Bayer's Asundexian Shows 26% Stroke Reduction in Late-Stage Study

Bayer BAYRY presented positive results from the late-stage OCEANIC-STROKE study evaluating the use of its investigational, once-daily, oral, factor XIa inhibitor asundexian (50mg) compared to placebo, both in combination with antiplatelet therapy.

Asundexian is being evaluated as a potential treatment for secondary stroke prevention. The results were presented at the International Stroke Conference (ISC) 2026.

Per Bayer, OCEANIC-STROKE is the first successfully completed phase III study of a factor XIa inhibitor, which demonstrated superiority in reducing recurrent ischemic stroke compared to placebo.

More on BAYRY’s Asundexian

The phase III OCEANIC-STROKE (n=12,327 patients) investigated 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 (TIA) in combination with antiplatelet therapy.

The primary endpoint was time to ischemic stroke and the primary safety endpoint was major bleeding.

Asundexian significantly reduced ischemic stroke by 26% in patients after a non-cardioembolic ischemic stroke or high-risk transient ischemic attack, with no increase in the risk of ISTH (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.

Regulatory momentum also appears favorable. Asundexian has already received Fast Track designation from the FDA for stroke prevention following non-cardioembolic ischemic stroke, and Bayer plans to submit the OCEANIC-STROKE data to regulatory authorities for marketing approval.

Asundexian is viewed as a potential blockbuster opportunity in a market where recurrent stroke risk remains high.

Bayer Advances Cardiovascular Portfolio

A potential approval of asundexian will strengthen BAYRY’s cardiovascular portfolio, which comprises Kerendia.

In 2025, the FDA approved a label expansion of Kerendia for the treatment of adult patients with heart failure (HF) and a left ventricular ejection fraction (LVEF) of ≥40%.

With the latest FDA approval, Kerendia has become the only non-steroidal mineralocorticoid receptor antagonist approved in the United States for chronic kidney disease associated with type 2 diabetes and for HF with LVEF of ≥40%.

Additional regulatory reviews are underway globally, while ongoing phase III programs further broaden Kerendia’s addressable population across cardiovascular-kidney-metabolic conditions.

The European Commission granted marketing authorization to Beyonttra (acoramidis), marketed by Bridge Bio in the United States, to treat wild-type or variant transthyretin amyloidosis in adult patients with cardiomyopathy (ATTR-CM).

Bayer is also shaping the future of cardiology through next-generation assets, including AB-1002, a single-dose gene therapy for congestive heart failure developed with AskBio, which is progressing in phase II, and several early- and mid-stage programs targeting thrombosis, atrial fibrillation and genetically defined cardiomyopathies.

The company also secured exclusive rights in Japan to aficamten from Cytokinetics CYTK. The candidate is a cardiac myosin inhibitor in development for hypertrophic cardiomyopathy.

Cytokinetics recently won FDA approval for aficamten for the treatment of patients with obstructive HCM (in the United States), under the brand name Myqorzo.

Strategic partnerships and licensing deals further enhance Bayer’s precision cardiology portfolio.

Shares have skyrocketed 151.9% over the past year compared with the industry’s gain of 14%. The stupendous performance can be attributed to new drug approvals, encouraging pipeline progress, improved performance of the Crop Science business and positive updates on the ongoing litigations.

Bayer’s new drugs, such as prostate cancer drug Nubeqa and Kerendia, continue to maintain their impressive momentum in the Pharmaceutical division and offset the negative impact of a decline in Xarelto sales.

The strong performance of these drugs makes up for the decline in sales of oral anticoagulant Xarelto, which is co-developed with Johnson & Johnson JNJ.

Xarelto is marketed by Johnson & Johnson in the United States. Bayer earns license revenues from JNJ for Xarelto sales in the United States.

Eylea sales continue to face pressure from generics. The introduction of Eylea 8 mg, with its extended dosing intervals, has partially offset the decline and supported its overall performance.

Label expansion of key drugs and approval of additional drugs should further boost sales from this business.

BAYRY currently carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
 

 

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