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BAYRYs sNDA for Kerendia in CKD tied to type I diabetes received FDA Priority Review.
Finerenone cut UACR by 25% over six months in the phase III FINE-ONE study in adults.
Kerendia Q1 sales rose 70% year over year, driven by higher U.S. and China volumes.
Bayer AG (BAYRY - Free Report) announced that the FDA has accepted the company’s supplemental new drug application (sNDA) seeking label expansion of Kerendia (finerenone) for the treatment of chronic kidney disease (CKD) associated with type I diabetes (T1D).
The regulatory body granted Priority Review designation to the sNDA.
The FDA grants Priority Review to drugs that could significantly improve the treatment, diagnosis, or prevention of serious conditions versus existing therapies. The designation shortens the FDA review timeline for a new drug application to about six months, compared with the standard 10-month review period.
More on BAYRY’s Kerendia
Finerenone is a selective, non-steroidal mineralocorticoid receptor antagonist designed to block the harmful effects of MR overactivation.
The latest filing is backed by positive phase III FINE-ONE study results, which were published in the New England Journal of Medicine in March 2026.
Study results showed that finerenone, added to standard of care, significantly reduced urine albumin-to-creatinine ratio (UACR) by 25% from baseline over six months compared with placebo in adults with CKD associated with type I diabetes.
UACR is a key marker of kidney damage and cardiovascular risk in diabetes-related CKD, with lower levels linked to improved kidney and heart outcomes. Earlier phase III studies in CKD associated with type II diabetes — FIDELIO-DKD and FIGARO-DKD — showed that finerenone-driven UACR reductions were strongly associated with delayed kidney disease progression, lower risk of kidney failure and fewer cardiovascular events.
We remind investors that finerenone is marketed as Kerendia, or Firialta in select countries, for adults with CKD linked to type II diabetes, with approvals in more than 100 countries, including the United States, Europe, China and Japan.
The drug has been approved in the United States since July 2025 for heart failure with LVEF ≥40% following Priority Review designation. The drug has also secured approvals in the EU, Japan, and other markets, while additional applications, including in China, remain under review.
Kerendia generated sales of €274 million in the first quarter, up 70% year over year fueled by a substantial rise in volumes in the United States and China. Additional label expansions of the drug will further boost sales.
BAYRY Looks to Strengthen Pharma Business
Bayer’s recent turnaround has been phenomenal and it is now looking to expand its diverse portfolio.
Shares of Bayer have surged 63.9% over the past year compared with the industry’s gain of 24.5%.
Image Source: Zacks Investment Research
The strong performance of Nubeqa and Kerendia has enabled the company to combat the decline in sales of oral anticoagulant Xarelto, which is co-developed with Johnson & Johnson (JNJ - Free Report) .
Xarelto is marketed by Johnson & Johnson in the United States. Bayer earns license revenues from JNJ for Xarelto sales in the United States.
Another key drug, Eylea, continues to face pressure from generics. The introduction of Eylea 8 mg, with its extended dosing intervals, has partially offset the decline and supported overall performance.
Please note that Bayer’s HealthCare unit co-develops Eylea with Regeneron (REGN - Free Report) , which records net product sales of Eylea in the United States. BAYRY records net product sales of Eylea outside the country. REGN records its share of profits and losses from Eylea sales outside the United States.
Bayer’s portfolio is anchored by five major assets: asundexian, Nubeqa (prostate cancer), Kerendia, Beyonttra and Lynkuet (a dual NK1/NK3 antagonist approved for menopause-related vasomotor symptoms).
Asundexian, an investigational, once daily, oral Factor XIa inhibitor, is being evaluated as a potential treatment for secondary stroke prevention.
Bayer recently announced that the FDA and Japan’s Ministry of Health, Labour and Welfare have accepted new drug applications for its investigational Factor XIa inhibitor, asundexian, to prevent ischemic stroke following non-cardioembolic ischemic stroke or transient ischemic attack.
The FDA has granted Priority Review to sevabertinib for the first-line treatment of adults with locally advanced or metastatic non-small cell lung cancer harboring HER2 (ERBB2) tyrosine kinase domain activating mutations.
