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Bayer's (BAYRY) Arrhythmia Prevention Drug Gets Fast Track Tag
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Bayer Aktiengesellschaft (BAYRY - Free Report) announced that the FDA has granted Fast Track Designation (FTD) to its investigational drug, asundexian, as a potential treatment to prevent stroke and systemic embolism in people with atrial fibrillation (AF).
We would like to remind the investors that asundexian was first granted FTD in 2022 for the prevention of stroke in patients after a non-cardioembolic ischemic stroke.
In the past year, shares of Bayer have plunged 11.4% against the industry’s 12.2% rise.
Image Source: Zacks Investment Research
Asundexian is a potential once-daily oral Factor XIa (FXIa) inhibitor. Bayer is currently evaluating asundexian in the OCEANIC-AF study — part of the phase III OCEANIC clinical program — as a thrombosis prevention drug, aiming to reduce clot formation while leaving the body’s ability to respond to bleeding intact.
The phase III OCEANIC clinical program is a multinational study designed to evaluate asundexian in patients with AF to risk of stroke and in patients with acute non-cardioembolic ischemic stroke or high-risk transient ischemic attack. The study aims at improving the benefit-risk profile when compared to current treatment options. The clinical program, which currently consists of two arms, OCEANIC-AF and OCEANIC-STROKE, expects to enroll over 27000 patients from over 40 countries.
The FTD is intended to facilitate the development process of the drug by expediting the review process to treat serious medical conditions, thereby fulfilling such needs. The designation makes the candidate eligible for more frequent discussions with the FDA regarding its development plan. The FTD could consequentially lead to an Accelerated Approval and Priority Review, subject to meeting relevant criteria.
According to popular studies, an estimated 40% of eligible patients are either not treated with direct oral anticoagulants or are undertreated, as they are more intimidated by the risk of experiencing bleeding than their need for thrombosis prevention. Bayer expects to make a breakthrough in this context. The inhibition of FXIa by asundexian will protect patients from thrombotic events without a corresponding increase in bleeding risk.
In the past 60 days, estimates for Novo Nordisk’s 2023 earnings per share have increased from $4.43 to $4.95. Shares of Novo Nordisk have increased 62% in the past year.
Earnings of Novo Nordisk beat estimates in three of the last four quarters and missed the mark on one occasion, witnessing an earnings surprise of 0.35%, on average.
In the past 60 days, estimates for Novartis’ 2023 earnings per share have increased from $6.55 to $6.67. Shares of NVS have increased 17.3% in the past year.
Earnings of NVS beat estimates in each of the last four quarters, witnessing an earnings surprise of 5.15%, on average.
In the past 60 days, the Zacks Consensus Estimate for Allogene Therapeutics’ 2023 loss per share has narrowed from $2.50 to $2.32. In the past year, shares of Allogene Therapeutics have fallen by 15.7%.
ALLO beat estimates in three of the trailing four quarters, missing the mark on one occasion, delivering an average earnings surprise of 5.08%.
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Bayer's (BAYRY) Arrhythmia Prevention Drug Gets Fast Track Tag
Bayer Aktiengesellschaft (BAYRY - Free Report) announced that the FDA has granted Fast Track Designation (FTD) to its investigational drug, asundexian, as a potential treatment to prevent stroke and systemic embolism in people with atrial fibrillation (AF).
We would like to remind the investors that asundexian was first granted FTD in 2022 for the prevention of stroke in patients after a non-cardioembolic ischemic stroke.
In the past year, shares of Bayer have plunged 11.4% against the industry’s 12.2% rise.
Image Source: Zacks Investment Research
Asundexian is a potential once-daily oral Factor XIa (FXIa) inhibitor. Bayer is currently evaluating asundexian in the OCEANIC-AF study — part of the phase III OCEANIC clinical program — as a thrombosis prevention drug, aiming to reduce clot formation while leaving the body’s ability to respond to bleeding intact.
The phase III OCEANIC clinical program is a multinational study designed to evaluate asundexian in patients with AF to risk of stroke and in patients with acute non-cardioembolic ischemic stroke or high-risk transient ischemic attack. The study aims at improving the benefit-risk profile when compared to current treatment options. The clinical program, which currently consists of two arms, OCEANIC-AF and OCEANIC-STROKE, expects to enroll over 27000 patients from over 40 countries.
The FTD is intended to facilitate the development process of the drug by expediting the review process to treat serious medical conditions, thereby fulfilling such needs. The designation makes the candidate eligible for more frequent discussions with the FDA regarding its development plan. The FTD could consequentially lead to an Accelerated Approval and Priority Review, subject to meeting relevant criteria.
According to popular studies, an estimated 40% of eligible patients are either not treated with direct oral anticoagulants or are undertreated, as they are more intimidated by the risk of experiencing bleeding than their need for thrombosis prevention. Bayer expects to make a breakthrough in this context. The inhibition of FXIa by asundexian will protect patients from thrombotic events without a corresponding increase in bleeding risk.
Bayer Aktiengesellschaft Price and Consensus
Bayer Aktiengesellschaft price-consensus-chart | Bayer Aktiengesellschaft Quote
Zacks Rank and Stocks to Consider
Bayer currently has a Zacks Rank #4 (Sell).
Some better-ranked stocks from the overall medical sector include Novo Nordisk (NVO - Free Report) , Novartis (NVS - Free Report) and Allogene Therapeutics (ALLO - Free Report) . While Novo Nordisk currently sports a Zacks Rank #1 (Strong Buy), Novartis and Allogene, both have a Zacks Rank #2 (Buy), at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 60 days, estimates for Novo Nordisk’s 2023 earnings per share have increased from $4.43 to $4.95. Shares of Novo Nordisk have increased 62% in the past year.
Earnings of Novo Nordisk beat estimates in three of the last four quarters and missed the mark on one occasion, witnessing an earnings surprise of 0.35%, on average.
In the past 60 days, estimates for Novartis’ 2023 earnings per share have increased from $6.55 to $6.67. Shares of NVS have increased 17.3% in the past year.
Earnings of NVS beat estimates in each of the last four quarters, witnessing an earnings surprise of 5.15%, on average.
In the past 60 days, the Zacks Consensus Estimate for Allogene Therapeutics’ 2023 loss per share has narrowed from $2.50 to $2.32. In the past year, shares of Allogene Therapeutics have fallen by 15.7%.
ALLO beat estimates in three of the trailing four quarters, missing the mark on one occasion, delivering an average earnings surprise of 5.08%.