Presentations include investigational late-breaking KERENDIA® (finerenone) data in chronic kidney disease (CKD), including a pooled analysis from studies in patients with and without diabetes and a subanalysis in patients with CKD without diabetes, and for iodine 124 evuzamitide (I 124 evuzamitide) from a Phase III study in patients with suspected cardiac amyloidosis.

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

Summary

Bayer today announced that 11 oral presentations across its cardiovascular, kidney, and secondary stroke prevention programs will be featured at the European Society of Cardiology (ESC) Congress 2026 in Munich, Germany, from August 28-31, 2026.

Key Facts

• Data from two late-breaking presentations will be featured, including a pre-specified subgroup analysis from the Phase III FIND-CKD trial, which evaluated KERENDIA® (finerenone) in patients with CKD without diabetes and hypertensive nephropathy, and data from the INFINITY pooled analysis evaluating the efficacy and safety of KERENDIA in patients with chronic kidney disease (CKD) with and without a history of atherosclerotic cardiovascular disease (ASCVD). Additional subanalysis data will also be presented for KERENDIA in people living with heart failure (HF) with left ventricular ejection fraction (LVEF) ≥ 40%.
• KERENDIA is currently approved by the FDA for use in adults with CKD associated with type 2 diabetes (T2D), as well as adults with HF with LVEF ≥40%.
• Full results from the Phase III REVEAL study, which evaluated the investigational PET radiotracer I 124 evuzamitide for the sensitivity and specificity of cardiac amyloidosis based on visual scan interpretation, will be shared for the first time.
• A new analysis from the previously presented Phase III OCEANIC-STROKE trial will explore how participant characteristics affected their response to asundexian in secondary stroke prevention.

Why This Matters

“Bayer is committed to further researching and providing resources to support prevention, early diagnosis, and management for people with heart and kidney conditions, as well as stroke. These data reflect Bayer’s commitment to that cause,” said Robert Perkins, MD, Vice President, US Medical Affairs. "We look forward to advancing the scientific dialogue across the spectrum of cardiovascular and cerebrovascular disease care."

BAYER PRESENTATIONS AT ESC 2026:

Cardiac Amyloidosis

• A phase 3, open-label, multicenter study of investigational positron emission tomography (PET) radiotracer iodine 124 evuzamitide in the assessment of patients with suspected cardiac amyloidosis
  • Session: Late-Breaking Clinical Science: cardiac amyloidosis
    • August 30, 2026, 1:45 PM CEST to 2:00 PM CEST, Achgabat (Hall A3)

Chronic Kidney Disease

• Effects of finerenone in patients with hypertensive nephropathy
  • Session: Late-Breaking Clinical Science: renin-angiotensin-aldosterone pathway inhibition
    • August 30, 2026, 1:45 PM CEST to 2:00 PM CEST, Rome (ICM)
• Efficacy and safety of finerenone in patients with chronic kidney disease and cardiovascular diseases: An individual participant data pooled analysis (INFINITY)
  • Session: Late-Breaking Clinical Science: renin-angiotensin-aldosterone pathway inhibition
    • August 30, 2026, 2:45 PM CEST to 3:00 PM CEST, Rome (ICM)
• Systolic blood pressure variability and effect of finerenone treatment in patients with chronic kidney disease and type 2 diabetes: a FIDELITY analysis
  • Session: Secondary prevention after myocardial infarction
    • August 29, 2026, 08:35–08:45 CEST, Science Box 2 - Research Gateway - Hall A1
• Simultaneous versus sequential initiation of CKM therapies: an indirect comparison of CONFIDENCE and FIDELITY
  • Session: Optimising pharmacotherapy in heart failure
    • August 30, 2026, 12:24–12:36 CEST, Science Box 5 - Research Gateway - Hall A1
• Finerenone with empagliflozin according to body mass index in chronic kidney disease and type 2 diabetes
  • Session: Unexpected consequences of cardiometabolic disease
    • August 30, 2026, 15:10–15:30 CEST, Science Box 3 - Research Gateway - Hall A1
• Real-world effectiveness and safety of finerenone in patients with chronic kidney disease and type 2 diabetes in the United States: A FOUNTAIN platform analysis
  • Session: Cardiovascular pharmacotherapy in advanced kidney disease: efficacy, safety, and outcomes
    • August 29, 2026, 16:35–16:45 CEST, Science Box 1 - Research Gateway - Hall A1

