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Press Release Database
Recent press releases, indexed by topic.
Healthcare · Biotech & pharma
Sanofi announces decision not to submit amlitelimab in atopic dermatitis for global regulatory reviews Paris, July 24, 2026. Sanofi today announced the discontinuation of clinical development of amlitelimab, an OX40-ligand monoclonal antibody, in moderate-to-severe atopic dermatitis (AD). This decision not to submit for global regulatory reviews was made as part of an ongoing strategic assessment of the pipeline. San
Jul 24 · 12:51·Sanofi
Biotech & pharma
VOGUE is the first head-to-head, randomised daily orals study comparing 2-drug regimen Dovato with 3-drug regimen Biktarvy
Jul 21 · 10:28·GSK
Finance · Healthcare
GSK plc (LSE/NYSE: GSK) today provides an update on the CALM-1 and CALM-2 phase III clinical trials
Jul 17 · 09:00·GSK
Finance · Healthcare
GSK plc today announced completion of its acquisition of Nuvalent, Inc. , a Boston-based clinical-stage biopharmaceutical company.
Jul 15 · 13:40·GSK
Healthcare · Biotech & pharma
ARTEMIS-008 met its primary endpoint of overall survival in advanced or relapsed small-cell lung cancer
Jul 10 · 11:00·GSK
Biotech & pharma
Case studies These 10 case studies showcase representative questions from GeneBench-Pro. Each case study includes the original prompt, datasets, and supporting materials. For an overview of the benchmark and key findings, see the announcement blog . Note: File previews show excerpts from the full datasets. Case study 1 Somatic oncology: Structural variant-guided tumor therapy benefit-risk decision Estimate whether a
Jun 30 · 00:00·OpenAI
Biotech & pharma
Bristol Myers Squibb (BMS), a leading global biopharmaceutical company, has appointed Mayada Al-Ahmad to the position of General Manager of Saudi...
Jun 17 · 14:23·Bristol Myers Squibb
AI · Biotech & pharma
OpenAI and Molecule.one show how a near-autonomous AI chemist using GPT-5.4 improved a key drug-making reaction, advancing medicinal chemistry research.
Jun 17 · 10:00·OpenAI
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
Biotech & pharma
VEXAS syndrome is a rare, life-threatening haemato-inflammatory condition with no approved treatments.
Jun 12 · 12:00·GSK
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