Bayer's sNDA for Kerendia Label Expansion Gets FDA's Priority Review

Bayer AG BAYRY recently announced that the FDA had accepted its supplemental new drug application (sNDA) seeking approval for Kerendia (finerenone) to treat a new indication. The sNDA seeks approval for Kerendia for the treatment of adult patients with heart failure (HF) with a left ventricular ejection fraction (LVEF) of ≥40%, i.e., mildly reduced LVEF (HFmrEF) or preserved LVEF (HFpEF).With the FDA granting a priority review to the sNDA, a decision from the regulatory body is expected in the third quarter of 2025. The priority review from the FDA usually brings down the review period to six months, compared to the standard review time of 10 months.We note that finerenone is already marketed as Kerendia or, in some countries, as Firialta, and approved for the treatment of adult patients with chronic kidney disease associated with type 2 diabetes in more than 90 countries across the world, including China, Europe, Japan and the United States.In the past year, shares of Bayer have lost 6.4% compared with the industry’s decline of 5.9%.Image Source: Zacks Investment ResearchBAYRY's sNDA for Kerendia Based on FINEARTS-HF StudyThe latest sNDA for Kerendia was based on positive data from the phase III FINEARTS-HF study, which is part of the ongoing MOONRAKER study program.The double-blind, placebo-controlled FINEARTS-HF study evaluated the safety and efficacy of Kerendia for the prevention of cardiovascular death and HF events in patients with a diagnosis of symptomatic HF with an LVEF of ≥40%.Data from the FINEARTS-HF study showed that treatment with Kerendia led to a statistically significant improvement in cardiovascular outcomes in patients with HF and an LVEF of greater than or equal to 40% versus placebo.Regulatory applications seeking approval for finerenone in HF with an LVEF of ≥40% are currently under review in the European Union, China and Japan.Per management, finerenone is the first drug targeting the mineralocorticoid receptor pathway which has shown cardiovascular benefits in a phase III study for treating HF with an LVEF of ≥40%.Currently, finerenone is not approved for the treatment of HF. A potential approval for HF indication should help Bayer address a broader patient population and drive long-term growth, as there are limited treatment options with proven efficacy available currently.BAYRY's Zacks Rank & Other Stocks to ConsiderBayer currently carries a Zacks Rank #2 (Buy).Some better-ranked stocks in the biotech sector are ANI Pharmaceuticals, Inc. ANIP and CytomX Therapeutics, Inc. CTMX, each sporting a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.In the past 60 days, estimates for ANI Pharmaceuticals’ earnings per share have increased from $5.54 to $6.35 for 2025. During the same time, earnings per share have increased from $6.75 to $7.21 for 2026. In the past year, shares of ANIP have lost 5.2%.ANIP’s earnings beat estimates in each of the trailing four quarters, the average surprise being 17.32%.In the past 60 days, estimates for CytomX Therapeutics’ have moved from a loss of 31 cents per share to earnings of 25 cents for 2025. During the same time, loss per share has narrowed from 65 cents to 31 cents for 2026. In the past year, shares of CTMX have plunged 71%.CTMX’s earnings beat estimates in three of the trailing four quarters while missing the same on the remaining occasion, the average surprise being 180.70%.5 Stocks Set to DoubleEach was handpicked by a Zacks expert as the #1 favorite stock to gain +100% or more in 2024. While not all picks can be winners, previous recommendations have soared +143.0%, +175.9%, +498.3% and +673.0%.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.Today, See These 5 Potential Home Runs >>Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Bayer Aktiengesellschaft (BAYRY): Free Stock Analysis Report ANI Pharmaceuticals, Inc. (ANIP): Free Stock Analysis Report CytomX Therapeutics, Inc. (CTMX): Free Stock Analysis ReportThis article originally published on Zacks Investment Research (zacks.com).Zacks Investment ResearchWeiter zum vollständigen Artikel bei Zacks Weiter zum vollständigen Artikel bei Zacks