SaaS · Healthcare
Leverkusen, June 25, 2026 – The U.S. Supreme Court issued a 7:2 landmark ruling in the Durnell Roundup™ case on Thursday, affirming that the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) expressly preempts state-law-based failure-to-warn claims when the U.S. Environmental Protection Agency (EPA) has made a definitive determination on product safety. This decision, which reflects strong support across the ideological spectrum of the Court, helps to bring significant containment to the Roundup™ litigation. Glyphosate remains the most studied crop protection tool in the world and this decision affirms that the EPA’s safety determination is the law of the land, ensuring that companies cannot be punished under a patchwork of state tort laws for complying with federal labeling requirements.
“This decision is good for American farmers who help feed the world. It provides the regulatory clarity necessary for innovators like us to develop the agricultural tools that guarantee an affordable food supply,” said Bayer CEO Bill Anderson. "This litigation has enormous costs for the company and has impacted public trust. The decision brings overdue justice on an issue that should have been clarified much earlier. It’s time to put it behind us. Strengthened by this ruling, we continue to pursue our multi-pronged containment strategy, which includes the previously announced class settlement.”
The majority opinion states: “Durnell’s state law failure-to-warn claim would require a cancer warning on Roundup’s label — a requirement ‘in addition to’ and ‘different from’ the label required by EPA under FIFRA. FIFRA therefore expressly preempts Durnell’s claim.”
Impact of the Ruling
The holding in Durnell should result in the dismissal of current warnings-based claims and foreclose future claims based on state-failure-to-warn theories, which make up the vast majority of claims in the litigation to date.
In February 2026, along with class counsel, Monsanto announced a proposed U.S. nationwide class settlement designed to resolve current and future Roundup™ claims alleging non-Hodgkin lymphoma injuries through a long-term compensation program. Monsanto previously explained that the class settlement and Supreme Court strategies were independently necessary and mutually reinforcing elements of the company’s multi-pronged containment strategy. Together with today’s positive ruling, the class – which has received preliminary approval – will help ensure that Monsanto can significantly contain this litigation.
Good for farmers, food security, and American consumers
For years, American farmers have operated under a cloud of legal uncertainty created not by science, but by the litigation industry. Glyphosate-based herbicides are a foundation of modern, sustainable agriculture. Their safe and effective use supports food security, keeps production costs affordable, makes no-till, sustainable farm practices possible, and allows farmers to do more with less. This ruling restores the regulatory clarity that the agricultural sector, the broader food supply chain, and American consumers deserve after nearly a decade of well-funded attacks by the plaintiffs’ bar. It also provides an opportunity to restore public trust in the scientific consensus on the safety of glyphosate-based herbicides. The studies reviewed by regulatory authorities on glyphosate’s safety in connection with recent registration reviews are publicly available at www.bayer.com/en/glyphosate-studies
Court clarifies law that supports science
The EPA has repeatedly and unequivocally determined that glyphosate is not likely to be carcinogenic. Every leading independent regulatory body worldwide that has conducted its own review of glyphosate safety — from the European Food Safety Authority to regulators across Asia and Latin America — has reached the same conclusion. This is not the judgment of any single agency or administration; it is the settled consensus of the world's foremost scientific experts.
What has challenged this consensus is not new evidence — instead, it is largely a single, decade-old report from the International Agency for Research on Cancer (IARC) used in courtrooms by plaintiffs’ attorneys, despite the fact that every leading regulator in the world that has examined IARC’s report disagrees with its conclusions. Allowing this outlier report to override the expert determinations of federal regulatory agencies and scientists, despite the express uniformity requirements of federal law, has led to a patchwork of jury-by-jury requirements and uncertainties for manufacturers, farmers, and consumers alike. This decision restores the integrity of the scientific regulatory process and the independence of the experts within it.
The long road to this moment
This litigation has spanned years, consumed enormous resources, and distracted from what the company does best — promoting Health for all, Hunger for none. Many billions have been directed toward the Roundup™ litigation — money that could have funded the next generation of sustainable crop protection tools, breakthrough therapies, or other advances that farmers, consumers, and patients urgently need. These litigation costs diminish investments in innovation and are borne not just by the company, but by every patient waiting for a new therapy, every farmer waiting for a better tool, and every shareholder whose capital was diverted. Today marks the beginning of a new chapter in Health for all, Hunger for none.
