Bayer Gets FDA Nod for Label Expansion of Kerendia in Heart Failure

Globe and Mail

19 hours ago

Bayer AG BAYRY announced that the FDA has approved a label expansion of kidney disease drug Kerendia (finerenone).
The regulatory body approved finerenone for the treatment of adult patients with heart failure (HF) and a left ventricular ejection fraction (LVEF) of ≥40%.
The approval of finerenone by the FDA for this new indication is based on the positive results of the late-stage FINEARTS-HF study, which is part of the ongoing MOONRAKER program — one of the largest phase III clinical trial programs to date in heart failure.
Year to date, shares of Bayer have rallied 64.1% compared with the industry 's growth of 1.8%.
More on Bayer's Kerendia
Finerenone is a non-steroidal, selective mineralocorticoid receptor (MR) antagonist that has been shown to block harmful effects of MR overactivation. MR overactivation contributes to chronic kidney disease (CKD) progression and cardiovascular damage caused by metabolic, hemodynamic, or inflammatory and fibrotic factors.
Finerenone is marketed as Kerendia (Firialta in some countries) and is already approved for the treatment of adult patients with CKD associated with type 2 diabetes (T2D) in more than 95 countries worldwide, including China, Europe, Japan and the United States.
With the latest FDA approval, Kerendia is the only non-steroidal MR antagonist approved in the United States for CKD associated with T2D and for HF with LVEF of ≥40%.
Please note the FDA granted Priority Review designation to the supplemental new drug application seeking approval for finerenone for the treatment of adult patients with HF with an LVEF of ≥40%.
Per estimates, approximately 3.7 million people in the United States live with HF with an LVEF of ≥40%, which accounts for more than 500,000 hospitalizations per year.
Data from the FINEARTS-HF study showed that finerenone achieved a statistically significant and clinically meaningful reduction of the composite of cardiovascular death and total (first and recurrent) HF events, defined as hospitalizations for HF or urgent HF visits. These benefits were demonstrated regardless of background therapy, comorbidities, or hospitalization status.
Finerenone has also been submitted for marketing authorization in HF with an LVEF of ≥40% in China, the EU and Japan.
BAYRY's Efforts to Strengthen Pharma Business
Bayer's new products, such as Nubeqa and Kerendia, continue to maintain their impressive momentum in the Pharmaceutical division and offset the negative impact of a decline in Xarelto sales.
Labels of these key drugs should boost its top-line growth. Last month, the FDA also expanded Nubeqa's label for a third indication for patients with advanced prostate cancer.
The successful development of additional drugs is imperative for Bayer amid multiple challenges. BAYRY expects to launch two new drugs — elinzanetant, a hormone-free treatment for menopause symptoms, and acoramidis, a drug for the treatment of a certain type of heart disease.
Elinzanetant was recently approved in the UK for the treatment of moderate to severe vasomotor symptoms (VMS or hot flashes) associated with menopause under the brand name Lynkuet.
The company also aims to strengthen its pharmaceutical pipeline. In 2021, Bayer acquired clinical-stage biopharmaceutical company Vividion Therapeutics to expand its presence in precision small-molecule therapeutics, primarily in oncology and immunology.
BAYRY has expanded its pipeline in new modalities of cell therapy through the acquisition of BlueRock, and in gene therapy, through the AskBio buyout.
Bayer's Zacks Rank & Other Key Picks
BAYRY currently carries a Zacks Rank #1 (Strong). A couple of other top-ranked stocks in the large-cap pharma sector are Novartis NVS and Johnson & Johnson JNJ, both carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today's Zacks #1 Rank stocks here.
The Zacks Consensus Estimate for Novartis' 2025 earnings per share (EPS) has risen from $8.78 to $8.92 over the past 60 days. EPS estimates for 2026 have jumped 20 cents to $9.27 during the said timeframe. The stock has risen 27.3% so far this year.
J&J's EPS estimate for 2025 has risen from $10.60 to $10.64 over the past 60 days, while that for 2026 has increased from $10.98 to $11.07 over the same timeframe.
5 Stocks Set to Double
Each was handpicked by a Zacks expert as the favorite stock to gain +100% or more in the months ahead. They include
Stock #1: A Disruptive Force with Notable Growth and Resilience
Stock #2: Bullish Signs Signaling to Buy the Dip
Stock #3: One of the Most Compelling Investments in the Market
Stock #4: Leader In a Red-Hot Industry Poised for Growth
Stock #5: Modern Omni-Channel Platform Coiled to Spring
Most of the stocks in this report are flying under Wall Street radar, which provides a great opportunity to get in on the ground floor. While not all picks can be winners, previous recommendations have soared +171%, +209% and +232%.
Download Atomic Opportunity: Nuclear Energy's Comeback free today.
Novartis AG (NVS): Free Stock Analysis Report
Johnson & Johnson (JNJ): Free Stock Analysis Report
Bayer Aktiengesellschaft (BAYRY): Free Stock Analysis Report