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EMA Begins Review of Bayer's Asundexian Filing for Stroke Prevention
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Key Takeaways
Bayer's EMA filing for asundexian was validated, starting centralized review for stroke prevention.
BAYRY's phase III study showed a 26% drop in ischemic stroke risk compared to placebo.
Bayer said asundexian reduced stroke risk without increasing major bleeding in the study.
Bayer (BAYRY - Free Report) announced that the European Medicines Agency (EMA) has validated the marketing authorization application for its investigational, once-daily, oral Factor XIa inhibitor, asundexian, for the prevention of ischemic stroke in adults after a non-cardioembolic ischemic stroke or a high-risk transient ischemic attack (TIA). This marks the completion of the regulatory application submission process and the beginning of the EMA’s centralized review procedure.
Bayer noted that stroke is an increasing public health challenge, affecting approximately 10 million people in Europe living with its long-term consequences, while more than one million new cases are reported each year. BAYRY added that stroke remains the world's and Europe's second-leading cause of death, placing a substantial burden on healthcare systems, with global costs estimated at $891 billion annually.
Shares of Bayer have lost 6.1% year to date against the industry’s 4.8% growth.
Image Source: Zacks Investment Research
BAYRY’s EU Filing for Asundexian Supported by Phase III Data
Bayer’s marketing application for asundexian to the EMA is supported by encouraging data from the phase III OCEANIC-STROKE study. The study investigated the efficacy and safety of asundexian 50 mg compared to placebo for the prevention of ischemic stroke in patients after a non-cardioembolic ischemic stroke or high-risk TIA in combination with antiplatelet therapy. It enrolled 12,327 patients worldwide.
The primary efficacy endpoint was time to ischemic stroke, and the primary safety endpoint was major bleeding.
Bayer reported that in the OCEANIC-STROKE study, asundexian significantly reduced ischemic stroke by 26% in patients after a non-cardioembolic ischemic stroke or high-risk TIA, compared to placebo, both in combination with antiplatelet therapy, with no increase in the risk of International Society on Thrombosis and Hemostasis major bleeding.
The benefit was consistent across all major patient subgroups, regardless of age, sex, stroke subtype, stroke severity, or background antiplatelet regimen. Asundexian is viewed as a potential blockbuster opportunity in a market where the risk of recurrent stroke remains high.
Bayer is also pursuing broader global regulatory approvals for asundexian. Last month, the FDA accepted BAYRY’s regulatory filing for asundexian to prevent ischemic stroke in patients following a non-cardioembolic ischemic stroke or TIA under its Priority Review pathway, potentially accelerating the regulatory review process in the United States. A filing for the candidate for the same indication is also currently under review in Japan.
In addition to the U.S. and Japan filings, China’s regulatory body also recently accepted Bayer’s marketing authorization application for the therapy to treat the above indication and granted it Priority Review designation.
Over the past 60 days, estimates for Liquidia Corporation’s 2026 EPS have increased from $1.50 to $2.97. Over the same period, EPS estimates for 2027 have also increased from $2.91 to $4.81. LQDA shares have rallied 89.2% year to date.
Liquidia Corporation’searnings beat estimates in three of the trailing four quarters and missed in the remaining one, with the average surprise being 54.40%.
Over the past 60 days, estimates for Indivior Pharmaceuticals’ 2026 earnings per share have increased from $3.33 to $4.05. Over the same period, EPS estimates for 2027 have risen to $4.27 from $3.66. INDV shares have gained 6.1% year to date.
Indivior Pharmaceuticals’ earnings beat estimates in each of the trailing four quarters, with the average surprise being 65.44%.
The estimate for Immunocore’s 2026 EPS is currently pegged at 6 cents. In the past 60 days, the estimates for its 2027 EPS have increased from 24 cents to 87 cents. IMCR shares have lost 19.6% year to date.
Immunocore’s earnings beat estimates in three of the trailing four quarters, while missing the same on the remaining occasion, with the average surprise being 46.66%.
