Bayer to Present First Full FIND-CKD Results Investigating KERENDIA® (finerenone) in Non-Diabetic Chronic Kidney Disease at ERA 2026

Presentations also include the INFINITY pooled analysis of KERENDIA® (finerenone) across diabetic and non-diabetic chronic kidney disease.

Whippany, N.J., June 2, 2026 - FOR IMMEDIATE RELEASE

Summary
Bayer today announced that new investigational data from KERENDIA's Phase III clinical trial program will be presented in scientific sessions at the 63rd European Renal Association (ERA) Congress taking place June 3-6, 2026, in Glasgow, Scotland. Presentations include:

• The first full data results from the global FIND-CKD (NCT05047263) study evaluating the addition of KERENDIA to standard of care in adults with non-diabetic chronic kidney disease (nd-CKD).
  o A prespecified subgroup analysis of FIND-CKD that evaluated KERENDIA in people living with glomerulonephritis.
• Initial results from the INFINITY pooled analysis which includes data from clinical studies of KERENDIA across adults with either type 2 diabetes (T2D) and chronic kidney disease (CKD) or nd-CKD.
• KERENDIA is currently approved by the FDA for use in adults with CKD associated with T2D, as well as adults with heart failure (HF) with left ventricular ejection fraction (LVEF) ≥40%.¹
  

Key Facts

• Data from the Phase III FIND-CKD study represent the first full presentation of results evaluating KERENDIA in adults with nd-CKD.
• INFINITY is a pooled analysis including data from three Phase III trials-FIDELIO-DKD, FIGARO-DKD, and FIND-CKD-designed to evaluate KERENDIA across CKD populations, including adults with CKD associated with T2D and those with nd-CKD.

Why This Matters
CKD is a progressive disease that can lead to cardiovascular complications and kidney failure.² Treatment approaches vary depending on the underlying cause of CKD and patient characteristics, and unmet medical need remains in certain populations, including those without diabetes and individuals with inflammatory kidney diseases such as glomerulonephritis.³

Bayer Late-Breaking Presentations at ERA 2026 include:

• Finerenone in patients with chronic kidney disease
  o Presenter: Hiddo J. L. Heerspink
  o Location: Clyde Plenary Room
  o Date/Time: June 5th, 11:15 - 11:35 BST
• Finerenone in patients with glomerulonephritis
  o Presenter: Vlado Perkovic
  o Location: Clyde Plenary Room
  o Date/Time: June 5th, 11:35 - 11:45 BST
• Efficacy and safety of finerenone in patients with chronic kidney disease: An individual participant data pooled analysis (INFINITY)
  o Presenter: Brendon Neuen
  o Location: Clyde Plenary Room
  o Date/Time: June 5th, 11:45 - 11:55 BST

About KERENDIA's Clinical Trial Program
KERENDIA's clinical trial program-called FINEOVATE-currently comprises 12 Phase III studies with dedicated programs in heart failure (MOONRAKER) and CKD (THUNDERBALL).

• The MOONRAKER program includes FINEARTS-HF⁸ as well as the ongoing, collaborative, investigator-sponsored studies REDEFINE-HF,⁹ CONFIRMATION-HF,¹⁰ FINALITY-HF,¹¹ FIORE¹² and FIORELLO.¹³
• The THUNDERBALL CKD program consists of the completed studies FIDELIO-DKD,¹⁴ FIGARO-DKD,¹⁵ FINE-ONE¹⁶ and FIND-CKD¹⁷ as well as the ongoing investigational studies, FIONA,¹⁸ and FIONA-OLE.¹⁹

About KERENDIA® (finerenone)¹
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%). 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 Bayer's Commitment in Cardiovascular and Kidney Diseases
Bayer's legacy in cardiovascular care spans decades of scientific innovation and patient-focused research. As a long-standing leader in cardiology, Bayer has consistently advanced therapies that address the complex interplay between the heart and kidneys-two organs deeply connected in both health and disease. Today, that heritage continues to guide our commitment to developing innovative treatments for patients facing high unmet medical needs.

With a growing portfolio of approved therapies and promising compounds in development, Bayer is shaping the future of cardiovascular care through precision medicine, scientific rigor, and a deep sense of purpose.

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.

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.

Media Contact
Sarra Herzog
Bayer Media Relations
[email protected]
+1 862.460.8764

