Latest news with #Lynkuet
Yahoo
6 days ago
- Business
- Yahoo
Bayer Wins Hormone-Free Treatment Approval for Women in the UK
Bayer BAYRY announced that it has won approval for pipeline drug elinzanetant in the UK for the treatment of moderate to severe vasomotor symptoms (VMS or hot flashes) associated with menopause. The Medicines and Healthcare products Regulatory Agency, a regulatory authority in the UK, has authorized the use of elinzanetant, under the brand name Lynkuet for the above-mentioned indication. Year to date, shares of Bayer have rallied 67% compared to the industry's gain of 2.7%. Image Source: Zacks Investment Research Elinzanetant is the first dual neurokinin (NK)-targeted therapy (NK-1 and NK- 3 receptor antagonist), which has been globally developed for the treatment of moderate to severe VMS associated with menopause or endocrine therapy for breast cancer, administered orally once daily. The marketing authorization in the UK marks the drug's first global approval. The approval was based on positive results from the late-stage studies OASIS-1, OASIS-2, and OASIS-3, which evaluated the efficacy and safety profile of elinzanetant. Results from the study showed that elinzanetant met all primary endpoints in all three studies and demonstrated a favorable safety profile. We note that elinzanetant is under regulatory review in the United States, countries of the European Union and other markets around the world. The approval of this hormone-free treatment is not only a transformative therapeutic advance for millions of women worldwide but also a compelling growth catalyst for Bayer's pharmaceutical division. As the first drug targeting both NK-1 and NK-3 receptors, it sidesteps the risks and contraindications associated with estrogen therapy, making it an attractive option for millions, including breast cancer survivors or women avoiding hormone-based interventions. Bayer's new products, such as Nubeqa and Kerendia, continue to maintain their impressive momentum in the Pharmaceutical division and offset the negative impact of a decline in Xarelto sales. The company is working to expand the labels of these key drugs, which should boost its top-line growth. Last month, the FDA expanded Nubeqa's label for a third indication for patients with advanced prostate cancer. The successful development of additional drugs is imperative for Bayer amid multiple challenges. BAYRY expects to launch two new drugs — elinzanetant and acoramidis, a drug for the treatment of a certain type of heart disease. The company also aims to strengthen its pharmaceutical pipeline. In 2021, Bayer acquired a clinical-stage biopharmaceutical company, Vividion Therapeutics, to expand into precision small-molecule therapeutics, primarily in oncology and immunology. BAYRY has expanded its pipeline in new modalities of cell therapy through the acquisition of BlueRock, and in gene therapy, through the AskBio buyout. BAYRY currently carries a Zacks Rank #1 (Strong Buy). A couple of other top-ranked stocks in the large-cap pharma sector are Novartis NVS and Johnson & Johnson JNJ, both carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today's Zacks #1 Rank stocks here. The Zacks Consensus Estimate for Novartis' 2025 earnings per share (EPS) has risen from $8.78 to $8.92 over the past 60 days. EPS estimates for 2026 have jumped 20 cents to $9.27 during the said timeframe. The stock has risen 30.2% so far this year. J&J's EPS estimate for 2025 has risen from $10.60 to $10.64 over the past 60 days, while that for 2026 has increased from $10.98 to $11.07 over the same timeframe. 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 Novartis AG (NVS) : Free Stock Analysis Report Johnson & Johnson (JNJ) : Free Stock Analysis Report Bayer Aktiengesellschaft (BAYRY) : Free Stock Analysis Report This article originally published on Zacks Investment Research ( Zacks Investment Research Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Globe and Mail
11-07-2025
- Business
- Globe and Mail
Bayer Wins Hormone-Free Treatment Approval for Women in the UK
Bayer BAYRY announced that it has won approval for pipeline drug elinzanetant in the UK for the treatment of moderate to severe vasomotor symptoms (VMS or hot flashes) associated with menopause. The Medicines and Healthcare products Regulatory Agency, a regulatory authority in the UK, has authorized the use of elinzanetant, under the brand name Lynkuet for the above-mentioned indication. Year to date, shares of Bayer have rallied 67% compared to the industry 's gain of 2.7%. More on Bayer's Elinzanetant Elinzanetant is the first dual neurokinin (NK)-targeted therapy (NK-1 and NK- 3 receptor antagonist), which has been globally developed for the treatment of moderate to severe VMS associated with menopause or endocrine therapy for breast cancer, administered orally once daily. The marketing authorization in the UK marks the drug's first global approval. The approval was based on positive results from the late-stage studies OASIS-1, OASIS-2, and OASIS-3, which evaluated the efficacy and safety profile of elinzanetant. Results from the study showed that elinzanetant met all primary endpoints in all three studies and demonstrated a favorable safety profile. We note that elinzanetant is under regulatory review in the United States, countries of the European Union and other markets around the world. The approval of this hormone-free treatment is not only a transformative therapeutic advance for millions of women worldwide but also a compelling growth catalyst for Bayer's pharmaceutical division. As the first drug targeting both NK-1 and NK-3 receptors, it sidesteps the risks and contraindications associated with estrogen therapy, making it an attractive option for