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BAYRY Obtains Approval for Hormone Free VMS Treatment Lynkuet in the EU
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Key Takeaways
Bayer gained approval for Lynkuet to treat moderate to severe vasomotor symptoms in the EU.
Approval is based on positive OASIS studies that met all primary and key secondary endpoints.
The nod broadens Bayer's portfolio and adds to momentum alongside Nubeqa and Kerendia.
Bayer (BAYRY - Free Report) obtained European Commission approval for elinzanetant for the treatment of moderate to severe vasomotor symptoms (VMS, also known as hot flashes) associated with menopause or caused by adjuvant endocrine therapy (AET) related to breast cancer.
The drug was approved under the brand name Lynkuet.
The approval of elinzanetant in the EU is based on the positive results from the late-stage OASIS program, comprising OASIS-1, -2, -3 and -4, which met all primary endpoints and key secondary endpoints in all four studies and demonstrated a favorable safety profile. Lynkuet’s approval broadens Bayer’s pharmaceutical portfolio.
Year to date, shares of Bayer have surged 62.1% compared with the industry’s gain of 14.3%.
Image Source: Zacks Investment Research
More on BAYRY’s Lynkuet
Elinzanetant is a dual neurokinin (NK)-targeted therapy (NK-1 and NK-3 receptor antagonist).
Per BAYRY, it is the only hormone-free treatment for moderate to severe VMS associated with menopause or caused by AET related to breast cancer.
VMS affects up to 80% of women during the menopausal transition. Endocrine therapy, an established treatment for women with HR+ breast cancer, can often result in VMS impacting quality of life and treatment adherence.
Approximately 40% of women report moderate to severe VMS in Europe. Lynkuet is already approved in the UK and the United States for the treatment of VMS associated with menopause.
BAYRY’s Efforts to Broaden Portfolio
Bayer beat on earnings in the third quarter, fueled by strong performance in Crop Science.
Bayer Aktiengesellschaft Price, Consensus and EPS Surprise
The Pharma business also maintains momentum. Bayer’s key drugs, Nubeqa for cancer and Kerendia for chronic kidney disease associated with type II diabetes, are fueling growth in its Pharmaceuticals division, making up for the decline in sales of oral anticoagulant Xarelto, which is co-developed with Johnson & Johnson (JNJ - Free Report) .
Xarelto is marketed by Johnson & Johnson in the United States. Bayer earns license revenues from JNJ for Xarelto sales in the United States.
Label expansion of key drugs and approval of additional drugs will further boost sales from this business.
Bayer is also working to expand the labels of Nubeqa and Kerendia, which, if successful, can further drive growth.
The approval of elinzanetant is a significant boost for the company.
Bayer is making good pipeline progress as well. The new drug application for investigational contrast agent, gadoquatrane, had been accepted for review in both the United States and China. Gadoquatrane is being developed for use in contrast-enhanced magnetic resonance imaging of the central nervous system and other body regions in adults and pediatric patients, including term neonates.
The company has expanded its pipeline in new modalities of cell therapy through the acquisition of BlueRock and in gene therapy through the acquisition of AskBio.
Bayer, together with its subsidiaries, BlueRock and AskBio, is developing preclinical and clinical cell and gene therapies for treating various diseases, including retinal disorders, congestive heart failure and Parkinson's disease.
Alkermes’ EPS estimates for 2025 have increased to $1.96 from $1.83, while those for 2026 have risen from $1.70 to $1.77 in the past 30 days. The stock has gained 2.2% year to date.
Alkermes’ earnings beat estimates in three of the trailing four quarters and missed the mark in one, delivering an average surprise of 4.58%.
In the past 60 days, estimates for Amicus Therapeutics’ 2025 EPS have increased to 34 cents from 31 cents. During the same time, EPS estimates for 2026 have decreased to 67 cents from 69 cents. Year to date, shares of FOLD have gained 1.8%.
