We use cookies to understand how you use our site and to improve your experience. This includes personalizing content and advertising. To learn more, click here. By continuing to use our site, you accept our use of cookies, revised Privacy Policy and Terms of Service.
You are being directed to ZacksTrade, a division of LBMZ Securities and licensed broker-dealer. ZacksTrade and Zacks.com are separate companies. The web link between the two companies is not a solicitation or offer to invest in a particular security or type of security. ZacksTrade does not endorse or adopt any particular investment strategy, any analyst opinion/rating/report or any approach to evaluating individual securities.
If you wish to go to ZacksTrade, click OK. If you do not, click Cancel.
Bayer Submits Application for Label Expansion of Prostate Cancer Drug
Read MoreHide Full Article
Bayer (BAYRY - Free Report) announced the submission of a supplemental new drug application (sNDA) to the FDA for darolutamide.
The sNDA is seeking approval of darolutamide, in combination with androgen deprivation therapy (ADT), in patients with metastatic hormone-sensitive prostate cancer (mHSPC).
Darolutamide is an oral androgen receptor inhibitor (ARi) with a distinct chemical structure that binds to the androgen receptor with high affinity and exhibits strong antagonistic activity. It inhibits the receptor function and the growth of prostate cancer cells while minimizing side effects.
Year to date, shares of Bayer have lost 8.8% against the industry’s growth of 21.6%.
Image Source: Zacks Investment Research
BAYRY’s Clinical Program for Darolutamide
The submission is based on positive results from the phase III ARANOTE study, which showed that darolutamide plus ADT significantly reduced the risk of radiological progression or death by 46% compared to placebo plus ADT in patients with mHSPC.
Darolutamide is already approved under the brand name Nubeqa for the treatment of mHSPC in combination with ADT and docetaxel in several countries. The compound is also approved in combination with ADT for the treatment of patients with non-metastatic castration-resistant prostate cancer (nmCRPC) who are at high risk of developing metastatic disease in more than 85 countries around the world.
Darolutamide plus ADT now has positive data both with and without docetaxel based on two pivotal phase III studies in patients with mHSPC.
Bayer stated that sales of Nubeqa exceeded 1 billion euros year to date in September 2024.
Prostate cancer is the second most common cancer in men and the fifth most common cause of cancer-induced death in men worldwide. A potential approval of darolutamide for a third indication should boost its sales.
BAYRY is also evaluating darolutamide across various stages of prostate cancer in a broad development program.
The program includes the phase III ARASTEP trial evaluating darolutamide plus ADT compared to ADT alone in hormone-sensitive high-risk biochemical recurrence (BCR) prostate cancer patients who have a positive PSMA PET/CT at baseline and no evidence of metastatic disease by conventional imaging.
Bayer is also evaluating darolutamide in the collaborative phase III DASL-HiCaP trial led by the Australian and New Zealand Urogenital and Prostate Cancer Trials Group. The study evaluates darolutamide as an adjuvant treatment for localized prostate cancer with a very high risk of recurrence.
Bayer’s Efforts to Strengthen Pharma Business
Bayer is looking to strengthen its pharmaceutical portfolio amid generic competition for Xarelto.
Sales in the Pharmaceuticals Division increased 4.5% to €4.6 billion in the second quarter of 2024, driven by the strong performance of the cancer drug Nubeqa and chronic kidney disease drug Kerendia. Eylea also continues to perform well.
Bayer’s prostate cancer franchise includes two approved products — Nubeqa and Xofigo. It also has several candidates in its pipeline.
Bayer is working on the label expansion of its approved drugs and simultaneously developing new drugs.
Earlier in the month, Bayer announced that The European Medicines Agency has approved the pre-filled syringe for the administration of Eylea 8mg in the European Union. The approved indications are neovascular age-related macular degeneration and diabetic macular edema (DME).
Eylea 8 mg has been developed to reduce the disease burden and extend treatment intervals with comparable efficacy and safety to the standard-of-care drug Eylea 2 mg.
Eylea 8 mg is approved as Eylea HD in the United States. It is being jointly developed by Bayer and Regeneron Pharmaceuticals (REGN - Free Report) .
Regeneron maintains exclusive rights to Eylea 2 mg (aflibercept 2 mg) and Eylea HD in the United States. Bayer has licensed exclusive marketing rights outside the United States, where the companies equally share the profits from the sales of Eylea 2 mg and Eylea 8 mg following any regulatory approval.
BAYRY’s Zacks Rank & Stocks to Consider
BAYRY currently carries a Zacks Rank #3 (Hold). A couple of better-ranked large-cap pharma companies are Eli Lilly (LLY - Free Report) and Pfizer (PFE - Free Report) . While LLY sports a Zacks Rank #1 (Strong Buy), PFE carries a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
Estimates for Eli Lilly’s 2024 earnings have risen from $13.79 to $16.49 per share over the past 60 days. For 2025, the bottom-line estimate has risen from $19.44 to $23.97 over the same timeframe. Year to date, Lilly’s shares have risen 51.8%.
