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Bayer (BAYRY) Starts Mid-Stage Study on Chronic Kidney Disease Drug
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Bayer (BAYRY - Free Report) announces the initiation of the phase II, ALPINE-1 study, on pipeline candidate BAY3283142 following the successful first-in-human trials.
BAY3283142, an investigational soluble guanylate cyclase (sGC) activator, is being evaluated for patients with chronic kidney disease (CKD).
APLINE-1 is a randomized, double-blind, placebo-controlled, multicenter study that will assess the efficacy and safety of BAY3283142 in CKD patients.
CKD is a progressive condition affecting more than 10% of the global population or 850 million people roughly. CKD is one of the most frequent complications arising from diabetes. It is also an independent risk factor for cardiovascular disease.
Bayer is looking to revive its pharmaceutical portfolio amid generic competition for Xarelto and challenges for its Crop Science Division.
Sales in the Pharmaceuticals Division increased 4.5% to €4.6 billion in the second quarter of 2024, driven by strong performance of new drugs like Nubeqa and Kerendia. Eylea also continues to perform well.
Kerendia is approved for the treatment of patients with CKD associated with type 2 diabetes. A substantial rise in the sales volume of the drug in the United States drove its performance in the second quarter.
Bayer currently has quite a few phase III studies ongoing on new candidates as well as label expansion of the existing drugs.
The company is working to get a higher dose of Eylea approved. Bayer is also working on label expansion of Nubeqa and Kerendia in various indications.
Elinzanetant, a dual neurokinin-1,3 (NK-1,3) receptor antagonist, is in late-stage clinical development for the non-hormonal treatment of moderate to severe vasomotor symptoms (VMS) associated with menopause, administered orally once daily.
However, the late-stage study, OCEANIC-AF, investigating asundexian compared with direct oral anticoagulant Eliquis (apixaban) in patients with atrial fibrillation and at risk for stroke, was stopped early due to the lack of efficacy. This was a major setback, given the candidate’s potential.
Pipeline setbacks and regulatory setbacks have weighed on the stock in recent times. Bayer’s pipeline needs to deliver amid current circumstances.
Year to date, shares of Bayer have lost 16.8% against the industry’s growth of 26.4%.
Image Source: Zacks Investment Research
BAYRY’s shares rose last week after the company achieved a legal victory in the ongoing lawsuit over claims that its Roundup weed killer causes cancer.
Per Reuters, The 3rd U.S. Circuit Court of Appeals in Philadelphia ruled in favor of Bayer, stating that federal law shields the company from liability in a lawsuit brought by a Pennsylvania landscaper, David Schaffner, who alleged that the product caused his non-Hodgkin's lymphoma.
The verdict gave investors a reason to cheer as the ongoing Roundup litigation in the United States has adversely impacted Bayer’s cash position due to high legal costs. Bayer, however, has consistently maintained that Roundup and its active ingredient, glyphosate, are safe for use.
Earnings estimates for 2024 have risen from $13.71 to $15.77 per share over the past 30 days. For 2025, the bottom-line estimate has risen from $19.42 to $22.79 over the same timeframe. Year to date, Lilly’s shares have risen 63.7%.
In the past 60 days, estimates for EXEL’s 2024 earnings per share have moved north to $1.79 from $1.39. Year to date, shares of EXEL have risen 7.5%.
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Bayer (BAYRY) Starts Mid-Stage Study on Chronic Kidney Disease Drug
Bayer (BAYRY - Free Report) announces the initiation of the phase II, ALPINE-1 study, on pipeline candidate BAY3283142 following the successful first-in-human trials.
BAY3283142, an investigational soluble guanylate cyclase (sGC) activator, is being evaluated for patients with chronic kidney disease (CKD).
APLINE-1 is a randomized, double-blind, placebo-controlled, multicenter study that will assess the efficacy and safety of BAY3283142 in CKD patients.
CKD is a progressive condition affecting more than 10% of the global population or 850 million people roughly. CKD is one of the most frequent complications arising from diabetes. It is also an independent risk factor for cardiovascular disease.
Bayer is looking to revive its pharmaceutical portfolio amid generic competition for Xarelto and challenges for its Crop Science Division.
Sales in the Pharmaceuticals Division increased 4.5% to €4.6 billion in the second quarter of 2024, driven by strong performance of new drugs like Nubeqa and Kerendia. Eylea also continues to perform well.
Kerendia is approved for the treatment of patients with CKD associated with type 2 diabetes. A substantial rise in the sales volume of the drug in the United States drove its performance in the second quarter.
Bayer currently has quite a few phase III studies ongoing on new candidates as well as label expansion of the existing drugs.
The company is working to get a higher dose of Eylea approved. Bayer is also working on label expansion of Nubeqa and Kerendia in various indications.
Elinzanetant, a dual neurokinin-1,3 (NK-1,3) receptor antagonist, is in late-stage clinical development for the non-hormonal treatment of moderate to severe vasomotor symptoms (VMS) associated with menopause, administered orally once daily.
However, the late-stage study, OCEANIC-AF, investigating asundexian compared with direct oral anticoagulant Eliquis (apixaban) in patients with atrial fibrillation and at risk for stroke, was stopped early due to the lack of efficacy. This was a major setback, given the candidate’s potential.
Pipeline setbacks and regulatory setbacks have weighed on the stock in recent times. Bayer’s pipeline needs to deliver amid current circumstances.
Year to date, shares of Bayer have lost 16.8% against the industry’s growth of 26.4%.
Image Source: Zacks Investment Research
BAYRY’s shares rose last week after the company achieved a legal victory in the ongoing lawsuit over claims that its Roundup weed killer causes cancer.
Per Reuters, The 3rd U.S. Circuit Court of Appeals in Philadelphia ruled in favor of Bayer, stating that federal law shields the company from liability in a lawsuit brought by a Pennsylvania landscaper, David Schaffner, who alleged that the product caused his non-Hodgkin's lymphoma.
The verdict gave investors a reason to cheer as the ongoing Roundup litigation in the United States has adversely impacted Bayer’s cash position due to high legal costs. Bayer, however, has consistently maintained that Roundup and its active ingredient, glyphosate, are safe for use.
Zacks Rank & Stocks to Consider
BAYRY currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks from the healthcare industry are Eli Lilly (LLY - Free Report) and Exelixis (EXEL - Free Report) , both carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Earnings estimates for 2024 have risen from $13.71 to $15.77 per share over the past 30 days. For 2025, the bottom-line estimate has risen from $19.42 to $22.79 over the same timeframe. Year to date, Lilly’s shares have risen 63.7%.
In the past 60 days, estimates for EXEL’s 2024 earnings per share have moved north to $1.79 from $1.39. Year to date, shares of EXEL have risen 7.5%.