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Kodiak Sciences (KOD) Focuses on Developing Eye Candidate KSI-301
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Kodiak Sciences Inc. (KOD - Free Report) has made rapid progress in the development of its lead pipeline candidate, KSI-301, a biologic therapy for treating various retinal vascular diseases.
The company is conducting the pivotal phase IIb/III DAZZLE study on KSI-301 for the treatment of wet-age-related macular degeneration (wet AMD). Enrollment in the study is complete, with top-line data from the same expected in the first quarter of 2022.
In June 2021, the company started enrollment in a phase III study — DAYLIGHT — a short-interval study that will evaluate the safety and efficacy of high-frequency KSI-301 in patients with treatment-naïve wet AMD. Enrollment in this study is expected to be completed in the first half of 2022.
The phase III BEACON study is evaluating KSI-301 for treating macular edema due to retinal vein occlusion (“RVO”). Enrollment in the study is now complete, with top-line data from the same expected in mid-2022. This apart, two pivotal phase III studies, namely GLEAM and GLIMMER, are evaluating KSI-301 in patients with treatment-naïve diabetic macular edema (“DME”). Enrollment in the study is expected to be completed in the first quarter of 2022.
Kodiak Sciences remains on course to file a single biologics license application (“BLA”) for KSI-301 to treat wet AMD, DME and RVO. Data from all these studies are expected to be included in the initial BLA for KSI-301.
The company is also evaluating KSI-301 in the pivotal phase III GLOW study for treating patients with non-proliferative diabetic retinopathy without DME. However, the company does not intend to include this study data and indication in its initial BLA filing mentioned above.
Shares of Kodiak Sciences have plunged 40% so far this year compared with the industry’s decline of 21.2%.
Image Source: Zacks Investment Research
We note that Kodiak Sciences’ pipeline is in early- to mid-stage development and a few years away from commercialization. Also, with no approved product in its commercial portfolio, Kodiak Sciences lacks a source of generating regular income. Hence, failure in ongoing studies will hurt the stock.
Kodiak Sciences’ portfolio is devoid of collaboration contracts for product development/commercialization, which is a concern. In the absence of future collaboration partners in the United States and other countries, it might not be able to realize the full value of its products. Stiff competition from several big companies in the target market also remains a headwind.
Image: Shutterstock
Kodiak Sciences (KOD) Focuses on Developing Eye Candidate KSI-301
Kodiak Sciences Inc. (KOD - Free Report) has made rapid progress in the development of its lead pipeline candidate, KSI-301, a biologic therapy for treating various retinal vascular diseases.
The company is conducting the pivotal phase IIb/III DAZZLE study on KSI-301 for the treatment of wet-age-related macular degeneration (wet AMD). Enrollment in the study is complete, with top-line data from the same expected in the first quarter of 2022.
In June 2021, the company started enrollment in a phase III study — DAYLIGHT — a short-interval study that will evaluate the safety and efficacy of high-frequency KSI-301 in patients with treatment-naïve wet AMD. Enrollment in this study is expected to be completed in the first half of 2022.
The phase III BEACON study is evaluating KSI-301 for treating macular edema due to retinal vein occlusion (“RVO”). Enrollment in the study is now complete, with top-line data from the same expected in mid-2022. This apart, two pivotal phase III studies, namely GLEAM and GLIMMER, are evaluating KSI-301 in patients with treatment-naïve diabetic macular edema (“DME”). Enrollment in the study is expected to be completed in the first quarter of 2022.
Kodiak Sciences remains on course to file a single biologics license application (“BLA”) for KSI-301 to treat wet AMD, DME and RVO. Data from all these studies are expected to be included in the initial BLA for KSI-301.
The company is also evaluating KSI-301 in the pivotal phase III GLOW study for treating patients with non-proliferative diabetic retinopathy without DME. However, the company does not intend to include this study data and indication in its initial BLA filing mentioned above.
Shares of Kodiak Sciences have plunged 40% so far this year compared with the industry’s decline of 21.2%.
We note that Kodiak Sciences’ pipeline is in early- to mid-stage development and a few years away from commercialization. Also, with no approved product in its commercial portfolio, Kodiak Sciences lacks a source of generating regular income. Hence, failure in ongoing studies will hurt the stock.
Kodiak Sciences’ portfolio is devoid of collaboration contracts for product development/commercialization, which is a concern. In the absence of future collaboration partners in the United States and other countries, it might not be able to realize the full value of its products. Stiff competition from several big companies in the target market also remains a headwind.
Zacks Rank & Stocks to Consider
Kodiak Sciences currently carries a Zacks Rank #3 (Hold). Better-ranked stocks in the biotech sector include Sarepta Therapeutics, Inc. (SRPT - Free Report) , Kiniksa Pharmaceuticals, Ltd. (KNSA - Free Report) and vTv Therapeutics Inc. (VTVT - Free Report) , all carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Sarepta Therapeutics’ loss per share estimates have narrowed 28.2% for 2021 and 25.2% for 2022, over the past 60 days.
Earnings of Sarepta Therapeutics have surpassed estimates in two of the trailing four quarters, and missed the same on the other two occasions.
Kiniksa Pharmaceuticals’ loss per share estimates have narrowed 15.2% for 2021 and 18.4% for 2022, over the past 60 days.
Kiniksa Pharmaceuticals’ earnings have surpassed estimates in three of the trailing four quartersand missed the same on the other occasion.
vTv Therapeutics’ loss per share estimates have narrowed 21.7% for 2021 and 2.9% for 2022, over the past 60 days.
vTv Therapeutics’ earnings have surpassed estimates in three of the trailing four quarters and missed the same on the other occasion.