Estimates for PFE’s 2024 earnings have risen from $2.38 to $2.62 per share over the past 60 days. For 2025, the bottom-line estimate has risen from $2.74 to $2.85 over the same time frame.
See More Zacks Research for These Tickers
Normally $25 each - click below to receive one report FREE:
Image: Bigstock
Bayer Submits Application for Label Expansion of Prostate Cancer Drug
Bayer (BAYRY - Free Report) announced the submission of a supplemental new drug application (sNDA) to the FDA for darolutamide.
The sNDA is seeking approval of darolutamide, in combination with androgen deprivation therapy (ADT), in patients with metastatic hormone-sensitive prostate cancer (mHSPC).
Darolutamide is an oral androgen receptor inhibitor (ARi) with a distinct chemical structure that binds to the androgen receptor with high affinity and exhibits strong antagonistic activity. It inhibits the receptor function and the growth of prostate cancer cells while minimizing side effects.
Year to date, shares of Bayer have lost 8.8% against the industry’s growth of 21.6%.
Image Source: Zacks Investment Research
BAYRY’s Clinical Program for Darolutamide
The submission is based on positive results from the phase III ARANOTE study, which showed that darolutamide plus ADT significantly reduced the risk of radiological progression or death by 46% compared to placebo plus ADT in patients with mHSPC.
Darolutamide is already approved under the brand name Nubeqa for the treatment of mHSPC in combination with ADT and docetaxel in several countries. The compound is also approved in combination with ADT for the treatment of patients with non-metastatic castration-resistant prostate cancer (nmCRPC) who are at high risk of developing metastatic disease in more than 85 countries around the world.
Darolutamide plus ADT now has positive data both with and without docetaxel based on two pivotal phase III studies in patients with mHSPC.
Bayer stated that sales of Nubeqa exceeded 1 billion euros year to date in September 2024.
Prostate cancer is the second most common cancer in men and the fifth most common cause of cancer-induced death in men worldwide. A potential approval of darolutamide for a third indication should boost its sales.
BAYRY is also evaluating darolutamide across various stages of prostate cancer in a broad development program.
The program includes the phase III ARASTEP trial evaluating darolutamide plus ADT compared to ADT alone in hormone-sensitive high-risk biochemical recurrence (BCR) prostate cancer patients who have a positive PSMA PET/CT at baseline and no evidence of metastatic disease by conventional imaging.
Bayer is also evaluating darolutamide in the collaborative phase III DASL-HiCaP trial led by the Australian and New Zealand Urogenital and Prostate Cancer Trials Group. The study evaluates darolutamide as an adjuvant treatment for localized prostate cancer with a very high risk of recurrence.
Bayer’s Efforts to Strengthen Pharma Business
Bayer is looking to strengthen its pharmaceutical portfolio amid generic competition for Xarelto.
Sales in the Pharmaceuticals Division increased 4.5% to €4.6 billion in the second quarter of 2024, driven by the strong performance of the cancer drug Nubeqa and chronic kidney disease drug Kerendia. Eylea also continues to perform well.
Bayer’s prostate cancer franchise includes two approved products — Nubeqa and Xofigo. It also has several candidates in its pipeline.
Bayer is working on the label expansion of its approved drugs and simultaneously developing new drugs.
Earlier in the month, Bayer announced that The European Medicines Agency has approved the pre-filled syringe for the administration of Eylea 8mg in the European Union. The approved indications are neovascular age-related macular degeneration and diabetic macular edema (DME).
Eylea 8 mg has been developed to reduce the disease burden and extend treatment intervals with comparable efficacy and safety to the standard-of-care drug Eylea 2 mg.
Eylea 8 mg is approved as Eylea HD in the United States. It is being jointly developed by Bayer and Regeneron Pharmaceuticals (REGN - Free Report) .
Regeneron maintains exclusive rights to Eylea 2 mg (aflibercept 2 mg) and Eylea HD in the United States. Bayer has licensed exclusive marketing rights outside the United States, where the companies equally share the profits from the sales of Eylea 2 mg and Eylea 8 mg following any regulatory approval.
BAYRY’s Zacks Rank & Stocks to Consider
BAYRY currently carries a Zacks Rank #3 (Hold). A couple of better-ranked large-cap pharma companies are Eli Lilly (LLY - Free Report) and Pfizer (PFE - Free Report) . While LLY sports a Zacks Rank #1 (Strong Buy), PFE carries a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
Estimates for Eli Lilly’s 2024 earnings have risen from $13.79 to $16.49 per share over the past 60 days. For 2025, the bottom-line estimate has risen from $19.44 to $23.97 over the same timeframe. Year to date, Lilly’s shares have risen 51.8%.
Estimates for PFE’s 2024 earnings have risen from $2.38 to $2.62 per share over the past 60 days. For 2025, the bottom-line estimate has risen from $2.74 to $2.85 over the same time frame.