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.
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.
Bayer AG is a holding company with operating subsidiaries worldwide. References to “Bayer” or “the company” herein may refer to one or more subsidiaries as context requires.
Jun 25 · 15:41·Bayer
Healthcare · Sustainability
Leverkusen, June 17, 2026 – On Wednesday, Judge Henry E. Autrey, a federal district court judge in the Eastern District of Missouri, issued a ruling remanding the class settlement case, King v Monsanto, back to Missouri State Court. Monsanto released the following statement in response to the Court’s decision:
This decision returns jurisdiction over the class settlement to Missouri Circuit Court where the vast majority of pending claims in the Roundup™ litigation have been filed. This decision brings much needed clarity to all parties and will enable the class approval process to continue to move forward. It also renders the related JPML proceedings moot, as this Court has determined the case belongs in state, rather than federal court.
Monsanto remains confident that the class settlement, which is supported by plaintiffs’ counsel representing tens of thousands of potential class members, is fair to all parties and the objections have no merit.
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.
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.
Bayer AG is a holding company with operating subsidiaries worldwide. References to “Bayer” or “the company” herein may refer to one or more subsidiaries as context requires.
Jun 17 · 16:05·Bayer
Finance · SaaS
Berlin, Germany, June 17, 2026 – Bayer today announced the completion of the acquisition of Perfuse Therapeutics, Inc. As a result, Perfuse Therapeutics will now be fully integrated into Bayer. As announced previously, Bayer now holds the full rights pertaining to PER-001 intravitreal implant, a first in class, sustained release small molecule endothelin receptor antagonist currently in Phase II clinical development for the treatment of Glaucoma and Diabetic Retinopathy (DR).
This acquisition strengthens Bayer’s pharmaceutical pipeline and strategically fits with Bayer’s strong footprint and expertise in ophthalmology.
Under the terms of the agreement, Bayer paid an upfront payment of USD 300 million. The transaction carries a total potential value of up to USD 2.45 billion, comprising of the upfront payment and additional success-based milestone payments.
For Bayer, BofA Securities acted as exclusive financial advisor and Baker McKenzie acted as legal counsel. For Perfuse, Centerview Partners LLC acted as exclusive financial advisor and Goodwin Procter LLP acted as legal counsel.
About Perfuse Therapeutics
Perfuse Therapeutics is a biopharmaceutical company pioneering transformational research into the treatment of ischemia-induced ocular diseases. Enabled by its proprietary sustained-release drug delivery platform, the company is advancing its lead asset PER-001 for global leading causes of blindness. Headquartered in South San Francisco, Calif., and with R&D facilities in Durham, N.C., Perfuse Therapeutics has established a strong team committed to advancing disease-modifying therapies to patients with ocular disease around the world.
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.
Find more information at https://pharma.bayer.com/
Follow us on Facebook: http://www.facebook.com/bayer
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.
Bayer AG is a holding company with operating subsidiaries worldwide. References to “Bayer” or “the company” herein may refer to one or more subsidiaries as context requires.
Contact for media inquiries:
Lisa Varrelmann, phone: +49 1746466492
Email: lisa.varrelmann@bayer.com
Contact for investor inquiries:'
Bayer Investor Relations Team, phone +49 214 30-72704
Email: ir@bayer.com'
www.bayer.com/de/investoren/ir-team
Jun 17 · 06:30·Bayer
Healthcare · Media
Not intended for U.S. and UK Media
Bayer’s low-dose MRI contrast agent gadoquatrane approved in U.S.