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BAYRY Obtains Approval for Hormone Free VMS Treatment Lynkuet in the EU
Key Takeaways
Bayer (BAYRY - Free Report) obtained European Commission approval for elinzanetant for the treatment of moderate to severe vasomotor symptoms (VMS, also known as hot flashes) associated with menopause or caused by adjuvant endocrine therapy (AET) related to breast cancer.
The drug was approved under the brand name Lynkuet.
The approval of elinzanetant in the EU is based on the positive results from the late-stage OASIS program, comprising OASIS-1, -2, -3 and -4, which met all primary endpoints and key secondary endpoints in all four studies and demonstrated a favorable safety profile. Lynkuet’s approval broadens Bayer’s pharmaceutical portfolio.
Year to date, shares of Bayer have surged 62.1% compared with the industry’s gain of 14.3%.
Image Source: Zacks Investment Research
More on BAYRY’s Lynkuet
Elinzanetant is a dual neurokinin (NK)-targeted therapy (NK-1 and NK-3 receptor antagonist).
Per BAYRY, it is the only hormone-free treatment for moderate to severe VMS associated with menopause or caused by AET related to breast cancer.
VMS affects up to 80% of women during the menopausal transition. Endocrine therapy, an established treatment for women with HR+ breast cancer, can often result in VMS impacting quality of life and treatment adherence.
Approximately 40% of women report moderate to severe VMS in Europe. Lynkuet is already approved in the UK and the United States for the treatment of VMS associated with menopause.
BAYRY’s Efforts to Broaden Portfolio
Bayer beat on earnings in the third quarter, fueled by strong performance in Crop Science.
Bayer Aktiengesellschaft Price, Consensus and EPS Surprise
Bayer Aktiengesellschaft price-consensus-eps-surprise-chart | Bayer Aktiengesellschaft Quote
The Pharma business also maintains momentum. Bayer’s key drugs, Nubeqa for cancer and Kerendia for chronic kidney disease associated with type II diabetes, are fueling growth in its Pharmaceuticals division, making up for the decline in sales of oral anticoagulant Xarelto, which is co-developed with Johnson & Johnson (JNJ - Free Report) .
Xarelto is marketed by Johnson & Johnson in the United States. Bayer earns license revenues from JNJ for Xarelto sales in the United States.
Label expansion of key drugs and approval of additional drugs will further boost sales from this business.
Bayer is also working to expand the labels of Nubeqa and Kerendia, which, if successful, can further drive growth.
The approval of elinzanetant is a significant boost for the company.
Bayer is making good pipeline progress as well. The new drug application for investigational contrast agent, gadoquatrane, had been accepted for review in both the United States and China. Gadoquatrane is being developed for use in contrast-enhanced magnetic resonance imaging of the central nervous system and other body regions in adults and pediatric patients, including term neonates.
The company has expanded its pipeline in new modalities of cell therapy through the acquisition of BlueRock and in gene therapy through the acquisition of AskBio.
Bayer, together with its subsidiaries, BlueRock and AskBio, is developing preclinical and clinical cell and gene therapies for treating various diseases, including retinal disorders, congestive heart failure and Parkinson's disease.
BAYRY's Zacks Rank & Other Stocks to Consider
Bayer currently carries a Zacks Rank #2 (Buy).
A couple of other top-ranked stocks in the biotech sector are Alkermes (ALKS - Free Report) and Amicus Therapeutics (FOLD - Free Report) , each sporting a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
Alkermes’ EPS estimates for 2025 have increased to $1.96 from $1.83, while those for 2026 have risen from $1.70 to $1.77 in the past 30 days. The stock has gained 2.2% year to date.
Alkermes’ earnings beat estimates in three of the trailing four quarters and missed the mark in one, delivering an average surprise of 4.58%.
In the past 60 days, estimates for Amicus Therapeutics’ 2025 EPS have increased to 34 cents from 31 cents. During the same time, EPS estimates for 2026 have decreased to 67 cents from 69 cents. Year to date, shares of FOLD have gained 1.8%.