millions, including breast cancer survivors or women avoiding hormone-based interventions. BAYRY's Efforts to Strengthen Pharma Business Bayer's new products, such as Nubeqa and Kerendia, continue to maintain their impressive momentum in the Pharmaceutical division and offset the negative impact of a decline in Xarelto sales. The company is working to expand the labels of these key drugs, which should boost its top-line growth. Last month, the FDA expanded Nubeqa's label for a third indication for patients with advanced prostate cancer. The successful development of additional drugs is imperative for Bayer amid multiple challenges. BAYRY expects to launch two new drugs — elinzanetant and acoramidis, a drug for the treatment of a certain type of heart disease. The company also aims to strengthen its pharmaceutical pipeline. In 2021, Bayer acquired a clinical-stage biopharmaceutical company, Vividion Therapeutics, to expand into precision small-molecule therapeutics, primarily in oncology and immunology. BAYRY has expanded its pipeline in new modalities of cell therapy through the acquisition of BlueRock, and in gene therapy, through the AskBio buyout. Bayer's Zacks Rank & Other Key Picks BAYRY currently carries a Zacks Rank #1 (Strong Buy). A couple of other top-ranked stocks in the large-cap pharma sector are Novartis NVS and Johnson & Johnson JNJ, both carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today's Zacks #1 Rank stocks here. The Zacks Consensus Estimate for Novartis' 2025 earnings per share (EPS) has risen from $8.78 to $8.92 over the past 60 days. EPS estimates for 2026 have jumped 20 cents to $9.27 during the said timeframe. The stock has risen 30.2% so far this year. J&J's EPS estimate for 2025 has risen from $10.60 to $10.64 over the past 60 days, while that for 2026 has increased from $10.98 to $11.07 over the same timeframe. #1 Semiconductor Stock to Buy (Not NVDA) The incredible demand for data is fueling the market's next digital gold rush. As data centers continue to be built and constantly upgraded, the companies that provide the hardware for these behemoths will become the NVIDIAs of tomorrow. One under-the-radar chipmaker is uniquely positioned to take advantage of the next growth stage of this market. It specializes in semiconductor products that titans like NVIDIA don't build. It's just beginning to enter the spotlight, which is exactly where you want to be. See This Stock Now for Free >> 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 Novartis AG (NVS): Free Stock Analysis Report Johnson & Johnson (JNJ): Free Stock Analysis Report Bayer Aktiengesellschaft (BAYRY): Free Stock Analysis Report
Telegraph
08-07-2025
- Health
- Telegraph
Non-HRT treatment for menopausal hot flushes approved
A treatment for menopausal hot flushes has been approved by medicine watchdogs. UK regulators have become the first in the world to approve the non-hormonal treatment, which is taken as a daily pill. Trials have found that elinzanetant (brand name Lynkuet) can cut flushes by two thirds and help to ease night sweats. Hot flushes are the most common symptom of menopause. Hormone replacement therapy is the most common form of medication used to combat menopausal symptoms. While HRT has become increasingly popular, many women do not want hormonal treatments which increase risk of cancer and some are not suitable for them. The new drug, now approved by the Medicines and Healthcare products Regulatory Agency (MHRA) is the first dual-action, non-hormonal pill to address both hot flushes and sleep problems. It has been licensed for the treatment of moderate to severe vasomotor symptoms (hot flushes) associated with the menopause. When oestrogen levels drop during menopause, certain brain cells become overactive and interrupt the body's ability to control temperature, which leads to hot flushes and night sweats. Elinzanetant is a new non-hormonal medication which works by calming these signals in the brain, helping bring the body's temperature control back into balance. It may also help improve sleep problems that often come with menopause. The medicine manufactured by Bayer is administered in oral tablet form. Julian Beach, MHRA interim executive director of healthcare quality and access, said: 'Hot flushes and night sweats associated with menopause can have a significant negative impact on quality of life. 'We are therefore pleased to announce our approval of elinzanetant, which has met the MHRA's standards for safety, quality and effectiveness. 'Elinzanetant offers a non-hormonal alternative for those who may not be able to, or prefer not to, take hormone-based therapies. As with all licensed medicines, we will continue to monitor its safety closely as it becomes more widely used.' Elinzanetant's approval is based on results from the Oasis clinical trials, which involved more than 1,400 women aged 40 to 65 across several countries. These studies showed that taking a daily 120mg tablet of elinzanetant significantly reduced the number and intensity of hot flushes and night sweats over 26 to 52 weeks, compared with a placebo. At 12 weeks, hot flushes were reduced by around two thirds, the research found. By week 26, more than 80 per cent of women on elinzanetant achieved at least a 50 per cent reduction in hot flush frequency. In the past five years, the number of women taking HRT has doubled, with an estimated 2.6 million women using it in 2023-24. Much of the surge is attributed to the 'Davina' effect after Davina McCall spoke about her own experiences of menopause, and led campaigns about the symptoms and potential benefits of HRT. The numbers on the therapy had fallen sharply, after a landmark trial which was later found to have overstated the risks of breast cancer.