Gadoquatrane from Bayer receives FDA approval for contrast-enhanced MRI to detect and visualize lesions with abnormal vascularity in the central nervous system and non-CNS body regions / Gadoquatrane becomes the lowest-dose macrocyclic gadolinium (Gd)-based contrast agent (mGBCA) approved in the U.S., with a recommended dose of 0.01 mmol/kg actual body weight, corresponding to 0.04 mmol Gd/kg body weight / Approval is supported by data from the Phase III QUANTI clinical studies, which demonstrated efficacy at a fraction of the dose compared to mGBCAs dosed at 0.1 mmol Gd/kg body weight / Gadoquatrane received its first approval in Japan in March 2026, further submissions to health authorities worldwide are ongoing to secure marketing authorization in additional markets
Berlin, June 15, 2026 – Bayer today announced that the U.S. Food and Drug Administration (FDA) approved gadoquatrane, a new, intravenous macrocyclic gadolinium (Gd)-based contrast agent (mGBCA) under the brand name Ambelvist™. The product is indicated for contrast-enhanced magnetic resonance imaging (MRI) to detect and visualize lesions with abnormal vascularity in the central nervous system (CNS) and non-CNS body regions in adult and pediatric patients, including term neonates. Gadoquatrane is a next-generation mGBCA with a novel tetrameric structure and high relaxivity (a measure of signal enhancement).
With this approval, gadoquatrane becomes the lowest dose mGBCA in the U.S. It has a recommended dose of 0.01 mmol/kg actual body weight (which corresponds to 0.04 mmol Gd/kg body weight), representing 60% less Gd compared to mGBCAs with a Gd content of 0.1 mmol Gd/kg body weight and 20% less Gd compared to gadopiclenol dosed at 0.05 mmol Gd/kg body weight.
There is a rising need for medical imaging, driven by the increasing incidence of chronic diseases such as cancer and cardiovascular diseases. Contrast-enhanced MRI is a medical imaging examination often used by clinicians to gain insight into what’s happening in the human body and can play an important role in detecting abnormalities, monitoring disease progression and informing treatment decisions. For some adults and children with chronic diseases or conditions that require close, long-term monitoring – such as multiple sclerosis, other neurological or spinal conditions as well as different types of cancer – regular, repeat administrations may be required.
“I often rely on contrast-enhanced MRI exams to inform clinical decision making,” said Dr. Christopher Hancock, Director of Neuroradiology at HALO Diagnostics Desert Cities, USA, and an investigator for the QUANTI clinical studies. “With this approval, we now have an additional option that can help deliver contrast-enhanced images at the lowest macrocyclic GBCA dose, reducing gadolinium exposure while preserving the clinical information we often need.”
“Bayer is a leader in radiology and has played a pioneering role in MRI contrast agent development, having launched the first gadolinium-based contrast agent in 1988,” said Dr. Konstanze Diefenbach, Head of Radiology R&D at Bayer’s Pharmaceuticals Division. “With gadoquatrane – a next generation high-relaxivity, low-dose MRI contrast agent demonstrating high stability – we continue driving advances for patients and their treating physicians. Reducing patients’ lifetime exposure to gadolinium is an important consideration and reflects the growing clinical guidance to use the lowest gadolinium dose necessary to adequately image patients.”
Gadoquatrane received its first approval in Japan in March 2026, and Bayer has submitted applications for marketing authorization in additional markets around the world, including the EU and China, with more to follow.
Key Clinical Trial Findings
The FDA’s approval is based on the global pivotal Phase III QUANTI clinical studies, which evaluated the efficacy and safety of gadoquatrane in adult and pediatric patients, including term neonates, undergoing contrast-enhanced MRI. Key findings demonstrated:
· Increased lesion visualization with the combined pre-contrast and post-contrast MRI sets with the decreased Gd dose in gadoquatrane compared with only pre-contrast MRI images.
· Visualization scores and number of lesions identified per blinded independent reader for gadoquatrane dosed at 0.01 mmol/kg body weight (which corresponds to 0.04 mmol Gd/kg body weight) were similar to mGBCAs with a Gd content of 0.1 mmol Gd/kg body weight.
· Use in children is supported by evidence from adequate and well-controlled studies of gadoquatrane in adults, with additional pharmacokinetic and safety data from the pediatric study, including 93 patients aged 28 days to less than 18 years who received one 0.01mmol/kg dose and underwent MRI of any body region.
About gadoquatrane
Gadoquatrane is Bayer’s extracellular macrocyclic contrast agent for contrast enhancement in MRI. This low-dose gadolinium-based contrast agent features a distinct tetrameric structure with high stability and high relaxivity.
