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Kodiak (KOD) Treats First Patient in Diabetic Macular Edema Study

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KodiakSciences (KOD - Free Report) announced that the first patient has been treated in the early-stage study of investigational candidate, KSI-501, for the treatment of diabetic macular edema (DME).

KSI-501 is a bispecific antibody biopolymer conjugate designed to target vascular endothelial growth factor (VEGF) and interleukin-6 (IL-6).

The phase I study is an open-label, multiple ascending dose study currently conducted in the United States, with patients enrolled at the Retinal Consultants of Arizona in Phoenix. The primary objectives of the aforementioned study are to evaluate ocular and systemic safety, and establish a maximum tolerated dose.

Elevated levels of ocular IL-6 have been associated with poor anti-VEGF treatment response, making KSI-501 a potential new category of retinal medicine. It also strongly inhibits both VEGF-mediated vascular permeability and IL-6 mediated inflammation in a single bispecific molecule.

KSI-501 is the second product candidate built on Kodiak's Antibody Biopolymer Conjugate platform to enter the clinics.

Shares of Kodiak have plunged 27.9% in the past year compared with the industry's 15.2% decline.

 

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The same were up almost 22% in the previous week as the company announced better-than-expected fourth-quarter and 2022 results. The net loss for the fourth quarter was $1.35 per share, narrower than the Zacks Consensus Estimate of a loss of $1.58 per share. Kodiak had cash, cash equivalents and marketable securities worth $478.9 million as of December-end 2022.

The initiation of the phase I clinical study of KSI-501 represents a significant step toward developing treatments for retinal diseases, particularly DME, which has a high prevalence.

Kodiak's lead product candidate, tarcocimab tedromer (KSI-301), is currently being evaluated in several pivotal studies for addressing diabetic retinopathy, retinal vein occlusion, DME and non-proliferative diabetic retinopathy without DME.

Zacks Rank & Other Stocks to Consider

Currently, Kodiak Sciences has a Zacks Rank #2 (Buy).

Some other top-ranked stocks in the same sector are CRISPR Therapeutics (CRSP - Free Report) and Kala Pharmaceuticals (KALA - Free Report) . Both CRISPR Therapeutics and Kala Pharmaceuticals carry a Zacks Rank #2 at present. You can seethe complete list of today's Zacks #1 Rank (Strong Buy) stocks here.

Loss per share estimates for CRISPR have narrowed from $8.21 to $7.35 for 2023 in the past 60 days.

CRSP's earnings beat estimates in two of the last four quarters and missed the mark in the other two, the average surprise being 3.19%. The company’s shares have plunged 34.8% in the past year.

Loss per share estimates for Kala have narrowed from $19.67 to $15.35 for 2023 and from $14.41 to $13.12 for 2024 in the past 60 days. The company’s shares have plunged 77.4% in the past year.

KALA’s earnings beat estimates in two of the last four quarters and missed the mark in the other two, the average surprise being 11.56%.

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