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Bayer Wins FDA Approval for Sunharbo for Secondary Stroke Risk Reduction
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Key Takeaways
Bayer's Sunharbo wins FDA approval to reduce recurrent stroke risk, marking a major commercial milestone.
Phase III results showed Sunharbo reduced ischemic stroke risk by 26% without increasing major bleeding.
Kerendia and Nubeqa sales support pharmaceutical growth, helping offset declining Eylea and Xarelto revenues.
Bayer (BAYRY - Free Report) received FDA approval for Sunharbo (asundexian), a once-daily oral Factor XIa inhibitor, to reduce the risk of recurrent stroke in adults who have experienced a recent non-cardioembolic ischemic stroke or high-risk transient ischemic attack (TIA).
The drug is approved for use in combination with antiplatelet therapy and is the first Factor XIa inhibitor to receive regulatory approval worldwide.
Reducing the risk of another stroke after an initial event is often referred to as secondary stroke prevention.
The approval is a significant pipeline-to-commercial milestone for Bayer, providing an opportunity to expand its cardiovascular and cerebrovascular franchise into a new therapeutic class. It also positions the company to address a substantial unmet medical need, as approximately one in five survivors of non-cardioembolic ischemic stroke experiences another stroke within five years despite existing preventive treatments.
Shares of Bayer have gained 47% year to date compared with the industry’s 22.5% growth.
Image Source: Zacks Investment Research
More on BAYRY’s Sunharbo Approval
The FDA decision was supported by positive results from the pivotal phase III OCEANIC-STROKE study, which enrolled 12,327 patients globally. The trial demonstrated that Sunharbo, when added to antiplatelet therapy, reduced the risk of ischemic stroke by 26% compared with antiplatelet therapy alone. Importantly, the reduction in stroke risk was achieved without an increase in International Society on Thrombosis and Haemostasis (ISTH)-defined major bleeding compared with placebo.
The clinical findings strengthen Sunharbo's commercial potential by demonstrating a favorable efficacy and safety profile in a large patient population.
Beyond the United States, Sunharbo has received approval in China, while marketing applications in additional markets are under regulatory review. These potential launches could provide Bayer with further revenue opportunities and strengthen its position in cardiovascular and cerebrovascular medicine.
Overall, the approval marks an important growth opportunity for Bayer, although commercial uptake, market penetration and the ability to establish Sunharbo as a standard treatment option will determine its long-term contribution to revenues.
BAYRY's Pharmaceutical Business Drives Growth
Bayer reported third-quarter results last week, with earnings falling short of analysts' expectations. Its Crop Science business faced challenges from unfavorable weather conditions, weighing on overall performance.
However, the Pharmaceuticals business continues to show encouraging momentum. Kerendia has emerged as one of Bayer's strongest growth drivers, with robust third-quarter sales supporting revenues. Nubeqa is another key growth product, benefiting from rising demand in prostate cancer. Further expansion of its use and deeper penetration among eligible patients could support growth as competition intensifies for older drugs.
Strong sales of Kerendia and Nubeqa have helped offset declining revenues from Eylea and Xarelto. Bayer co-develops Eylea with Regeneron (REGN - Free Report) . Regeneron records U.S. net product sales of Eylea and Eylea 8 mg, while Bayer recognizes sales outside the United States. Regeneron also records its share of profits and losses from Eylea sales in international markets.
Meanwhile, Xarelto sales, co-developed with Johnson & Johnson (JNJ - Free Report) , declined 30.7% to €377 million, primarily due to increasing generic competition, particularly in Europe. In the United States, J&J markets Xarelto, while Bayer receives licensing revenues from the drug's U.S. sales.
Bayer has also made regulatory progress across its women's healthcare and oncology portfolios. In September, the FDA granted Priority Review to elinzanetant (Lynkuet) for treating moderate-to-severe vasomotor symptoms, including hot flashes, in women receiving endocrine therapy for hormone receptor-positive breast cancer.
In oncology, Bayer secured approvals for sevabertinib (Hyrnuo) in Japan and the United States. Japan's Ministry of Health, Labour and Welfare approved the drug in August for patients with HER2 mutation-positive, unresectable advanced or recurrent non-small cell lung cancer (NSCLC). In September, the FDA granted accelerated approval to Hyrnuo as a first-line targeted treatment for HER2-mutated NSCLC.