The compound has been approved under the brand name Ambelvist™ in Japan in March 2026 and in the U.S. in June 2026. It has not been approved in any other jurisdiction. Bayer has submitted applications for marketing authorization of gadoquatrane in additional markets around the world.
About MRI
MRI is a non-invasive, radiation-free imaging method that provides detailed images of the body, helping to identify and distinguish potential abnormalities in organs and tissues. This supports physicians in answering critical medical questions related to the detection and monitoring of diseases. MRI contrast agents commonly contain gadolinium. For 2024, it is estimated that over 60 million doses of gadolinium-based contrast agents were administered worldwide. Cumulatively, since 1988, more than 900 million GBCA doses have been delivered globally.
About Radiology at Bayer
Building on a century of expertise, Bayer is committed to innovative products and high-quality services in diagnostic imaging to enhance patient care. Its leading radiology portfolio features contrast agents and devices for precise administration across modalities including computed tomography (CT), X-ray and magnetic resonance imaging (MRI), and positron emission tomography (PET). Bayer’s comprehensive offerings also include informatics solutions. In 2025, Bayer’s radiology products generated €2.2 billion in sales. Bayer continues to advance research and innovation in medical imaging, including in molecular imaging and other promising fields.
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.
Find more information at https://pharma.bayer.com/
Follow us on Facebook: http://www.facebook.com/bayer
Follow us on Twitter: @BayerPharma
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.
Bayer AG is a holding company with operating subsidiaries worldwide. References to “Bayer” or “the company” herein may refer to one or more subsidiaries as context requires.
Global contact for media inquiries:
Victoria Vigener, phone +49 151 23438911
Email: victoria.vigener@bayer.com
US contact for media inquiries:
Elaine Colon, phone +1-732-236-1587
Email: elaine.colon@bayer.com
Contact for investor inquiries:
Bayer Investor Relations Team, phone +49 214 30-72704
Email: ir@bayer.com
www.bayer.com/de/investoren/ir-team
Jun 15 · 06:30·Bayer
Healthcare · Food & drink
Not intended for U.S. and UK Media
European Medicines Agency confirms asundexian marketing authorization application for assessment in secondary prevention of ischemic stroke
This application for asundexian is the first marketing authorization application submission of a Factor XIa (FXIa) inhibitor in Europe and is based on positive data from the pivotal, global Phase III OCEANIC-STROKE study / With increasing prevalence of ischemic stroke and stroke-related mortality, stroke is the second leading cause of death in Europe
Berlin, June 10, 2026 – Bayer today announced that the European Medicines Agency (EMA) has positively validated and begun assessing the company’s marketing authorization application for asundexian, an oral Factor XIa (FXIa) inhibitor, in the prevention of ischemic stroke in adults after a non-cardioembolic ischemic stroke or a high-risk transient ischemic attack (TIA).
Validation of the application confirms the submission is complete and begins the EMA’s centralized review procedure.
Stroke is a growing public health issue, affecting around 10 million people in Europe who are living with the consequences of stroke and more than one million people who are newly impacted each year. Globally, and in Europe, stroke is the second leading cause of death, resulting in a significant burden on healthcare systems with estimated global costs reaching 891 billion US-Dollar annually.
“Between 2010 and 2019, the prevalence of ischemic stroke and stroke-related mortality increased by 4 percent and 7 percent, respectively, across EU member states underscoring the growing burden of this disease,” said Christian Rommel, Ph.D., Global Head of Research and Development at Bayer`s Pharmaceuticals Division. “The acceptance of our marketing authorization application by the EMA is a testament to our unwavering commitment to offering patients in need novel treatment options.”
Bayer is continuing to submit applications for marketing authorization for asundexian to other health authorities globally. China’s Center of Drug Evaluation and the U.S. Food and Drug Administration (FDA) have recently granted asundexian Priority Review designation.
About OCEANIC-STROKE
The Phase III OCEANIC-STROKE study 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. It is a multicenter, international, randomized, placebo-controlled, double-blind, parallel group and event-driven study, that randomized 12,327 participants worldwide. The primary efficacy endpoint was time to ischemic stroke; the primary safety endpoint was ISTH major bleeding. The full results from OCEANIC-STROKE have been published in The New England Journal of Medicine.