Heart Failure

• Finerenone and serum sodium in patients with heart failure and mildly reduced or preserved ejection fraction: an analysis of FINEARTS-HF
  • Session: Optimising pharmacotherapy in heart failure
    • August 30, 2026, 12:48–13:00 CEST, Science Box 5 - Research Gateway - Hall A1
• Time in blood pressure range and cardiovascular outcomes in HFmrEF/HFpEF: a pooled participant-level analysis of four large-scale trials
  • Session: Drivers of heart failure with preserved ejection fraction
    • August 30, 2026, 17:30–17:40 CEST, Science Box 3 - Research Gateway - Hall A1
• Cardiovascular-kidney-metabolic overlap and finerenone in heart failure: insights from the FINEARTS-HF Trial
  • Session: HFpEF: targeting the underlying pathophysiology
    • August 31, 2026, 14:40–14:50 CEST, Science Box 3 - Research Gateway - Hall A1
• GenePHIT Phase 2 baseline characteristics: a double blind, placebo-controlled trial to assess safety and efficacy of AB-1002 gene therapy in heart failure with reduced ejection fraction
  • Session: Targeting the pathophysiology of HFrEF
    • August 29, 2026, 17:10-17:20 CEST, Science Box 3 – Research Gateway – Hall A1

Secondary Stroke Prevention

• Dual antiplatelet therapy (DAPT) during the first 90 days post-randomisation in OCEANIC-STROKE: participant characteristics and interaction with asundexian
  • Session: Advances in stroke prevention: anticoagulation, antiplatelet therapy and left atrial appendage closure
    • August 31, 2026, 1:15 PM CEST to 1:30 PM CEST, Bratislava (ICM)

ABOUT KERENDIA

INDICATIONS:

KERENDIA (finerenone) is indicated to reduce the risk of:

• sustained estimated glomerular filtration rate (eGFR) decline, end-stage kidney disease, cardiovascular death, non-fatal myocardial infarction, and hospitalization for heart failure in adult patients with chronic kidney disease (CKD) associated with type 2 diabetes (T2D) (10mg, 20mg tablets)
• cardiovascular death, hospitalization for heart failure, and urgent heart failure visits in adult patients with heart failure with left ventricular ejection fraction (HF LVEF) ≥40% (10mg, 20mg, 40mg tablets)

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS:

• Hypersensitivity to any component of this product
• Concomitant use with strong CYP3A4 inhibitors
• Patients with adrenal insufficiency

WARNINGS AND PRECAUTIONS:

• Hyperkalemia: KERENDIA can cause hyperkalemia. The risk for developing hyperkalemia increases with decreasing kidney function and is greater in patients with higher baseline potassium levels or other risk factors for hyperkalemia.
  
  Measure serum potassium and eGFR in all patients before initiation of treatment with KERENDIA and dose accordingly. Do not initiate KERENDIA if serum potassium is >5 mEq/L. Measure serum potassium periodically during treatment with KERENDIA and adjust dose accordingly. More frequent monitoring may be necessary for patients at risk for hyperkalemia, including those on concomitant medications that impair potassium excretion or increase serum potassium.

• Worsening of Renal Function in Patients with Heart Failure: KERENDIA can cause worsening of renal function in patients with heart failure. Rarely, severe events associated with worsening renal function, including events requiring hospitalization, have been observed.
  
  Measure eGFR in all patients before initiation of treatment or with dose titration of KERENDIA and dose accordingly. Initiation of KERENDIA in patients with heart failure and an eGFR <25 mL/min/1.73 m2 is not recommended. Measure eGFR periodically during maintenance treatment with KERENDIA in patients with heart failure. Consider delaying up-titration or interrupting treatment with KERENDIA in patients who develop clinically significant worsening of renal function.

