Kodiak Sciences (NASDAQ:KOD) Inc. KOD announced that it has completed enrollment in the pivotal phase IIb/III DAZZLE study, which is evaluating its lead pipeline candidate KSI-301 for the treatment of patients with neovascular wet age-related macular degeneration (wet AMD).
The randomized DAZZLE study evaluated the efficacy, durability and safety of KSI-301 in the given patient population and enrolled more than 550 patients worldwide, surpassing the enrollment target. The study has a one-year primary efficacy endpoint and the top-line data from the same is expected in early 2022.
Shares of Kodiak Sciences have rallied 57.9% so far this year compared with the industry’s increase of 0.5%.
We note that KSI-301, an investigational anti-VEGF therapy built on Kodiak Sciences' proprietary antibody biopolymer conjugate (ABC) platform, is being developed for treating various neovascular retinal vascular diseases.
In the third quarter of 2020, Kodiak Sciences treated the first patient in the two pivotal phase III studies of GLEAM and GLIMMER, which is investigating KSI-301 for treating diabetic macular edema (DME). Another phase III BEACON study is evaluating KSI-301 for addressing macular edema due to retinal vein occlusion (RVO).
These studies along with the DAZZLE pivotal study are likely to form the basis of the biologics license applications (BLA) for KSI-301 to support its potential approval and commercialization.
Kodiak Sciences remains on course to file a single BLA for KSI-301 in 2022 to treat wet AMD, DME and RVO.
Further, the company plans to initiate an additional phase III GLOW study in early 2021 to investigate KSI-301 for treating patients with non-proliferative diabetic retinopathy without DME.
Zacks Rank & Stocks to Consider
Kodiak Sciences currently carries a Zacks Rank #4 (Sell).
Better-ranked stocks in the biotech sector include Abeona Therapeutics (NASDAQ:ABEO) Inc. ABEO, Halozyme (NASDAQ:HALO) Therapeutics, Inc. HALO and Cara Therapeutics (NASDAQ:CARA), Inc. CARA, 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.
Abeona Therapeutics’ loss per share estimates have narrowed 9.3% for 2020 and 9.8% for 2021 over the past 60 days.
Halozyme’s earnings estimates have been revised 19.7% and 16.6% upward for 2020 and 2021 each over the past 60 days. The stock has rallied 119.1% year to date.
Cara Therapeutics’ loss per share estimates have narrowed 14.2% for 2020 and 22.5% for 2021 over the past 60 days.
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