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Bayer (BAYRY) Stops Heart Drug Study Due to Lack of Efficacy
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Bayer Health (BAYRY - Free Report) suffered a setback as the late-stage study, OCEANIC-AF, investigating asundexian compared with direct oral anticoagulant Eliquis (apixaban) in patients with atrial fibrillation (“AF”) at risk for stroke is being stopped early.
This multicenter, international, randomized, active comparator-controlled, double-blind, double-dummy, parallel-group, 2-arm phase III study was evaluating the safety and efficacy of asundexian in preventing stroke and systemic embolism versus Eliquis.
AF, one of the most commonly sustained cardiac rhythm disorders (arrhythmias), results from rapid, disorganized electrical signals in the upper chambers (atria) of the heart, causing them to quiver and contract quickly and irregularly. This results in blood clots, which can break loose and travel to the brain, resulting in a stroke.
The decision to stop the OCEANIC-AF study was based on the recommendation of the study’s Independent Data Monitoring Committee (“IDMC”) as part of the ongoing surveillance, which showed an inferior efficacy of asundexian versus the control arm.
Nevertheless, IDMC recommends continuing the phase III OCEANIC-STROKE study as planned.
OCEANIC-STROKE is a phase III multicenter, international, randomized, placebo-controlled, double-blind, parallel-group and event-driven study evaluating the efficacy and safety of asundexian for the prevention of ischemic stroke compared with placebo on top of standard-of-care antiplatelet therapy in patients after an acute non-cardioembolic ischemic stroke or high-risk transient ischemic attack/mini-stroke.
The failure of the study disappointed investors.
Concurrently, the company faced another setback. On Nov 17, 2023, the jury ruled in favor of the plaintiffs in the Anderson trial and awarded them $61.2 million in compensatory damages and $1.5 billion in punitive damages. The trial is related to glyphosate litigation in the United States. Bayer will appeal this decision. The plaintiffs claim that Bayer’s Roundup weedkiller caused severe injuries, including cancer.
Bayer acquired Roundup weedkiller through Monsanto’s acquisition in 2018.
Shares of Bayer have declined 12.2% year-to-date against the industry’s growth of 3.8%.
Image Source: Zacks Investment Research
Litigation charges related to the Roundup Litigation have hit the company.
The going has been challenging for Bayer of late. The Crop Science division has been adversely impacted due to lower volumes and decreased prices for glyphosate-based products. Consequently, the company previously lowered its annual outlook.
Zacks Rank & Stocks to Consider
Bayer currently has a Zacks Rank #5 (Strong Sell).
Earnings estimates for Ligand Pharmaceuticals’ 2023 earnings per share have increased from $4.98 to $5.10 in the past 60 days. During the same period, earnings estimates for 2024 rose from $4.26 to $4.59.
Ligand beat earnings estimates in each of the last four quarters. The company has delivered an earnings surprise of 67.19%, on average.
Dynavax’s loss per share estimates for 2023 have narrowed from 23 cents to 12 cents for 2023 in the past 30 days. During the same period, earnings estimates for 2024 rose from 3 cents to 18 cents. Shares of DVAX have gained 28.5% year to date.
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Bayer (BAYRY) Stops Heart Drug Study Due to Lack of Efficacy
Bayer Health (BAYRY - Free Report) suffered a setback as the late-stage study, OCEANIC-AF, investigating asundexian compared with direct oral anticoagulant Eliquis (apixaban) in patients with atrial fibrillation (“AF”) at risk for stroke is being stopped early.
This multicenter, international, randomized, active comparator-controlled, double-blind, double-dummy, parallel-group, 2-arm phase III study was evaluating the safety and efficacy of asundexian in preventing stroke and systemic embolism versus Eliquis.
AF, one of the most commonly sustained cardiac rhythm disorders (arrhythmias), results from rapid, disorganized electrical signals in the upper chambers (atria) of the heart, causing them to quiver and contract quickly and irregularly. This results in blood clots, which can break loose and travel to the brain, resulting in a stroke.
The decision to stop the OCEANIC-AF study was based on the recommendation of the study’s Independent Data Monitoring Committee (“IDMC”) as part of the ongoing surveillance, which showed an inferior efficacy of asundexian versus the control arm.
Nevertheless, IDMC recommends continuing the phase III OCEANIC-STROKE study as planned.
OCEANIC-STROKE is a phase III multicenter, international, randomized, placebo-controlled, double-blind, parallel-group and event-driven study evaluating the efficacy and safety of asundexian for the prevention of ischemic stroke compared with placebo on top of standard-of-care antiplatelet therapy in patients after an acute non-cardioembolic ischemic stroke or high-risk transient ischemic attack/mini-stroke.
The failure of the study disappointed investors.
Concurrently, the company faced another setback. On Nov 17, 2023, the jury ruled in favor of the plaintiffs in the Anderson trial and awarded them $61.2 million in compensatory damages and $1.5 billion in punitive damages. The trial is related to glyphosate litigation in the United States. Bayer will appeal this decision. The plaintiffs claim that Bayer’s Roundup weedkiller caused severe injuries, including cancer.
Bayer acquired Roundup weedkiller through Monsanto’s acquisition in 2018.
Shares of Bayer have declined 12.2% year-to-date against the industry’s growth of 3.8%.
Image Source: Zacks Investment Research
Litigation charges related to the Roundup Litigation have hit the company.
The going has been challenging for Bayer of late. The Crop Science division has been adversely impacted due to lower volumes and decreased prices for glyphosate-based products. Consequently, the company previously lowered its annual outlook.
Zacks Rank & Stocks to Consider
Bayer currently has a Zacks Rank #5 (Strong Sell).
A couple of top-ranked stocks in the overall healthcare sector are Ligand Pharmaceuticals (LGND - Free Report) and Dynavax Technologies (DVAX - Free Report) . While LGND sports a Zacks Rank #1 (Strong Buy), DVAX carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Earnings estimates for Ligand Pharmaceuticals’ 2023 earnings per share have increased from $4.98 to $5.10 in the past 60 days. During the same period, earnings estimates for 2024 rose from $4.26 to $4.59.
Ligand beat earnings estimates in each of the last four quarters. The company has delivered an earnings surprise of 67.19%, on average.
Dynavax’s loss per share estimates for 2023 have narrowed from 23 cents to 12 cents for 2023 in the past 30 days. During the same period, earnings estimates for 2024 rose from 3 cents to 18 cents. Shares of DVAX have gained 28.5% year to date.