The application to the European Medicines Agency is based on positive data from the Phase III OCEANIC-STROKE study. The study found that asundexian 50 mg, significantly reduced ischemic stroke by 26 percent in patients after a non-cardioembolic ischemic stroke or high-risk TIA compared to placebo, both in combination with antiplatelet therapy, with no increase in ISTH (International Society on Thrombosis and Hemostasis) major bleeding.
About FXIa Inhibitors and Asundexian
Factor XIa (FXIa) is a protein in the blood coagulation pathway with different roles in hemostasis and thrombosis. FXIa is thought to contribute to the formation of pathological thrombus growth and vessel blockage. However, FXIa has a minor role in the formation of a hemostatic plug that seals the leak at the site of vessel injury.
Asundexian is an investigational compound and has not been approved by any health authority for use in any country for any indication.
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. The company has set a clear focus on developing 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.
Find more information at https://pharma.bayer.com
Follow us on Facebook: http://www.facebook.com/bayer
Follow us on LinkedIn: Bayer | Pharmaceuticals
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.
Bayer AG is a holding company with operating subsidiaries worldwide. References to “Bayer” or “the company” herein may refer to one or more subsidiaries as context requires.
Jun 10 · 06:29·Bayer
Automotive · Education
In conjunction with the Ministry of Sustainability and the Environment’s (MSE) Go Green SG 2026, Hackathon was hosted by HMGICS and Hyundai CRADLE Singapore in partnership with Temasek Foundation, with support from the National University of Singapore (NUS)
Fifth edition rallied the largest cohort of 91 students from nine local and international schools to date to co-create climate adaptation solutions in support of the Year of Climate Adaptation
HMGICS and Hyundai CRADLE Singapore are committed to growing alongside Singapore by empowering and nurturing future-ready youths through their annual CSR Hackathon programme
Jun 4 · 09:00·Hyundai Motor Company
Healthcare · Food & drink
Berlin, May 19, 2026 – Bayer today announced that the U.S. Food and Drug Administration (FDA) and Japan’s Ministry of Health, Labour and Welfare have accepted the company’s New Drug Applications (NDA) for its investigational Factor XIa (FXIa) inhibitor, asundexian, for the prevention of ischemic stroke in patients after a non-cardioembolic ischemic stroke or transient ischemic attack (TIA). In addition, the U.S. FDA granted asundexian Priority Review designation.
Approximately 12 million people experience a stroke every year.3 Of those who survive a stroke, approximately 1 in 10 will have another stroke within 1 year, even with available secondary stroke prevention strategies.1
“The acceptances of submissions in key markets represent another milestone in the development of asundexian and in our commitment to secondary stroke care. More than 90 million people worldwide are living with the consequences of a stroke, highlighting its significant impact on public health,” said Christian Rommel, Ph.D., Head of Research and Development at Bayer`s Pharmaceuticals Division. “We are collaborating with health authorities to advance the approval process.”
Bayer is continuing to submit applications for marketing authorization for asundexian to other health authorities globally. China’s Center of Drug Evaluation has also recently accepted Bayer’s marketing authorization application for asundexian and granted it Priority Review designation.
About OCEANIC-STROKE
The Phase III OCEANIC-STROKE study 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. It is a multicenter, international, randomized, placebo-controlled, double-blind, parallel group and event-driven study, that randomized 12,327 participants worldwide. The primary efficacy endpoint was time to ischemic stroke; the primary safety endpoint was ISTH major bleeding. The full results from OCEANIC-STROKE have recently been published in The New England Journal of Medicine.
The applications to the U.S. FDA and to Japan’s Ministry of Health, Labour and Welfare are based on positive data from the Phase III OCEANIC-STROKE study. The study found that asundexian 50 mg, significantly reduced ischemic stroke by 26 percent in patients after a non-cardioembolic ischemic stroke or high-risk TIA compared to placebo, both in combination with antiplatelet therapy, with no increase in ISTH (International Society on Thrombosis and Hemostasis) major bleeding.
