We use cookies to understand how you use our site and to improve your experience. This includes personalizing content and advertising. To learn more, click here. By continuing to use our site, you accept our use of cookies, revised Privacy Policy and Terms of Service.
You are being directed to ZacksTrade, a division of LBMZ Securities and licensed broker-dealer. ZacksTrade and Zacks.com are separate companies. The web link between the two companies is not a solicitation or offer to invest in a particular security or type of security. ZacksTrade does not endorse or adopt any particular investment strategy, any analyst opinion/rating/report or any approach to evaluating individual securities.
If you wish to go to ZacksTrade, click OK. If you do not, click Cancel.
Kodiak (KOD) Counts on Tarcocimab Program Despite Setbacks
Read MoreHide Full Article
Kodiak Sciences Inc. (KOD - Free Report) is a clinical-stage biopharmaceutical company engaged in developing novel therapeutics to treat chronic and high-prevalence retinal diseases, which are the major causes of blindness. The company’s proprietary antibody biopolymer conjugate platform is designed to maintain potent and effective drug levels in ocular tissues for longer periods than the currently marketed biologic medicines for treating retinal diseases.
The company currently has no marketed drug in its portfolio.
It is developing its lead investigational candidate, tarcocimab, a novel anti-VEGF antibody biopolymer conjugate, for the treatment of retinal vascular diseases. Such diseases include diabetic eye disease and wet age-related macular degeneration (wet AMD).
In late 2023, Kodiak decided to reboot its tarcocimab development program after witnessing positive top-line results from its phase III GLOW1 study evaluating the same in moderately severe to severe non-proliferative diabetic retinopathy (NPDR).
In 2023, the company faced a major developmental setback that led to the abandonment of the development program of its lead candidate, tarcocimab, in the treatment of retinal vascular diseases. The decision was based on the failure of KOD’s late-stage GLEAM and GLIMMER studies, which could not meet the primary efficacy endpoints of showing non-inferior visual acuity gains for tarcocimab compared with Regeneron’s (REGN - Free Report) Eylea (aflibercept) in the treatment of diabetic macular edema (DME). Additionally, an unexpected increase in cataracts was observed over time in the tarcocimab arms of both studies.
Year to date, shares of Kodiak have soared 40.5% compared with the industry’s 1.5% growth.
Image Source: Zacks Investment Research
The company had previously reported the success of its phase III DAYLIGHT and BEACON studies evaluating tarcocimab in patients with wet AMD and retinal vein occlusion (RVO), respectively.
Thus, the positive data readouts from DAYLIGHT, BEACON and GLOW studies give Kodiak three successful phase III pivotal studies with tarcocimab tedromer across three different retinal vascular and exudative diseases, such as wet AMD, RVO and NPDR.
Based on feedback from the FDA, along with the success of the GLOW1 study, KOD initiated the pivotal phase III GLOW2 study evaluating tarcocimab in diabetic retinopathy during the fourth quarter of 2023. The success of the GLOW2 study is expected to serve as the basis for a regulatory filing for tarcocimab for all three indications, such as wet AMD, RVO and NPDR, seeking its approval.
The company is also currently gearing up to advance its second clinical candidate, KSI-501, a dual inhibitor Trap-Antibody-Fusion bioconjugate molecule, into a phase III DAYBREAK study to evaluate its efficacy, durability and safety in wet AMD later in 2024.
Kodiak plans to study tarcocimab as a second investigational arm in the DAYBREAK study in wet AMD, with KSI-501 being the first investigational arm.
The DAYBREAK study is designed to compare KSI-501 and tarcocimab head-to-head with Regeneron’s Eylea. Pending discussion with the FDA, the company plans to initiate the DAYBREAK study as soon as regulatory alignment is completed, i.e., by mid-2024.
The initiation of a second phase III study will give Kodiak two late-stage candidates, which is expected to provide some sort of a cushion to the company in terms of a fallback option in case one of the programs faces a setback.
KOD is simultaneously planning to initiate an early-stage study of the unconjugated protein portion of KSI-501, KSI-101 (formerly known as KSI-501P), for patients who have retinal fluid and inflammation.
Despite the encouraging developmental updates of pipeline candidates, clinical studies involve a high degree of risk, being prone to setbacks. The developmental timeline of tarcocimab has already been delayed significantly.
The company’s other developmental candidate, KSI-501, has yet to begin late-stage clinical development and is years away from commercialization. Possible setbacks in any of the two developmental programs will further hurt the stock. Kodiak’s portfolio is also devoid of collaboration contracts for product development/commercialization, which remains a concern.
Regeneron’s Eylea is one of its key growth drivers, which is being already approved for wet AMD, DME, RVO and diabetic retinopathy in the United States.The FDA has also approved Eylea to treat preterm infants with retinopathy of prematurity as well.
Please note that Bayer’s (BAYRY - Free Report) HealthCare unit co-develops Eylea with Regeneron. REGN records net product sales of Eylea in the United States. Bayer records net product sales of Eylea outside the United States. Regeneron records its share of profits/losses in connection with sales of Eylea outside the United States.
In the past 30 days, the Zacks Consensus Estimate for ADMA Biologics’ 2024 earnings per share (EPS) has remained constant at 30 cents. During the same period, the estimate for ADMA’s 2025 EPS has remained constant at 50 cents. Year to date, shares of ADMA have soared 40.3%.
