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Bayer Gets FDA Priority Review for Asundexian NDA in Stroke Prevention
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Key Takeaways
Bayer's FDA filing for asundexian in stroke prevention received Priority Review status.
BAYRY's phase III study showed a 26% drop in ischemic stroke risk versus placebo.
Bayer said asundexian cut stroke risk without increasing major bleeding in the study.
Bayer (BAYRY - Free Report) announced that the FDA has accepted its new drug application (NDA) for its investigational, once-daily, oral Factor XIa inhibitor, asundexian, for preventing ischemic stroke in patients following a non-cardioembolic ischemic stroke or transient ischemic attack. The FDA also granted the therapy Priority Review status, potentially accelerating the regulatory review process in the United States. The NDA for the candidate for the same indication has also been simultaneously accepted for review in Japan.
A filing accepted under the FDA’s Priority Review pathway reduces the review period to six months from the standard 10 months. This status is awarded to marketing applications for medicines intended to treat serious conditions and that, if approved, would offer a substantial improvement in safety, effectiveness, prevention, or diagnosis of such conditions.
Asundexian is being developed as a secondary stroke prevention therapy at a time when recurrent stroke risk remains a major concern despite currently available treatment options. Bayer noted that roughly 12 million people worldwide suffer a stroke annually, with about one in 10 survivors experiencing another stroke within a year. More than 90 million people globally are estimated to be living with the long-term effects of stroke.
Shares of Bayer have gained 1.9% year to date against the industry’s 2% decline.
Image Source: Zacks Investment Research
BAYRY’s NDA for Asundexian Supported by Phase III Data
Bayer’s NDA 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 prevention of ischemic stroke in patients after a non-cardioembolic ischemic stroke or high-risk transient ischemic attack (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 recurrent stroke risk remains high.
BAYRY is also pursuing broader global regulatory approvals for asundexian. 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 65.2% 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 $3.03 to $3.35. Over the same period, EPS estimates for 2027 have risen to $3.69 from $3.46. INDV shares have risen 1.8% year to date.
Indivior Pharmaceuticals’ earnings beat estimates in each of the trailing four quarters, with the average surprise being 65.44%.
Over the past 60 days, estimates for Immunocore’s 2026 loss per share have narrowed from 97 cents to 16 cents. On the other hand, its 2026 EPS is currently pegged at 11 cents. IMCR shares have lost 18.3% 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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Bayer Gets FDA Priority Review for Asundexian NDA in Stroke Prevention
Key Takeaways
Bayer (BAYRY - Free Report) announced that the FDA has accepted its new drug application (NDA) for its investigational, once-daily, oral Factor XIa inhibitor, asundexian, for preventing ischemic stroke in patients following a non-cardioembolic ischemic stroke or transient ischemic attack. The FDA also granted the therapy Priority Review status, potentially accelerating the regulatory review process in the United States. The NDA for the candidate for the same indication has also been simultaneously accepted for review in Japan.
A filing accepted under the FDA’s Priority Review pathway reduces the review period to six months from the standard 10 months. This status is awarded to marketing applications for medicines intended to treat serious conditions and that, if approved, would offer a substantial improvement in safety, effectiveness, prevention, or diagnosis of such conditions.
Asundexian is being developed as a secondary stroke prevention therapy at a time when recurrent stroke risk remains a major concern despite currently available treatment options. Bayer noted that roughly 12 million people worldwide suffer a stroke annually, with about one in 10 survivors experiencing another stroke within a year. More than 90 million people globally are estimated to be living with the long-term effects of stroke.
Shares of Bayer have gained 1.9% year to date against the industry’s 2% decline.
Image Source: Zacks Investment Research
BAYRY’s NDA for Asundexian Supported by Phase III Data
Bayer’s NDA 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 prevention of ischemic stroke in patients after a non-cardioembolic ischemic stroke or high-risk transient ischemic attack (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 recurrent stroke risk remains high.
BAYRY is also pursuing broader global regulatory approvals for asundexian. 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 currently sporting a Zacks Rank #1 (Strong Buy). 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 65.2% 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 $3.03 to $3.35. Over the same period, EPS estimates for 2027 have risen to $3.69 from $3.46. INDV shares have risen 1.8% year to date.
Indivior Pharmaceuticals’ earnings beat estimates in each of the trailing four quarters, with the average surprise being 65.44%.
Over the past 60 days, estimates for Immunocore’s 2026 loss per share have narrowed from 97 cents to 16 cents. On the other hand, its 2026 EPS is currently pegged at 11 cents. IMCR shares have lost 18.3% 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%.