About FXIa Inhibitors and Asundexian
Factor XIa (FXIa) is a protein in the blood coagulation pathway with different roles in hemostasis and thrombosis. FXIa is thought to contribute to the formation of pathological thrombus growth and vessel blockage. However, FXIa has a minor role in the formation of a hemostatic plug that seals the leak at the site of vessel injury.
Asundexian is an investigational compound and has not been approved by any health authority for use in any country for any indication.
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. The company has set a clear focus on developing 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.
Find more information at https://pharma.bayer.com
Follow us on Facebook: http://www.facebook.com/bayer
Follow us on LinkedIn: Bayer | Pharmaceuticals
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.
Bayer AG is a holding company with operating subsidiaries worldwide. References to “Bayer” or “the company” herein may refer to one or more subsidiaries as context requires.
1 Kolmos M, Christoffersen L, Kruuse C. Recurrent Ischemic Stroke – A Systematic Review and Meta-Analysis. J Stroke Cerebrovasc Dis. 2021;30(8):105935.
2 U.S. Food and Drug Administration. Priority Review. 2018. Available at: https://www.fda.gov/patients/fast-track-breakthrough-therapy-accelerated-approval-priority-review/priority-review. Last accessed: May 2026.
3 Feigin VL, et al. World Stroke Organization (WSO): Global Stroke Fact Sheet 2022. Int J Stroke. 2022;17(1):18-29.
May 19 · 06:29·Bayer
Sustainability
Hyundai Motor Group and partners in Hong Kong sign agreement at International Hydrogen Development Symposium 2026 to accelerate development of Hong Kong’s hydrogen ecosystem
The Group to leverage waste-to-hydrogen (W2H) model, building on expertise from Korean and Indonesian markets
Plan includes local production of low-carbon hydrogen, development and operation of liquid hydrogen refueling stations and deployment of hydrogen-powered commercial vehicles
Partnership creates a launchpad for hydrogen business expansion across the Asia-Pacific region
May 18 · 07:30·Hyundai Motor Company
Sustainability
Climate tech will be the catalyst for the future of the net zero transition – and Asia will be at the heart of this, says Julian Wentzel.
Other
May 15 · 00:00·HSBC
Sustainability
Hyundai Motor ranked No. 1 overall in the Asia Auto & Auto Parts sector in the 2026 Extel Asia Executive Team survey
Company leadership, including the CEO, CFO, IR Professional and categories including corporate management, IR program, ESG and Board of Directors all received top rankings
Accolades reflect strong investor confidence in the company’s management, credibility and strategic capital allocation
May 13 · 23:30·Hyundai Motor Company
Finance · SaaS
Berlin, Germany and San Francisco, California USA, May 6, 2026 – Bayer and Perfuse Therapeutics Inc. today announced an agreement under which Bayer will fully acquire Perfuse Therapeutics, a biopharmaceutical company pioneering transformational research into the treatment of ischemia-induced ocular diseases. With this acquisition, Bayer will hold the full rights pertaining to PER-001, a small molecule endothelin receptor antagonist currently in Phase II clinical development for the treatment of Glaucoma and Diabetic Retinopathy (DR).
This represents one of the first potential treatments for Glaucoma and DR being studied for its ability to improve the visual field for Glaucoma patients and to improve contrast sensitivity and reduce ischemia in DR patients.
“We are excited by the work of the team at Perfuse Therapeutics and encouraged by the potential of PER-001,” said Juergen Eckhardt, M.D., Head of Business Development and Licensing at Bayer Pharmaceuticals. “With this acquisition, we are complementing our expertise in ophthalmology and our pipeline, reinforcing our commitment to developing urgently needed therapies for patients.”
“I’m incredibly proud of what the Perfuse team has accomplished and deeply thankful to all our investors and collaborators," said Sevgi Gurkan, MD, Founder and CEO of Perfuse Therapeutics, Inc. "Bayer’s vision aligns closely with ours, and they have the scale and global resources to unlock the full potential of PER-001 to change the trajectory of human blindness. We are very excited to see our mission continue with even greater momentum.”
