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

• 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.