Rhyl Journal
08-07-2025
- Health
- Rhyl Journal
Hot flush pill gets green light for UK use
The Medicines and Healthcare products Regulatory Agency (MHRA) said it is the first regulator in the world to approve elinzanetant, also known as Lynkuet. The treatment, made by Bayer, can be given to women who have vasomotor symptoms, also known as hot flushes, as an alternative to hormone replacement therapy (HRT). HRT can help relieve most menopause and perimenopause symptoms, including hot flushes. But not all patients want or are able to take hormone treatments. At present elinzanetant is not available on the NHS but the green light from the MHRA means that it can be purchased privately in the UK. It is to be considered by the NHS spending watchdog, the National Institute for Health and Care Excellence. Hot flushes and night sweats are one of the most common symptoms of menopause. It is understood that as oestrogen levels decline around menopause, the body's temperature regulation system can be disrupted when certain brain cells become overactive. The new treatment, which is a non-hormonal medication, works by calming these signals in the brain. Clinical trial data showed that the drug was safe and well tolerated and reduced hot flushes compared with a dummy drug, also known as a placebo. You may not have reached #menopause if you're experiencing headaches, night sweats, weight gain, anxiety and depression – but you may be #perimenopausal. Take a look on our website for more information 👉 — Patient (@patient) May 22, 2023 It was also linked to fewer sleep disturbances and women taking it reported a better quality of life compared with those taking the placebo. 'Hot flushes and night sweats associated with menopause can have a significant negative impact on quality of life,' said Julian Beach, the MHRA's interim executive director of healthcare quality and access. 'We are therefore pleased to announce our approval of elinzanetant, which has met the MHRA's standards for safety, quality and effectiveness. 'Elinzanetant offers a non-hormonal alternative for those who may not be able to, or prefer not to, take hormone-based therapies. 'As with all licensed medicines, we will continue to monitor its safety closely as it becomes more widely used.' Women usually go through the menopause when they are aged between 45 and 55, though it can start sooner. During the menopause a woman's periods stop due to lower hormone levels. Menopause and perimenopause can cause symptoms including anxiety, mood swings, brain fog, hot flushes and irregular periods.
The Independent
08-07-2025
- Health
- The Independent
Hot flush pill for menopausal women approved for use in UK
Women in the UK will soon have access to a new daily pill designed to alleviate hot flushes during menopause, following its approval for use. The Medicines and Healthcare products Regulatory Agency (MHRA) has become the first global regulator to give the green light to elinzanetant, also known as Lynkuet. Developed by Bayer, this treatment offers an alternative to hormone replacement therapy (HRT) for those experiencing vasomotor symptoms, commonly known as hot flushes. HRT is currently a widely used option for managing various menopause and perimenopause symptoms, including these disruptive flushes. But not all patients want or are able to take hormone treatments. At present elinzanetant is not available on the NHS but the green light from the MHRA means that it can be purchased privately in the UK. It is to be considered by the NHS spending watchdog, the National Institute for Health and Care Excellence. Hot flushes and night sweats are one of the most common symptoms of menopause. It is understood that as oestrogen levels decline around menopause, the body's temperature regulation system can be disrupted when certain brain cells become overactive. The new treatment, which is a non-hormonal medication, works by calming these signals in the brain. Clinical trial data showed that the drug was safe and well tolerated and reduced hot flushes compared with a dummy drug, also known as a placebo. It was also linked to fewer sleep disturbances and women taking it reported a better quality of life compared with those taking the placebo. 'Hot flushes and night sweats associated with menopause can have a significant negative impact on quality of life,' said Julian Beach, the MHRA's interim executive director of healthcare quality and access. 'We are therefore pleased to announce our approval of elinzanetant, which has met the MHRA's standards for safety, quality and effectiveness. 'Elinzanetant offers a non-hormonal alternative for those who may not be able to, or prefer not to, take hormone-based therapies. 'As with all licensed medicines, we will continue to monitor its safety closely as it becomes more widely used.' Women usually go through the menopause when they are aged between 45 and 55, though it can start sooner. During the menopause a woman's periods stop due to lower hormone levels. Menopause and perimenopause can cause symptoms including anxiety, mood swings, brain fog, hot flushes and irregular periods.
