Shares of Kodiak Sciences Inc. KOD have rallied 63% in the past three months against the industry’s decrease of 1.5%.
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The company has made rapid good progress during this period with the development of its lead pipeline candidate, tarcocimab tedromer (formerly KSI-301, also known as tarcocimab), for treating various retinal vascular diseases.
KOD is evaluating tarcocimab in the phase III DAYLIGHT study for the treatment of patients with treatment-naïve wet age-related macular degeneration (wet AMD). Top-line data from the study is expected in mid-2023.
Apart from this, the phase III BEACON study is evaluating tarcocimab in patients with treatment-naïve retinal vein occlusion (RVO).
In August 2022, the BEACON study met the primary endpoint of non-inferior change from baseline in visual acuity at week 24 for subjects dosed with tarcocimab versus Eylea (aflibercept) in patients with macular edema due to RVO. Tarcocimab was generally safe and well tolerated in the study.
Eylea is an anti-VEGF treatment developed by Regeneron REGN in collaboration with Bayer’s BAYRY HealthCare unit.
Regeneron/Bayer’s Eylea has been approved by the FDA for multiple retinal indications, including DME, wet AMD and RVO.
While REGN records net product sales of Eylea in the United States, BAYRY records net product sales of Eylea outside the country.
This apart, two phase III studies — GLEAM and GLIMMER —are evaluating tarcocimab for treating patients with diabetic macular edema ("DME").
The GLEAM and GLIMMER studies are designed to evaluate the durability, efficacy and safety of tarcocimab in treatment-naïve patients with DME. Top-line data from the same is expected in mid-2023.
Kodiak Sciences is also evaluating tarcocimab in the pivotal phase III GLOW study for treating patients with non-proliferative diabetic retinopathy without DME. Enrollment in this study is now complete, with the top-line data expected in the second half of 2023.
The company remains on course to file a single biologics license application (“BLA”) for tarcocimab to treat wet AMD, DME, DR and RVO. Data from all these studies are expected to be included in the initial BLA for tarcocimab.
Tarcocimab is being developed as a new first-line agent to improve outcomes for patients with retinal vascular diseases.
Kodiak Sciences currently has no approved product in its commercial portfolio, hence the company lacks a source for generating regular income. Failure in ongoing studies will hurt the stock.
Kodiak Sciences Inc. Price
Kodiak Sciences Inc. price | Kodiak Sciences Inc. Quote
Zacks Rank & Stock to Consider
Kodiak Sciences currently carries a Zacks Rank #3 (Hold). A better-ranked stock in the biotech sector is Achilles Therapeutics plc ACHL, which has a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Achilles Therapeutics’ loss per share estimates narrowed 6.4% for 2022 and 9.6% for 2023 in the past 60 days.
Earnings of Achilles Therapeutics surpassed estimates in three of the trailing four quarters and missed on the remaining occasion. ACHL delivered an earnings surprise of 12.45%, on average.
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