These regulatory milestones broaden Bayer's pharmaceutical portfolio and create additional opportunities in targeted oncology and women's healthcare. Continued growth from newer products and successful commercialization of recently approved therapies could help offset competitive pressures on established brands.
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Image: Bigstock
Bayer Wins FDA Approval for Sunharbo for Secondary Stroke Risk Reduction
Key Takeaways
Bayer (BAYRY - Free Report) received FDA approval for Sunharbo (asundexian), a once-daily oral Factor XIa inhibitor, to reduce the risk of recurrent stroke in adults who have experienced a recent non-cardioembolic ischemic stroke or high-risk transient ischemic attack (TIA).
The drug is approved for use in combination with antiplatelet therapy and is the first Factor XIa inhibitor to receive regulatory approval worldwide.
Reducing the risk of another stroke after an initial event is often referred to as secondary stroke prevention.
The approval is a significant pipeline-to-commercial milestone for Bayer, providing an opportunity to expand its cardiovascular and cerebrovascular franchise into a new therapeutic class. It also positions the company to address a substantial unmet medical need, as approximately one in five survivors of non-cardioembolic ischemic stroke experiences another stroke within five years despite existing preventive treatments.
Shares of Bayer have gained 47% year to date compared with the industry’s 22.5% growth.
Image Source: Zacks Investment Research
More on BAYRY’s Sunharbo Approval
The FDA decision was supported by positive results from the pivotal phase III OCEANIC-STROKE study, which enrolled 12,327 patients globally. The trial demonstrated that Sunharbo, when added to antiplatelet therapy, reduced the risk of ischemic stroke by 26% compared with antiplatelet therapy alone. Importantly, the reduction in stroke risk was achieved without an increase in International Society on Thrombosis and Haemostasis (ISTH)-defined major bleeding compared with placebo.
The clinical findings strengthen Sunharbo's commercial potential by demonstrating a favorable efficacy and safety profile in a large patient population.
Beyond the United States, Sunharbo has received approval in China, while marketing applications in additional markets are under regulatory review. These potential launches could provide Bayer with further revenue opportunities and strengthen its position in cardiovascular and cerebrovascular medicine.
Overall, the approval marks an important growth opportunity for Bayer, although commercial uptake, market penetration and the ability to establish Sunharbo as a standard treatment option will determine its long-term contribution to revenues.
BAYRY's Pharmaceutical Business Drives Growth
Bayer reported third-quarter results last week, with earnings falling short of analysts' expectations. Its Crop Science business faced challenges from unfavorable weather conditions, weighing on overall performance.
However, the Pharmaceuticals business continues to show encouraging momentum. Kerendia has emerged as one of Bayer's strongest growth drivers, with robust third-quarter sales supporting revenues. Nubeqa is another key growth product, benefiting from rising demand in prostate cancer. Further expansion of its use and deeper penetration among eligible patients could support growth as competition intensifies for older drugs.
Strong sales of Kerendia and Nubeqa have helped offset declining revenues from Eylea and Xarelto. Bayer co-develops Eylea with Regeneron (REGN - Free Report) . Regeneron records U.S. net product sales of Eylea and Eylea 8 mg, while Bayer recognizes sales outside the United States. Regeneron also records its share of profits and losses from Eylea sales in international markets.
Meanwhile, Xarelto sales, co-developed with Johnson & Johnson (JNJ - Free Report) , declined 30.7% to €377 million, primarily due to increasing generic competition, particularly in Europe. In the United States, J&J markets Xarelto, while Bayer receives licensing revenues from the drug's U.S. sales.
Bayer has also made regulatory progress across its women's healthcare and oncology portfolios. In September, the FDA granted Priority Review to elinzanetant (Lynkuet) for treating moderate-to-severe vasomotor symptoms, including hot flashes, in women receiving endocrine therapy for hormone receptor-positive breast cancer.
In oncology, Bayer secured approvals for sevabertinib (Hyrnuo) in Japan and the United States. Japan's Ministry of Health, Labour and Welfare approved the drug in August for patients with HER2 mutation-positive, unresectable advanced or recurrent non-small cell lung cancer (NSCLC). In September, the FDA granted accelerated approval to Hyrnuo as a first-line targeted treatment for HER2-mutated NSCLC.
These regulatory milestones broaden Bayer's pharmaceutical portfolio and create additional opportunities in targeted oncology and women's healthcare. Continued growth from newer products and successful commercialization of recently approved therapies could help offset competitive pressures on established brands.
Bayer’s Zacks Rank
BAYRY currently has a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.