Bayer Aktiengesellschaft BAYRY announced that its investigational candidate, finerenone, met the primary endpoint in a phase III study, FIDELIO-DKD. The study evaluated the efficacy and safety of finerenone versus placebo when added to standard of care in patients with chronic kidney disease (CKD) and Type II diabetes (T2D).
The FIDELIO-DKD study is part of the largest phase III studyto date in CKD and T2D. The study enrolled 13,000 patients across a broad range of disease severity, including those with early kidney damage and more advanced stages of kidney disease. The results showed that finerenone delayed the progression of CKD by significantly reducing the combined risk of time to first occurrence of kidney failure, a sustained decrease of estimated glomerular filtration rate (eGFR) greater than or equal to 40% from baseline over a period of at least four weeks, or renal death. Finerenone also reduced the risk of the key secondary endpoints — a composite of time to first occurrence of cardiovascular (CV) death, non-fatal myocardial infarction, non-fatal stroke, or heart failure hospitalization. The clinical data from FIDELIO-DKD will be presented at an upcoming scientific meeting.
Shares of the company have lost 8.9% year to date while the industry did not show any movement.
Finerenone (BAY 94-8862) is an investigational, non-steroidal, selective mineralocorticoid receptor antagonist that has been shown to block the harmful effects of the over-activated mineralocorticoid receptor (MR) system. MR overactivation is a major driver of heart and kidney damage. It is the first non-steroidal MR antagonist being developed in heart failure with preserved ejection fraction.
Last month, the company also initiated a placebo-controlled phase III study, FINEARTS-HF, on finerenone. The study will investigate finerenone compared to placebo in more than 5,500 symptomatic heart failure patients with a left ventricular ejection fraction of ≥40%.
.The primary objective of the study is to demonstrate the superiority of finerenone over placebo in reducing the rate of the composite endpoint of cardiovascular death and total (first and recurrent) heart failure (HF) events.
Bayer Aktiengesellschaft Price
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Zacks Rank and Stocks to Consider
Bayer currently carries a Zacks Rank #2 (Buy).
A few top-ranked stocks worth considering in the large-cap pharma sector include AbbVie Plc ABBV, Eli Lilly and Company LLY, and H. Lundbeck A/S HLUYY. While AbbVie and Lilly carry a Zacks Rank #1 (Strong Buy), H. Lundbeck carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
AbbVie’s earnings estimates have increased from $9.81 to $10.42 for 2020 and from $11.28 to $12.03 for 2021 over the past 90 days.
Eli Lilly’s earnings estimates have increased from $6.81 to $6.82 for 2020 over the past 60 days.
H. Lundbeck’s earnings estimates have increased from $2.16 to $2.20 for 2020 and from $2.18 to $2.19 for 2021 over the past 60 days.
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