Latest news with #elinzanetant
Yahoo
13-07-2025
- 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
Reuters
09-07-2025
- Health
- Reuters
Health Rounds: Experimental Bayer drug eases menopause-like symptoms from breast cancer therapy
July 9 (Reuters) - (This is an excerpt of the Health Rounds newsletter, where we present latest medical studies on Tuesdays and Thursdays. To receive the full newsletter in your inbox for free sign up here.) The hot flashes and night sweats that plague breast cancer survivors during years-long hormone-suppressing therapy are eased by an experimental non-hormonal drug being developed by Bayer ( opens new tab, according to results from a late-stage trial. The participants in the trial – similar to two-thirds of breast cancer patients overall - had tumors that use the hormones estrogen and progesterone to grow. The goal of so-called endocrine therapy is to block those hormones, which reproduces the uncomfortable menopause symptoms. The most effective way to relieve these symptoms in healthy women is to replace the hormones, which is not feasible when tumors use the hormones to grow. In a year-long trial involving 474 breast cancer patients experiencing daily hot flashes due to hormone-suppressing therapy, 316 received Bayer's elinzanetant and 158 received a placebo. Within three months, more than 70% of those on elinzanetant reported at least a 50% reduction in moderate-to-severe hot flashes, compared to about 36% of the placebo group, the researchers reported at a recent meeting of cancer doctors and in The New England Journal of Medicine, opens new tab. The Bayer drug also significantly improved sleep quality and menopausal quality of life by week 12. 'It is important to treat vasomotor symptoms because they can negatively impact quality of life and lead to women prematurely stopping their breast cancer treatment,' said study leader Dr. Fatima Cardoso of the Champalimaud Clinical Center in Lisbon. Elinzanetant belongs to a new class of drugs called neurokinin receptor antagonists that target the neurobiological mechanisms in the brain involved in hot flashes and night sweats. The U.S. Food and Drug Administration recently approved an Astellas Pharma (4503.T), opens new tab drug from the class under the brand name Vezoah for easing symptoms of menopause. It is not approved for treating breast cancer patients, so that use would be off-label, the study authors noted. Doctors can prescribe any approved medicine as they see fit, but companies can only promote them for approved uses. An editorial, opens new tab published with the study notes that up to 90% of women with early breast cancer treated with endocrine therapy experience hot flashes and other vasomotor symptoms, which may impact their survival if the symptoms lead them to quit taking the medications. In one large study of breast cancer survivors, half the participants reported non-adherence to endocrine therapy, the editorial says. Bayer is awaiting approval of elinzanetant from the FDA and the European Medicines Agency. Cases of type 1 diabetes caused by cancer immunotherapy drugs can be controlled – and even reversed – by treatment with already approved medicines for autoimmune conditions like psoriasis and rheumatoid arthritis, laboratory studies suggest. Type 1 diabetes, in which the body mistakenly attacks and destroys insulin-producing cells in the pancreas, occurs in 1% to 2% of patients receiving immunotherapies known as checkpoint inhibitors, such as Merck's (MRK.N), opens new tab Keytruda and Bristol Myers Squibb's (BMY.N), opens new tab Opdivo. The condition is often permanent, requiring insulin therapy for life. With the increased use of the blockbuster cancer drugs, 'preventing long-term autoimmune damage is becoming a critical part of survivorship care,' study leader Dr. Melissa Lechner of the David Geffen School of Medicine at UCLA said in a statement. 'This is one of the first times we've found a way to intervene in these toxicities in a meaningful way,' she added. Her team identified a new group of immune cells called CD4+ T follicular helper cells, or Tfh cells, which produce signaling molecules called IL-21 and IFN-gamma that fuel the immune attack on the pancreas. In experiments in mice, the researchers found that a class of drugs known as JAK inhibitors, which block the IL-21 and IFN-gamma pathways, not only blocked the effects of the two signaling molecules but also reduced the number of Tfh cells and, in some cases, restored normal blood sugar levels. The results were reported in JCI Insight, opens new tab. Available JAK inhibitors include Pfizer's (PFE.N), opens new tab Xeljanz, Rinvoq from AbbVie (ABBV.N), opens new tab and Eli Lilly's (LLY.N), opens new tab Olumiant. 'This is the first study to identify Tfh cells and the IL-21/IFN-gamma pathway as key drivers of checkpoint inhibitor–induced type 1 diabetes,' said Lechner. 'Importantly, we show that this pathway can be therapeutically targeted with a drug that is already FDA-approved and widely available without weakening the immune system's ability to fight cancer.' (To receive the full newsletter in your inbox for free sign up here)
The Independent
08-07-2025
- Health
- The Independent
HRT-alternative for women experiencing hot flushes gets green light
The Medicines and Healthcare products Regulatory Agency (MHRA) in the UK has approved elinzanetant, a new non-hormonal daily pill for menopausal hot flushes, making it the first global regulator to do so. Developed by Bayer, elinzanetant offers an alternative to hormone replacement therapy (HRT) for women experiencing vasomotor symptoms, commonly known as hot flushes. The medication works by calming specific brain signals that become overactive due to declining oestrogen levels during menopause, which disrupt the body's temperature regulation. Clinical trials demonstrated that the drug is safe, well-tolerated, effectively reduces hot flushes, improves sleep, and enhances the quality of life for women compared to a placebo. While not yet available on the NHS, the MHRA's approval means elinzanetant can be purchased privately in the UK and will be considered by the National Institute for Health and Care Excellence (NICE).
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.
