Kodiak Sciences KOD announced that it has completed enrollment in a late-stage study of tarcocimab tedromer in patients with diabetic retinopathy (“DR”). Per KOD, more than 250 patients have been enrolled in the phase III GLOW2 study, surpassing the initial enrollment target. With a 48-week treatment duration, all patients are expected to complete their primary endpoint visits by the end of January 2026. The top-line clinical data is anticipated to be announced in the first quarter of 2026.
In late 2023, Kodiak rebooted the development program of tarcocimab following positive phase III results from the GLOW1 study, which evaluated the treatment in patients with moderately severe to severe non-proliferative diabetic retinopathy. Leveraging the GLOW1 study's success, Kodiak initiated the GLOW2 study to further investigate tarcocimab for DR and began dosing patients in May 2024. Enrolled DR patients will receive tarcocimab on extended dosing intervals, including six-month dosing for all patients.
KOD’s Other Pipeline Programs Progressing Well
Kodiak is also developing KSI-501, a dual inhibitor bioconjugate molecule, to address inflammation and abnormal blood vessel growth in retinal vascular diseases. Following a successful phase I study, Kodiak has advanced KSI-501 into phase III through the DAYBREAK study, which will assess its efficacy, durability and safety for wet age-related macular degeneration (wet AMD). KOD is also studying tarcocimab as a second investigational arm in the DAYBREAK study for wet AMD, with KSI-501 being the first investigational arm.
This is designed to be a non-inferiority study evaluating KSI-501 dosed every four to 24 weeks compared with Regeneron’s Eylea dosed per label. The phase III DAYBREAK study on tarcocimab and KSI-501 is also currently enrolling patients. By initiating a second phase III study, Kodiak is positioning itself with two late-stage candidates, providing a potential fallback if one program encounters challenges.
In the past three months, Kodiak shares have plunged 55.6% against the industry’s 2.2% growth.
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The top-line data from the DAYBREAK study is expected in the second quarter of 2026. Kodiak plans to leverage potentially successful data readout from both the GLOW2 and DAYBREAK studies to file a single regulatory application for tarcocimab, seeking its approval for the treatment of wet AMD, DR and retinal vein occlusion (“RVO”). Please note that the company had earlier reported the success of its phase III BEACON study evaluating tarcocimab for RVO.
Additionally, Kodiak is developing the unconjugated protein component of KSI-501, known as KSI-101 (formerly known as KSI-501P), for patients with diabetic macular edema (“DME”) and macular edema secondary to inflammation (“MESI”). It is a novel, potent and high-strength bispecific protein targeting IL-6 and VEGF. At present, there are no available intravitreal biologic therapies addressing the spectrum of inflammatory conditions of the retina, which represents a huge new market opportunity separate from the established anti-VEGF market.
Kodiak is enrolling patients in the phase Ib APEX study, evaluating KSI-101 in two new cohorts, cohort 1 in patients with DME and cohort 2 in patients with MESI. The APEX study will evaluate the safety and tolerability, and identify two dose levels of KSI-101 to progress into late-stage development. The pivotal phase IIb/III studies (PEAK and PINNACLE) will investigate KSI-101 in MESI.
Kodiak Sciences Inc. Price and Consensus
Kodiak Sciences Inc. Price and Consensus
Kodiak Sciences Inc. price-consensus-chart | Kodiak Sciences Inc. Quote
KOD’s Zacks Rank and Stocks to Consider
Kodiak currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks from the sector are Gilead Sciences GILD, BioMarin Pharmaceutical BMRN and Corcept Therapeutics CORT, each carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
In the past 30 days, estimates for Gilead Sciences’ 2025 earnings have improved from $7.60 to $7.87 per share. During the same timeframe, the estimate for earnings per share for 2026 has improved from $7.92 to $8.27. In the past three months, shares of Gilead Sciences have gained 26.9%.
GILD’s earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 19.47%.
In the past 30 days, the estimate for BioMarin Pharmaceutical’s 2025 earnings per share has increased from $4 to $4.24. The estimates for 2026 earnings per share has increased from $5.16 to $5.25 during the same timeframe. In the past three months, BioMarin Pharmaceutical shares have gained 8.7%.
BMRN’s earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 32.36%.
In the past 30 days, the estimate for Corcept Therapeutics’ 2025 earnings per share has increased from $1.66 to $1.84. The estimate for 2026 earnings per share has increased from $2.86 to $3.05. In the past three months, shares of Corcept Therapeutics have gained 0.1%.
CORT’s earnings beat estimates in three of the trailing four quarters and missed once, delivering an average surprise of 20.08%.
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