View the Zacks #1 Rank List
Image: Bigstock
BAYRY's Kerendia Label Expansion Application Gets Priority Review
Key Takeaways
Bayer AG (BAYRY - Free Report) announced that the FDA has accepted the company’s supplemental new drug application (sNDA) seeking label expansion of Kerendia (finerenone) for the treatment of chronic kidney disease (CKD) associated with type I diabetes (T1D).
The regulatory body granted Priority Review designation to the sNDA.
The FDA grants Priority Review to drugs that could significantly improve the treatment, diagnosis, or prevention of serious conditions versus existing therapies. The designation shortens the FDA review timeline for a new drug application to about six months, compared with the standard 10-month review period.
More on BAYRY’s Kerendia
Finerenone is a selective, non-steroidal mineralocorticoid receptor antagonist designed to block the harmful effects of MR overactivation.
The latest filing is backed by positive phase III FINE-ONE study results, which were published in the New England Journal of Medicine in March 2026.
Study results showed that finerenone, added to standard of care, significantly reduced urine albumin-to-creatinine ratio (UACR) by 25% from baseline over six months compared with placebo in adults with CKD associated with type I diabetes.
UACR is a key marker of kidney damage and cardiovascular risk in diabetes-related CKD, with lower levels linked to improved kidney and heart outcomes. Earlier phase III studies in CKD associated with type II diabetes — FIDELIO-DKD and FIGARO-DKD — showed that finerenone-driven UACR reductions were strongly associated with delayed kidney disease progression, lower risk of kidney failure and fewer cardiovascular events.
We remind investors that finerenone is marketed as Kerendia, or Firialta in select countries, for adults with CKD linked to type II diabetes, with approvals in more than 100 countries, including the United States, Europe, China and Japan.
The drug has been approved in the United States since July 2025 for heart failure with LVEF ≥40% following Priority Review designation. The drug has also secured approvals in the EU, Japan, and other markets, while additional applications, including in China, remain under review.
Kerendia generated sales of €274 million in the first quarter, up 70% year over year fueled by a substantial rise in volumes in the United States and China. Additional label expansions of the drug will further boost sales.
BAYRY Looks to Strengthen Pharma Business
Bayer’s recent turnaround has been phenomenal and it is now looking to expand its diverse portfolio.
Shares of Bayer have surged 63.9% over the past year compared with the industry’s gain of 24.5%.
Image Source: Zacks Investment Research
The strong performance of Nubeqa and Kerendia has enabled the company to combat the decline in sales of oral anticoagulant Xarelto, which is co-developed with Johnson & Johnson (JNJ - Free Report) .
Xarelto is marketed by Johnson & Johnson in the United States. Bayer earns license revenues from JNJ for Xarelto sales in the United States.
Another key drug, Eylea, continues to face pressure from generics. The introduction of Eylea 8 mg, with its extended dosing intervals, has partially offset the decline and supported overall performance.
Please note that Bayer’s HealthCare unit co-develops Eylea with Regeneron (REGN - Free Report) , which records net product sales of Eylea in the United States. BAYRY records net product sales of Eylea outside the country. REGN records its share of profits and losses from Eylea sales outside the United States.
Bayer’s portfolio is anchored by five major assets: asundexian, Nubeqa (prostate cancer), Kerendia, Beyonttra and Lynkuet (a dual NK1/NK3 antagonist approved for menopause-related vasomotor symptoms).
Asundexian, an investigational, once daily, oral Factor XIa inhibitor, is being evaluated as a potential treatment for secondary stroke prevention.
Bayer recently announced that the FDA and Japan’s Ministry of Health, Labour and Welfare have accepted new drug applications for its investigational Factor XIa inhibitor, asundexian, to prevent ischemic stroke following non-cardioembolic ischemic stroke or transient ischemic attack.
The FDA has granted Priority Review to sevabertinib for the first-line treatment of adults with locally advanced or metastatic non-small cell lung cancer harboring HER2 (ERBB2) tyrosine kinase domain activating mutations.
BAYRY’s Zacks Rank & Other Stocks to Consider
Bayer currently carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.