carries a Zacks Rank #4 (Sell).
Some better-ranked stocks in the biotech sector are Precigen (PGEN - Free Report) , currently sporting a Zacks Rank #1 (Strong Buy), and AC Immune (ACIU - Free Report) , carrying a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Over the past 60 days, estimates for Precigen’s 2026 bottom line have improved from a loss of 2 cents to earnings per share of 24 cents. Over the same period, earnings estimates for 2027 have risen from 25 cents to 73 cents. PGEN shares have gained 86.9% year to date.
Precigen’s earnings beat estimates in three of the trailing four quarters and missed in the remaining one, with the average surprise being 108.96%.
Over the past 60 days, estimates for AC Immune’s 2026 loss per share have narrowed from 84 cents to 60 cents. Over the same period, earnings estimates for 2027 remained unchanged at 17 cents per share. ACIU shares have lost 16.9% year to date.
AC Immune’s earnings beat estimates in each of the trailing four quarters, with the average surprise being 33.25%.