Bayer Granted Priority Review by U.S. FDA for Asundexian in Patients After a Non-Cardioembolic Ischemic Stroke or Transient Ischemic Attack

Key Terms

priority review regulatory

Priority review is a regulatory fast-track that shortens the time an agency spends evaluating a drug, vaccine or medical device application so a decision comes sooner than normal. For investors, it matters because a faster review is like an express lane to market: it can speed revenue potential and reduce regulatory uncertainty, but it does not guarantee approval and still requires the product to meet safety and effectiveness standards.

new drug application regulatory

A new drug application is a formal request submitted to government regulators seeking approval to market a new medicine. It is like a detailed proposal that shows the drug has been tested for safety and effectiveness. For investors, receiving approval signals that the drug may soon become available for sale, potentially leading to revenue growth and impacting the company's value.

factor xia (fxia) inhibitor medical

A factor XIa (FXIa) inhibitor is a type of drug that blocks a specific protein in the blood-clotting chain, lowering the blood’s tendency to form harmful clots while aiming to preserve normal clotting for injuries. For investors, these drugs matter because they target a large market for stroke, heart attack and surgical clot prevention with the promise of fewer bleeding side effects than existing anticoagulants—so trial results, safety data and regulatory decisions can strongly affect a developer’s value.

ischemic stroke medical

An ischemic stroke occurs when a blood vessel supplying the brain is blocked, cutting off oxygen and nutrients to part of the brain — like a kinked garden hose that stops water flow. It matters to investors because its incidence and outcomes drive demand for drugs, emergency devices, diagnostic tools, rehabilitation services and clinical trials; changes in treatment effectiveness, approvals or costs can materially affect healthcare companies and insurers.

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.

phase iii medical

A Phase III trial is the late-stage clinical study that tests whether a medical treatment works and is safe in a large group of patients, often comparing it to standard care. Think of it as a final dress rehearsal or full-scale road test before regulators decide on approval; positive or negative results strongly influence a drug maker’s chance to sell the treatment, future revenue, and investment risk.

isth major bleeding medical

ISTH major bleeding is a standardized clinical definition, set by the International Society on Thrombosis and Haemostasis, that identifies serious bleeding events in patients taking blood-thinning drugs or undergoing related treatments. It matters to investors because it is a key safety endpoint in drug and device trials—think of it as a scoreboard for dangerous side effects—which regulators, doctors and markets use to judge a therapy’s risk profile and commercial prospects.

fast track designation regulatory

Fast track designation is a status the U.S. Food and Drug Administration grants to drugs intended to treat serious conditions and address an unmet medical need. It gives the developer more frequent communication with the FDA and can allow parts of the application to be reviewed on a rolling basis, and it may pave the way to priority review or accelerated approval. It can shorten development timelines, though it does not guarantee approval.

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KEY FACTS:

• Regulatory submission is based on positive results from the Phase III OCEANIC-STROKE study
• OCEANIC-STROKE met the primary efficacy outcome of time to first occurrence of ischemic stroke and the primary safety outcome of time to ISTH (International Society on Thrombosis and Haemostasis) major bleeding

WHIPPANY, N.J.--(BUSINESS WIRE)-- Bayer:

WHAT’S HAPPENING

Bayer today announced that the U.S. Food and Drug Administration (FDA) has accepted the company’s New Drug Application (NDA) and granted Priority Review designation for its investigational oral Factor XIa (FXIa) inhibitor, asundexian, for the prevention of secondary stroke in patients following a non-cardioembolic ischemic stroke or transient ischemic attack (TIA). The NDA is based on positive results from the global, pivotal Phase III OCEANIC-STROKE trial. The study results were presented at the International Stroke Conference 2026 in New Orleans and published in The New England Journal of Medicine.

BAYER EXECUTIVE COMMENT

“Secondary stroke remains a serious and persistent challenge, and the FDA’s Priority Review designation underscores the urgency of advancing potential new approaches in secondary stroke prevention,” said Yesmean Wahdan, M.D., Senior Vice President, U.S. Medical Affairs, Bayer. “We are proud of this important milestone that builds on our long-standing commitment to innovation in anti-thrombotic therapies and look forward to collaborating with the FDA as we work to bring asundexian to patients in need.”

In 2023, asundexian was granted Fast Track Designation by the FDA as a potential treatment for stroke prevention in patients after a non-cardioembolic ischemic stroke. The FDA has now granted Priority Review for asundexian, a designation for the evaluation of medicines that, if approved, would provide a significant improvement in the safety or effectiveness of the treatment, prevention, or diagnosis of a serious condition.¹

WHY THIS MATTERS

Stroke is the fifth leading cause of death in the United States.² Each year, approximately 795,000 people in the United States will experience a stroke. Of these, approximately 87% are ischemic and 23% are recurrent.³ Despite current guideline recommendations for stroke prevention, a significant proportion of survivors experience another stroke.^4,5 Approximately one in five stroke survivors will have another stroke within five years.⁵

About FXIa
Factor XIa (FXIa) is a protein in the blood coagulation pathway, also known as the blood clotting process, with different roles in hemostasis (normal clotting to stop bleeding) and thrombosis (harmful clot formation that can block blood vessels). FXIa has a minor role in the formation of a hemostatic plug (a clot that seals a blood vessel injury) that seals the leak at the site of vessel injury. However, FXIa is thought to contribute to the formation of pathological thrombus growth (abnormal clot growth) and vessel blockage.

About Bayer’s Commitment in Cardiovascular and Cerebrovascular Medicine
Bayer is a leader in cardiology and is advancing a portfolio of innovative treatments in cardiovascular (CV) and cerebrovascular diseases of high unmet medical need. We have set a clear focus on developing innovative therapies to treat such 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. Bayer is actively shaping the future of cardiology and neurology with a robust and diversified pipeline, strategically positioned to address critical unmet needs and drive significant long-term value. Bayer’s portfolio already includes several innovative 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 2025, the Group employed around 88,000 people and had sales of 45.6 billion euros. R&D expenses amounted to 5.8 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.

References:

1. U.S. Food and Drug Administration. “Priority Review.” https://www.fda.gov/patients/fast-track-breakthrough-therapy-accelerated-approval-priority-review/priority-review
2. Martin SS, et al. Circulation. 2024;149(8):e347–e913.
3. Virani SS, et al. Circulation. 2021;143:e254–e743
4. Kolmos M, et al. J Stroke Cerebrovasc Dis. 2021;30(8):105935.
5. Lakshminarayan K, et al. Stroke. 2011;42(6):1556–1562.

View source version on businesswire.com: https://www.businesswire.com/news/home/20260518787299/en/

Contact for U.S. media inquiries:
Sarra Herzog, phone +1 862-460-8764
Email: sarra.herzog@bayer.com

Contact for investor inquiries:
Bayer Investor Relations Team, phone +49 214 30-72704
Email: ir@bayer.com
www.bayer.com/en/investors/ir-team

Source: Bayer