MOST COMMON ADVERSE REACTIONS:

• CKD associated with T2D: From the pooled data of FIDELIO-DKD and FIGARO-DKD, the adverse reactions reported in ≥1% of patients on KERENDIA and more frequently than placebo were hyperkalemia (14% vs 6.9%), hypotension (4.6% vs 3%), and hyponatremia (1.3% vs 0.7%).
• HF LVEF ≥40%: From FINEARTS-HF, the adverse reactions reported in ≥1% of patients on KERENDIA and more frequently than placebo were hyperkalemia (9.7% vs 4.2%), hypotension (7.6% vs 4.7%), and hyponatremia (1.9% vs 0.9%).1 Events related to worsening renal function were reported more frequently in the KERENDIA group (18%) compared with placebo (12%).

DRUG INTERACTIONS:

• Strong CYP3A4 Inhibitors: Concomitant use of KERENDIA with strong CYP3A4 inhibitors is contraindicated. Avoid concomitant intake of grapefruit or grapefruit juice.
• Moderate and Weak CYP3A4 Inhibitors: Monitor serum potassium during drug initiation or dosage adjustment of either KERENDIA or the moderate or weak CYP3A4 inhibitor, and adjust KERENDIA dosage as appropriate.
• Strong and Moderate CYP3A4 Inducers: Avoid concomitant use of KERENDIA with strong or moderate CYP3A4 inducers.
• Sensitive CYP2C8 Substrates at KERENDIA 40mg: Monitor patients more frequently for adverse reactions caused by sensitive CYP2C8 substrates if KERENDIA 40mg is co-administered with such substrates, since minimal concentration changes may lead to serious adverse reactions.

USE IN SPECIFIC POPULATIONS:

• Lactation: Avoid breastfeeding during treatment with KERENDIA and for 1 day after treatment.
• Hepatic Impairment: Avoid use of KERENDIA in patients with severe hepatic impairment (Child Pugh C) and consider additional serum potassium monitoring with moderate hepatic impairment (Child Pugh B).

Please see the Prescribing Information for KERENDIA.

ABOUT I 124 EVUZAMITIDE

Iodine 124 evuzamitide (I 124 evuzamitide) is an investigational radioactive diagnostic imaging agent being studied in patients with suspected cardiac amyloidosis. I 124 evuzamitide has received FDA Breakthrough Therapy Designation for PET imaging in patients with suspected or known cardiac amyloidosis as well as Orphan Drug designation for both light-chain amyloidosis (AL) and transthyretin amyloidosis (ATTR) in the U.S. and EU. I 124 evuzamitide is an investigational compound and has not been approved by any health authority for use in any country for any indication.

ABOUT ASUNDEXIAN

Asundexian, a direct inhibitor of Factor XIa (FXIa), is theorized to reduce thrombus formation, without an increase in major bleeding. Asundexian is currently being evaluated as a potential treatment option to reduce the risk of stroke in adults after a non cardioembolic ischemic stroke or high-risk transient ischemic attack (TIA). Asundexian is a once-daily, oral investigational agent and has not been approved by any health authority for use in any country, for any indication.

ABOUT BAYER’S COMMITMENT IN CARDIOVASCULAR, KIDNEY AND CEREBROVASCULAR MEDICINE

Bayer is a leader in the area of cardiology and is advancing a portfolio of innovative treatments for cardiovascular, kidney and cerebrovascular diseases with high unmet medical needs. The company has set a clear focus on developing therapies to treat such diseases (e.g., heart failure, cardiomyopathies, chronic kidney disease and secondary stroke prevention), and it is our ambition to take a leading role in the care of patients with these diseases. Bayer’s portfolio already includes several innovative products and compounds in various stages of preclinical and clinical development. Together, these products reflect the company’s approach to research, which prioritizes targets and pathways with the potential to impact the way that cardiovascular, kidney and cerebrovascular diseases are treated.

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.

PP-EVU-US-0009-1 8/26

View source version on businesswire.com: https://www.businesswire.com/news/home/20260820727981/en/

U.S. contacts for media inquiries:

Elaine Colón (evuzamitide)

Phone: +1-732-236-1587

Email: [email protected]

Joshua Mansbach (KERENDIA)

Phone: +1-201-626-8929

Email: [email protected]

Sarra Herzog (asundexian)

Phone: +1-862-460-8764

Email: [email protected]

Source: Bayer