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EMA Begins Review of Bayer's Asundexian Filing for Stroke Prevention
Key Takeaways
Bayer (BAYRY - Free Report) announced that the European Medicines Agency (EMA) has validated the marketing authorization application for its investigational, once-daily, oral Factor XIa inhibitor, asundexian, for the prevention of ischemic stroke in adults after a non-cardioembolic ischemic stroke or a high-risk transient ischemic attack (TIA). This marks the completion of the regulatory application submission process and the beginning of the EMA’s centralized review procedure.
Bayer noted that stroke is an increasing public health challenge, affecting approximately 10 million people in Europe living with its long-term consequences, while more than one million new cases are reported each year. BAYRY added that stroke remains the world's and Europe's second-leading cause of death, placing a substantial burden on healthcare systems, with global costs estimated at $891 billion annually.
Shares of Bayer have lost 6.1% year to date against the industry’s 4.8% growth.
Image Source: Zacks Investment Research
BAYRY’s EU Filing for Asundexian Supported by Phase III Data
Bayer’s marketing application for asundexian to the EMA is supported by encouraging data from the phase III OCEANIC-STROKE study. The study investigated the efficacy and safety of asundexian 50 mg compared to placebo for the prevention of ischemic stroke in patients after a non-cardioembolic ischemic stroke or high-risk TIA in combination with antiplatelet therapy. It enrolled 12,327 patients worldwide.
The primary efficacy endpoint was time to ischemic stroke, and the primary safety endpoint was major bleeding.
Bayer reported that in the OCEANIC-STROKE study, asundexian significantly reduced ischemic stroke by 26% in patients after a non-cardioembolic ischemic stroke or high-risk TIA, compared to placebo, both in combination with antiplatelet therapy, with no increase in the risk of International Society on Thrombosis and Hemostasis major bleeding.
The benefit was consistent across all major patient subgroups, regardless of age, sex, stroke subtype, stroke severity, or background antiplatelet regimen. Asundexian is viewed as a potential blockbuster opportunity in a market where the risk of recurrent stroke remains high.
Bayer is also pursuing broader global regulatory approvals for asundexian. Last month, the FDA accepted BAYRY’s regulatory filing for asundexian to prevent ischemic stroke in patients following a non-cardioembolic ischemic stroke or TIA under its Priority Review pathway, potentially accelerating the regulatory review process in the United States. A filing for the candidate for the same indication is also currently under review in Japan.
In addition to the U.S. and Japan filings, China’s regulatory body also recently accepted Bayer’s marketing authorization application for the therapy to treat the above indication and granted it Priority Review designation.
Bayer Aktiengesellschaft Price and Consensus
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BAYRY’s Zacks Rank & Other Stocks to Consider
Bayer currently carries a Zacks Rank #2 (Buy).
Some other top-ranked stocks in the biotech sector are Liquidia Corporation (LQDA - Free Report) , Indivior Pharmaceuticals (INDV - Free Report) and Immunocore (IMCR - 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.
Over the past 60 days, estimates for Liquidia Corporation’s 2026 EPS have increased from $1.50 to $2.97. Over the same period, EPS estimates for 2027 have also increased from $2.91 to $4.81. LQDA shares have rallied 89.2% year to date.
Liquidia Corporation’searnings beat estimates in three of the trailing four quarters and missed in the remaining one, with the average surprise being 54.40%.
Over the past 60 days, estimates for Indivior Pharmaceuticals’ 2026 earnings per share have increased from $3.33 to $4.05. Over the same period, EPS estimates for 2027 have risen to $4.27 from $3.66. INDV shares have gained 6.1% year to date.
Indivior Pharmaceuticals’ earnings beat estimates in each of the trailing four quarters, with the average surprise being 65.44%.
The estimate for Immunocore’s 2026 EPS is currently pegged at 6 cents. In the past 60 days, the estimates for its 2027 EPS have increased from 24 cents to 87 cents. IMCR shares have lost 19.6% year to date.
Immunocore’s earnings beat estimates in three of the trailing four quarters, while missing the same on the remaining occasion, with the average surprise being 46.66%.