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BAYRYs Cardiovascular Drug Hits Goals in Late-Stage Study
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Key Takeaways
BAYRY says asundexian met primary efficacy and safety endpoints in the OCEANIC-STROKE study.
The drug cut ischemic stroke risk versus placebo when added to antiplatelet therapy.
BAYRY plans global filings after results showed no rise in ISTH major bleeding with asundexian.
Bayer AG (BAYRY - Free Report) announced that pipeline candidate asundexian met primary efficacy and safety endpoints in late-stage OCEANIC-STROKE Study in secondary stroke prevention.
Results from the study showed that asundexian 50 mg once daily significantly reduced the risk of ischemic stroke compared to placebo, both in combination with antiplatelet therapy, in patients after a non-cardioembolic ischemic stroke or high-risk transient ischemic attack.
Bayer will work with health authorities worldwide to submit marketing authorization applications seeking approval for the candidate.
More on BAYRY’s Cardiovascular Drug
The phase III randomized, placebo-controlled, double-blind, OCEANIC-STROKE study evaluated the efficacy and safety of the oral Factor XIa inhibitor asundexian 50 mg once daily compared to placebo, for prevention of ischemic stroke in patients after a non-cardioembolic ischemic stroke or high-risk transient ischemic attack in combination with antiplatelet therapy.
Results from this study demonstrate superiority of asundexian with antiplatelet therapy, showing significant reduction in ischemic stroke risk, without increasing ISTH major bleeding rate, compared to placebo with antiplatelet therapy.
Per BAYRY, OCEANIC-STROKE is the first completed phase III study of a factor XIa inhibitor.
Per estimates, approximately 12 million people experience a stroke worldwide annually. Among these, 20-30% will have a recurrent stroke.
Despite existing therapies for secondary stroke prevention, the risk of recurrence remains substantial. One in five stroke survivors experiences another stroke within five years. Stroke is the world’s second leading cause of death, and recurrent ischemic events are typically more disabling and associated with higher mortality than the initial stroke.
The FDA granted Fast Track Designation to asundexian as a potential treatment for stroke prevention in patients after a non-cardioembolic ischemic stroke. The successful development of the candidate will be a significant boost for BAYRY’s pharmaceutical portfolio, given the prevalence of secondary stroke.
BAYRY’s Efforts to Broaden Portfolio Impressive
Bayer is looking to broaden and diversify its pharmaceutical business, and the recent progress has been impressive.
Bayer’s key drugs, Nubeqa for cancer and Kerendia for chronic kidney disease associated with type II diabetes, are fueling growth in its pharmaceuticals division, making up for the decline in sales of oral anticoagulant Xarelto, which is co-developed with Johnson & Johnson (JNJ - Free Report) .
Xarelto is marketed by Johnson & Johnson in the United States. Bayer earns license revenues from JNJ for Xarelto sales in the United States.
Approval of additional drugs and label expansion of key drugs will further boost sales from this business.
Bayer is also working to expand the labels of Nubeqa and Kerendia, which, if successful, can further drive growth.
Year to date, shares of Bayer have surged 62.7% compared with the industry’s gain of 16%.
Image Source: Zacks Investment Research
The European Commission recently approved elinzanetant for the treatment of moderate to severe vasomotor symptoms (VMS, also known as hot flashes) associated with menopause or caused by adjuvant endocrine therapy (AET) related to breast cancer, under the brand name Lynkuet. The drug is already approved in the UK and the United States for the treatment of VMS associated with menopause.
The FDA recently granted accelerated approval to Hyrnuo (sevabertinib) for the treatment of adult patients with locally advanced or metastatic non-squamous non-small cell lung cancer whose tumors have human epidermal growth factor receptor 2 tyrosine kinase domain activating mutations, as detected by an FDA-approved test, and who have received a prior systemic therapy.
Bayer is making good pipeline progress as well. The new drug application for investigational contrast agent, gadoquatrane, has been accepted for review in both the United States and China. Gadoquatrane is being developed for use in contrast-enhanced magnetic resonance imaging of the central nervous system and other body regions in adults and pediatric patients, including term neonates.
In the past 60 days, estimates for Amicus Therapeutics’ 2025 EPS have increased to 34 cents from 31 cents. During the same time, EPS estimates for 2026 have decreased to 67 cents from 69 cents. Year to date, shares of FOLD have gained 1.5%.
In the past 60 days, estimates for CorMedix’s 2025 EPS have increased from $1.52 to $2.90. EPS estimates for 2026 have moved up from $2.09 to $2.72 during the same period. CRMD stock has surged 19.5% year to date.