Glaucoma is a progressive optic neuropathy that causes the loss of retinal ganglion cells, resulting in loss of visual fields. It is the leading cause of irreversible vision loss1 affecting ~76-80 million people worldwide (2020) and is projected to affect ~112 million people by 2040 due to population aging.2 Despite its prevalence, there are no approved treatments today, preventing disease progression and blindness independently from the saturated approach of lowering intraocular pressure. There is a high unmet medical need for neuroprotective treatments for patients with Glaucoma.
Diabetic Retinopathy (DR) is a microvascular complication of diabetes that damages retinal capillaries, causing ischemia, leakage, and neovascularization affecting about 146 million people globally today. This includes about 25 percent of adults with diabetes and is projected to increase to 160 million people by 2045. Currently, 25 million people have vision‑threatening DR and 1.3 million people are blind.3
Under the terms of the agreement, the transaction carries a total potential value of up to USD 2.45 billion, comprising a USD 300 million upfront payment and additional development, regulatory, and commercial milestone payments based on success criteria.
For Bayer, BofA Securities is acting as exclusive financial advisor and Baker McKenzie is acting as legal counsel. For Perfuse, Centerview Partners LLC is acting as exclusive financial advisor and Goodwin Procter LLP is acting as legal counsel.
The acquisition is subject to and will become effective after receiving the necessary antitrust clearances and Perfuse stockholder approvals.
About PER-001
PER-001 is an investigational small molecule endothelin receptor antagonist being developed for the treatment of ophthalmic diseases. Endothelin is the most potent vasoconstrictor in the human body and is upregulated in glaucoma, diabetic retinopathy, age-related macular degeneration and retinal vein occlusion. Endothelin is involved in inflammation and cell death through its receptors expressed in retinal vascular and neuroretinal cells. The PER-001 intravitreal implant is a bio-erodible implant administered into the vitreous cavity of the eye using a single-use, 25-gauge applicator and designed to provide a sustained release of PER-001, allowing for a convenient dosing regimen.
About Perfuse Therapeutics
Perfuse Therapeutics is a biopharmaceutical company pioneering transformational research into the treatment of ischemia-induced ocular diseases. Enabled by its proprietary sustained-release drug delivery platform, the company is advancing its lead asset PER-001 for global leading causes of blindness. Headquartered in South San Francisco, Calif., and with R&D facilities in Durham, N.C., Perfuse Therapeutics has established a strong team committed to advancing disease-modifying therapies to patients with ocular disease around the world. For more information, visit www.perfusetherapeutics.com and LinkedIn.
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.
Find more information at https://pharma.bayer.com
Follow us on Facebook: http://www.facebook.com/bayer
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.
Bayer AG is a holding company with operating subsidiaries worldwide. References to “Bayer” or “the company” herein may refer to one or more subsidiaries as context requires.
1 Vision Loss Expert Group of the Global Burden of Disease, 2024, Eye
² Sarkis et al., 2025, Frontiers in Med
³ WHO, 2019, World report on vision Executive Summary
Bayer Global Media Contact:
Lisa Varrelmann, phone +49 1746466492
Email: lisa.varrelmann@bayer.com
Contact for investor inquiries:
Bayer Investor Relations Team,
phone +49 214 30-72704
Email: ir@bayer.com
www.bayer.com/de/investoren/ir-team
Perfuse Therapeutics Media Contact:
Perfuse Therapeutics Team
Email: info@perfusetherapeutics.com
Perfuse Therapeutics investor inquiries:
Perfuse Therapeutics Team
Email: info@perfusetherapeutics.com
May 6 · 06:30·Bayer
Energy · Automotive
Hyundai Motor Group announces a multi-year partnership on hydrogen mobility solutions with the Georgia Institute of Technology
Partnership includes Hyundai Motor North America donating four NEXO fuel cell electric SUVs and Hyundai Motor Group donating a hydrogen electrolyzer project exclusively for campus use
New initiative brings NEXO hydrogen fuel cell SUVs and fueling infrastructure to campus, advancing research, workforce development, and zero-emissions logistics
The NEXO SUVs will support both campus operations and interdisciplinary research across engineering, sustainability, energy systems, and public policy
Apr 29 · 16:40·Hyundai Motor Company