Bayer to Present Results From Phase III OCEANIC-STROKE Study of Asundexian in Secondary Stroke Prevention

Key Terms

factor xia medical

Factor XIa is a protein in the blood that helps trigger clotting by acting like a switch that speeds up the chain reaction leading to a clot. Investors care because drugs that block or modify this switch aim to prevent dangerous clots without causing excessive bleeding, so progress in clinical trials or regulatory news about these therapies can affect the value of companies developing safer anticoagulants.

placebo-controlled technical

"Placebo-controlled" describes a testing method where one group receives the actual treatment or intervention, while another group receives a harmless, inactive version called a placebo. This approach helps determine whether the real treatment has genuine effects beyond psychological expectations. For investors, understanding this ensures confidence that reported benefits are real and not influenced by bias or false perceptions.

double-blind technical

A double-blind process means that neither the people conducting an activity nor the people involved know certain key details, such as who is receiving a treatment or a placebo. This approach helps prevent bias from influencing the results, making the outcome more trustworthy. For investors, it ensures that decisions or judgments are based on unbiased information rather than preconceived opinions or expectations.

parallel group technical

A parallel group is a collection of companies or entities that operate independently but share similar functions or purposes within a larger organization or industry. For investors, understanding these groups is important because they can influence overall performance, risk, and strategic decisions, much like different branches of a company that work separately but contribute to the whole. Recognizing these groups helps in assessing the stability and potential of investments across related businesses.

transient ischemic attack medical

A transient ischemic attack (TIA) is a brief episode in which blood flow to part of the brain is temporarily reduced, causing stroke-like symptoms that usually resolve within minutes to a few hours. It matters to investors because TIAs signal higher near-term risk of a full stroke, can drive demand for diagnostics, therapies and prevention products, affect healthcare costs and workforce productivity, and influence regulatory and reimbursement decisions for medical companies—think of it as a warning flicker before a potential power outage.

subgroup analysis technical

An analysis that examines how different slices of a study population—such as age groups, sex, severity of illness or other characteristics—respond to a treatment, instead of treating the whole trial group as uniform. For investors, subgroup findings can change expectations about a drug’s commercial potential, regulatory approval or label limitations by revealing who benefits most or least, much like testing a recipe in different ovens to see where it cooks best.

late-breaking technical

Late-breaking describes new, unexpected information released very close to or after scheduled events that can change how investors view a company or market. Like a last-minute play in a game that alters the score, late-breaking news can prompt quick buying or selling because it may change forecasts, risk assessments, or the value of securities almost immediately.

• Findings from OCEANIC-STROKE, including the main results and a prespecified subgroup analysis, will be presented for the first time during two late-breaking sessions at the International Stroke Conference 2026
• Asundexian is an investigational once daily, oral Factor XIa (FXIa) inhibitor

BERLIN--(BUSINESS WIRE)-- Bayer today announced that the main results from its global, landmark Phase III study OCEANIC-STROKE of asundexian in secondary stroke prevention, will be presented during two late-breaking sessions at the upcoming American Stroke Association’s International Stroke Conference (ISC) 2026. The conference will be held February 4-6 in New Orleans, Louisiana, USA.

The research to be presented demonstrates the longstanding commitment of Bayer as a leader in cardiovascular and cerebrovascular medicine, advancing innovation in thrombosis prevention.

In November 2025, Bayer announced the OCEANIC-STROKE study met its primary efficacy and safety endpoints. OCEANIC-STROKE is a multicenter, international, randomized, placebo-controlled, double-blind, parallel group and event-driven study, that enrolled over 12,300 patients.

Bayer late-breaking presentations on the Phase III study OCEANIC-STROKE at ISC 2026 include:

Late Breaker: Factor XIa Inhibition with Asundexian in Acute Non-Cardioembolic Stroke or High-Risk Transient Ischemic Attack: Primary Results of the OCEANIC-STROKE Trial

• Presenter: Mike Sharma, MD, McMaster University, Population Health Research Institute (PHRI)
• ISC invited symposium
  • Thursday, February 5, 2026; 11:15 a.m. - 11:27 a.m. CST
  • Main Event Late Breaking Science Trials, Hall D

Thursday Main Event Late-Breaking Science Trials: Q&A (Fireside Chat)

• Thursday, February 5, 2026; 2:30 p.m. - 3:30 p.m. CST
• Room 220-222

Late Breaker: Qualifying Ischemic Stroke Subtypes and Response to Asundexian: Prespecified Secondary Analysis of the OCEANIC-STROKE Trial

• Presenter: Ashkan Shoamanesh, MD, McMaster University
• Beyond the plenary: Deeper Dives into OCEANIC-STROKE, CREST-2 and FASTEST (Late-breaking Science Oral Abstract III)
  • Thursday, February 5, 2026; 3:45 p.m. - 3:55 p.m. CST
  • Main Event Late Breaking Science Trials, Hall D

To view the complete program, please visit the International Stroke Conference website.

Asundexian is an investigational agent and has not been approved by any health authority for use in any country for any indication.

About FXIa inhibitors
Factor XIa (FXIa) is a protein in the blood coagulation pathway with different roles in hemostasis and thrombosis. FXIa has a minor role in the formation of a hemostatic plug that seals the leak at the site of vessel injury. However, FXIa is thought to contribute to the formation of pathological thrombus growth and vessel blockage.

About Bayer’s Commitment in Cardiovascular and Cerebrovascular Medicines
Bayer is a leader in cardiology and is dedicated to further developing treatment options in cardiovascular (CV) diseases. We have set a clear focus on developing therapies to treat cardiovascular and cerebrovascular diseases (e.g., stroke, heart failure, cardiomyopathies, and chronic kidney disease) and it is our ambition to take a leading role in the care of patients with these diseases. Our strategy is to unlock the strong potential of the future CV market by transforming Bayer’s portfolio into precision cardiology, addressing the high CV disease burden, and driving the long-term growth. Bayer’s portfolio already includes several products and compounds in various stages of preclinical and clinical development.

About Bayer
Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. In line with its mission, “Health for all, Hunger for none,” the company’s products and services are designed to help people and the planet thrive by supporting efforts to master the major challenges presented by a growing and aging global population. Bayer is committed to driving sustainable development and generating a positive impact with its businesses. At the same time, the Group aims to increase its earning power and create value through innovation and growth. The Bayer brand stands for trust, reliability and quality throughout the world. In fiscal 2024, the Group employed around 93,000 people and had sales of 46.6 billion euros. R&D expenses amounted to 6.2 billion euros. For more information, go to www.bayer.com.

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Forward-Looking Statements
This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer’s public reports which are available on the Bayer website at www.bayer.com. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.

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Contact for global media inquiries:

Anne Jorgal, phone +49 30 2215-41592

Email: anne.jorgal@bayer.com

Contact for U.S. media inquiries:

Sarra Herzog, phone +1 862-460-8764

Email: sarra.herzog@bayer.com

Source: Bayer