ADMA beat estimates in three of the trailing four quarters and matched in one, delivering an average earnings surprise of 85%.
See More Zacks Research for These Tickers
Normally $25 each - click below to receive one report FREE:
Image: Bigstock
Kodiak (KOD) Counts on Tarcocimab Program Despite Setbacks
Kodiak Sciences Inc. (KOD - Free Report) is a clinical-stage biopharmaceutical company engaged in developing novel therapeutics to treat chronic and high-prevalence retinal diseases, which are the major causes of blindness. The company’s proprietary antibody biopolymer conjugate platform is designed to maintain potent and effective drug levels in ocular tissues for longer periods than the currently marketed biologic medicines for treating retinal diseases.
The company currently has no marketed drug in its portfolio.
It is developing its lead investigational candidate, tarcocimab, a novel anti-VEGF antibody biopolymer conjugate, for the treatment of retinal vascular diseases. Such diseases include diabetic eye disease and wet age-related macular degeneration (wet AMD).
In late 2023, Kodiak decided to reboot its tarcocimab development program after witnessing positive top-line results from its phase III GLOW1 study evaluating the same in moderately severe to severe non-proliferative diabetic retinopathy (NPDR).
In 2023, the company faced a major developmental setback that led to the abandonment of the development program of its lead candidate, tarcocimab, in the treatment of retinal vascular diseases. The decision was based on the failure of KOD’s late-stage GLEAM and GLIMMER studies, which could not meet the primary efficacy endpoints of showing non-inferior visual acuity gains for tarcocimab compared with Regeneron’s (REGN - Free Report) Eylea (aflibercept) in the treatment of diabetic macular edema (DME). Additionally, an unexpected increase in cataracts was observed over time in the tarcocimab arms of both studies.
Year to date, shares of Kodiak have soared 40.5% compared with the industry’s 1.5% growth.
Image Source: Zacks Investment Research
The company had previously reported the success of its phase III DAYLIGHT and BEACON studies evaluating tarcocimab in patients with wet AMD and retinal vein occlusion (RVO), respectively.
Thus, the positive data readouts from DAYLIGHT, BEACON and GLOW studies give Kodiak three successful phase III pivotal studies with tarcocimab tedromer across three different retinal vascular and exudative diseases, such as wet AMD, RVO and NPDR.
Based on feedback from the FDA, along with the success of the GLOW1 study, KOD initiated the pivotal phase III GLOW2 study evaluating tarcocimab in diabetic retinopathy during the fourth quarter of 2023. The success of the GLOW2 study is expected to serve as the basis for a regulatory filing for tarcocimab for all three indications, such as wet AMD, RVO and NPDR, seeking its approval.
The company is also currently gearing up to advance its second clinical candidate, KSI-501, a dual inhibitor Trap-Antibody-Fusion bioconjugate molecule, into a phase III DAYBREAK study to evaluate its efficacy, durability and safety in wet AMD later in 2024.
Kodiak plans to study tarcocimab as a second investigational arm in the DAYBREAK study in wet AMD, with KSI-501 being the first investigational arm.
The DAYBREAK study is designed to compare KSI-501 and tarcocimab head-to-head with Regeneron’s Eylea. Pending discussion with the FDA, the company plans to initiate the DAYBREAK study as soon as regulatory alignment is completed, i.e., by mid-2024.
The initiation of a second phase III study will give Kodiak two late-stage candidates, which is expected to provide some sort of a cushion to the company in terms of a fallback option in case one of the programs faces a setback.
Kodiak Sciences Inc. Price and Consensus
Kodiak Sciences Inc. price-consensus-chart | Kodiak Sciences Inc. Quote
KOD is simultaneously planning to initiate an early-stage study of the unconjugated protein portion of KSI-501, KSI-101 (formerly known as KSI-501P), for patients who have retinal fluid and inflammation.
Despite the encouraging developmental updates of pipeline candidates, clinical studies involve a high degree of risk, being prone to setbacks. The developmental timeline of tarcocimab has already been delayed significantly.
The company’s other developmental candidate, KSI-501, has yet to begin late-stage clinical development and is years away from commercialization. Possible setbacks in any of the two developmental programs will further hurt the stock. Kodiak’s portfolio is also devoid of collaboration contracts for product development/commercialization, which remains a concern.
Regeneron’s Eylea is one of its key growth drivers, which is being already approved for wet AMD, DME, RVO and diabetic retinopathy in the United States.The FDA has also approved Eylea to treat preterm infants with retinopathy of prematurity as well.
Please note that Bayer’s (BAYRY - Free Report) HealthCare unit co-develops Eylea with Regeneron. REGN records net product sales of Eylea in the United States. Bayer records net product sales of Eylea outside the United States. Regeneron records its share of profits/losses in connection with sales of Eylea outside the United States.
Zacks Rank and Stock to Consider
Kodiak currently carries a Zacks Rank #3 (Hold).
A better-ranked stock from the drug/biotech industry is ADMA Biologics (ADMA - Free Report) , sporting a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 30 days, the Zacks Consensus Estimate for ADMA Biologics’ 2024 earnings per share (EPS) has remained constant at 30 cents. During the same period, the estimate for ADMA’s 2025 EPS has remained constant at 50 cents. Year to date, shares of ADMA have soared 40.3%.
ADMA beat estimates in three of the trailing four quarters and matched in one, delivering an average earnings surprise of 85%.