References

<sup>1. KERENDIA (finerenone) [prescribing information]. Whippany, NJ: Bayer HealthCare Pharmaceuticals, Inc: August 2025.
2. National Kidney Foundation. Chronic kidney disease (CKD). National Kidney Foundation. Published 2023. https://www.kidney.org/kidney-topics/chronic-kidney-disease-ckd
3. Heerspink HJL, Agarwal R, Bakris GL, et al. Design and baseline characteristics of the Finerenone, in addition to standard of care, on the progression of kidney disease in patients with Non-Diabetic Chronic Kidney Disease (FIND-CKD) randomized trial. Nephrol Dial Transplant. 2025;40(2):308-319. doi:10.1093/ndt/gfae132
4. Jager KJ, et al. Kidney Int. 2019;96(5):1048-1050.
5. GBD 2017 Disease and Injury Incidence and Prevalence Collaborators. The Lancet. 2018;392(10159):1789-1858
6. Wanner C, et al. BMC Nephrol. 2025;26:1-11. / Webster AC, Nagler EV, Morton RL, Masson P. Chronic kidney disease. Lancet. 2017;389:1238-52.
7. NIDDK. Kidney disease statistics for the United States. National Institute of Diabetes and Digestive and Kidney Diseases. Published 2023. Accessed March 4, 2026. https://www.niddk.nih.gov/health-information/health-statistics/kidney-disease
8. Study to Evaluate the Efficacy (Effect on Disease) and Safety of Finerenone in Participants With Heart Failure and Left Ventricular Ejection Fraction (Proportion of Blood Expelled Per Heart Stroke) Greater or Equal to 40% (FINEARTS-HF) Clinical trial registration No. NCT04435626. https://clinicaltrials.gov/study/NCT04435626 Accessed March 4, 2026
9. A Study to Determine the Efficacy and Safety of Finerenone on Morbidity and Mortality Among Hospitalized Heart Failure Patients (REDEFINE-HF). Clinical trial registration No. NCT 06008197. https://www.clinicaltrials.gov/study/NCT06008197. Accessed March 10, 2025.
10. A Study to Determine the Efficacy and Safety of Finerenone and SGLT2i in Combination in Hospitalized Patients with Heart Failure (CONFIRMATION-HF) (CONFIRMATION). Clinical trial registration No. NCT06024746. https://www.clinicaltrials.gov/study/NCT06024746. Accessed March 10, 2025.
11. A Study to Evaluate Finerenone on Clinical Efficacy and Safety in Patients with Heart Failure Who are Intolerant or Not Eligible for Treatment with Steroidal Mineralocorticoid Receptor Antagonists (FINALITY-HF). Clinical trial registration No. NCT06033950. https://www.clinicaltrials.gov/study/NCT06033950. Accessed March 10, 2025.
12. A Study to Learn More About How Well Finerenone Works, How Safe it is, and How it Moves Into, Through, and Out of the Body Compared to Placebo When Taken With Standard Treatment in Children With Heart Failure and Left Ventricular Systolic Dysfunction (FIORE). Clinical trial registration No. NCT07188805. https://clinicaltrials.gov/study/NCT07188805. Accessed May 22, 2026.
13. A Study to Learn More About How Safe Finerenone is, When it is Taken for a Longer Time With Standard Treatment, in Children and Young Adults With Heart Failure and Left Ventricular Systolic Dysfunction (FIORELLO). Clinical trial registration No. NCT07192952. https://clinicaltrials.gov/study/NCT07192952. Accessed May 22, 2026.
14. Efficacy and Safety of Finerenone in Subjects With Type 2 Diabetes Mellitus and Diabetic Kidney Disease (FIDELIO-DKD) Clinical trial registration No. NCT02540993. https://clinicaltrials.gov/study/NCT02540993. Accessed March 4, 2026.
15. Efficacy and Safety of Finerenone in Subjects With Type 2 Diabetes Mellitus and the Clinical Diagnosis of Diabetic Kidney Disease (FIGARO-DKD) Clinical trial registration No. NCT02545049 https://clinicaltrials.gov/study/NCT02545049. Accessed March 4, 2026.
16. A Study to Learn How Well the Study Treatment Finerenone Works and How Safe it is in People With Long-term Decrease in the Kidneys' Ability to Work Properly (Chronic Kidney Disease) Together With Type 1 Diabetes (FINE-ONE). Clinical trial registration No. NCT05901831. https://www.clinicaltrials.gov/study/NCT05901831. Accessed March 4, 2026.
17. A Trial to Learn How Well Finerenone Works and How Safe it is in Adult Participants With Non-diabetic Chronic Kidney Disease (FIND-CKD). Clinical trial registration No. NCT05047263. https://www.clinicaltrials.gov/study/NCT05047263. Accessed March 4, 2026.
18. A Study to Learn More About How Well the Study Treatment Finerenone Works, How Safe it is, How it Moves Into, Through and Out of the Body, and the Effects it Has on the Body When Taken With an ACE Inhibitor or Angiotensin Receptor Blocker in Children with Chronic Kidney Disease and Proteinuria (FIONA). Clinical trial registration No. NCT05196035. https://www.clinicaltrials.gov/study/NCT05196035. Accessed March 4, 2026.
19. A Study to Learn More About How Safe the Study Treatment Finerenone is in Long-term Use When Taken With an ACE Inhibitor or Angiotensin Receptor Blocker Over 18 Months of Use in Children and Young Adults From 1 to 18 Years of Age With Chronic Kidney Disease and Proteinuria (FIONA OLE). Clinical trial registration No. NCT05457283. https://www.clinicaltrials.gov/study/NCT05457283. Accessed March 4, 2026.
20. Data on file.</sup>