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BAYRYs Cardiovascular Drug Hits Goals in Late-Stage Study
Key Takeaways
Bayer AG (BAYRY - Free Report) announced that pipeline candidate asundexian met primary efficacy and safety endpoints in late-stage OCEANIC-STROKE Study in secondary stroke prevention.
Results from the study showed that asundexian 50 mg once daily significantly reduced the risk of ischemic stroke compared to placebo, both in combination with antiplatelet therapy, in patients after a non-cardioembolic ischemic stroke or high-risk transient ischemic attack.
Bayer will work with health authorities worldwide to submit marketing authorization applications seeking approval for the candidate.
More on BAYRY’s Cardiovascular Drug
The phase III randomized, placebo-controlled, double-blind, OCEANIC-STROKE study evaluated the efficacy and safety of the oral Factor XIa inhibitor asundexian 50 mg once daily compared to placebo, for prevention of ischemic stroke in patients after a non-cardioembolic ischemic stroke or high-risk transient ischemic attack in combination with antiplatelet therapy.
Results from this study demonstrate superiority of asundexian with antiplatelet therapy, showing significant reduction in ischemic stroke risk, without increasing ISTH major bleeding rate, compared to placebo with antiplatelet therapy.
Per BAYRY, OCEANIC-STROKE is the first completed phase III study of a factor XIa inhibitor.
Per estimates, approximately 12 million people experience a stroke worldwide annually. Among these, 20-30% will have a recurrent stroke.
Despite existing therapies for secondary stroke prevention, the risk of recurrence remains substantial. One in five stroke survivors experiences another stroke within five years. Stroke is the world’s second leading cause of death, and recurrent ischemic events are typically more disabling and associated with higher mortality than the initial stroke.
The FDA granted Fast Track Designation to asundexian as a potential treatment for stroke prevention in patients after a non-cardioembolic ischemic stroke. The successful development of the candidate will be a significant boost for BAYRY’s pharmaceutical portfolio, given the prevalence of secondary stroke.
BAYRY’s Efforts to Broaden Portfolio Impressive
Bayer is looking to broaden and diversify its pharmaceutical business, and the recent progress has been impressive.
Bayer’s key drugs, Nubeqa for cancer and Kerendia for chronic kidney disease associated with type II diabetes, are fueling growth in its pharmaceuticals division, making up for the decline in sales of oral anticoagulant Xarelto, which is co-developed with Johnson & Johnson (JNJ - Free Report) .
Xarelto is marketed by Johnson & Johnson in the United States. Bayer earns license revenues from JNJ for Xarelto sales in the United States.
Approval of additional drugs and label expansion of key drugs will further boost sales from this business.
Bayer is also working to expand the labels of Nubeqa and Kerendia, which, if successful, can further drive growth.
Year to date, shares of Bayer have surged 62.7% compared with the industry’s gain of 16%.
Image Source: Zacks Investment Research
The European Commission recently approved elinzanetant for the treatment of moderate to severe vasomotor symptoms (VMS, also known as hot flashes) associated with menopause or caused by adjuvant endocrine therapy (AET) related to breast cancer, under the brand name Lynkuet. The drug is already approved in the UK and the United States for the treatment of VMS associated with menopause.
The FDA recently granted accelerated approval to Hyrnuo (sevabertinib) for the treatment of adult patients with locally advanced or metastatic non-squamous non-small cell lung cancer whose tumors have human epidermal growth factor receptor 2 tyrosine kinase domain activating mutations, as detected by an FDA-approved test, and who have received a prior systemic therapy.
Bayer is making good pipeline progress as well. The new drug application for investigational contrast agent, gadoquatrane, has been accepted for review in both the United States and China. Gadoquatrane is being developed for use in contrast-enhanced magnetic resonance imaging of the central nervous system and other body regions in adults and pediatric patients, including term neonates.
BAYRY's Zacks Rank & Other Stocks to Consider
Bayer currently carries a Zacks Rank #2 (Buy).
A couple of other top-ranked stocks in the biotech sector are Amicus Therapeutics (FOLD - Free Report) and CorMedix (CRMD - Free Report) , each 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 60 days, estimates for Amicus Therapeutics’ 2025 EPS have increased to 34 cents from 31 cents. During the same time, EPS estimates for 2026 have decreased to 67 cents from 69 cents. Year to date, shares of FOLD have gained 1.5%.
In the past 60 days, estimates for CorMedix’s 2025 EPS have increased from $1.52 to $2.90. EPS estimates for 2026 have moved up from $2.09 to $2.72 during the same period. CRMD stock has surged 19.5% year to date.