The FDA approved Lynkuet (elinzanetant) 60 mg capsules for the treatment of moderate to severe hot flashes due to menopause last week. Lynkuet is reportedly the first and only dual neurokinin (NK) targeted therapy, as it is both a neurokinin 1 (NK1) and neurokinin 3 (NK3) receptor antagonist.
The Bayer Cross at night. Credit: Bayer
Filling the gap of nonhormonal treatment options
According to UCLA Health, 75% of women in menopause will experience hot flashes, making them the most common symptom of the physiological process. However, fewer than half of those who experience hot flashes receive treatment. The approval of Lynkuet could be an important step towards closing that gap.
Lynkuet blocks the NK1 and NK3 receptors, which affect temperature regulation and may also have effects on mood and sleep. Other treatments for hot flashes include hormone therapy, often a safe and effective option as well as FDA-approved nonhormonal therapies including fezolinetant (Veozah), an NK3-only antagonist that launched in 2023, and paroxetine (Brisdelle), an SSRI. While HRT is the most popular treatment option, some women who have or are at high risk for types of breast and ovarian cancer may be advised to avoid such therapies. Lynkuet, a nonhormonal treatment, could be a new option for these patients.
In clinical trials, more than 70% of participants receiving the drug reported at least a 50% drop in the frequency of hot flashes after 12 weeks. At 26 weeks, more than 80% reported at least a 50% drop in the frequency of hot flashes. Some participants also reported less sleep disturbance. One of the receptors Lynkuet blocks may also independently regulate sleep as NK1 and NK3 are receptors that are expressed in hypothalamic sleep-wake circuits, but no study has been conducted on this effect.
“The FDA approval of Lynkuet is an important new option for women and providers who are treating moderate to severe hot flashes due to menopause,” said Yesmean Wahdan, Head of Medical Affairs USA & North America at Bayer, in a press release.
Lynkuet is expected to be available in the U.S. in Nov. 2025. It is currently also approved in Australia, Canada, the United Kingdom and Switzerland and is pending approval in the European Union.
Through the Lynkuet Access Savings & Support program (LASS), patients can connect with a healthcare provider to find the lowest cost and get their prescription from home. Eligible patients may receive the medicine at no cost through the Bayer U.S. Patient Assistance Foundation.
In the market
While its stock has been trading roughly flat over the past few days, Bayer stock is up 43.78% YTD. Although its share price was roughly two times higher in portions of 2022 as the company has grappled with factors ranging from Monsanto-based debt burden, glyphosate-based lawsuits, weakening agricultural segment revenue and pharma segment pressures, including the blood thinner Xarelto facing generic competition. The company reported quarter two sales at 10.739 billion euros (12.496 billion USD) this summer. Also in Q2, the company’s crop science sales increased by 2.2% to 4.788 billion euros, which the company credits to its corn seed products. In the pharmaceutical sector, sales of Nubeqa, a treatment for prostate cancer, were up 50.5%; sales for Kerendia, a treatment for chronic kidney disease associated with type 2 diabetes, rose 67.1%.
According to a compilation of analyst opinions by Analyst Consensus Target, Bayer’s revenue is expected to grow by 1.3% annually over the next three years. The company’s earnings are expected to reach 3.1 billion euros by Sept. 2028. The report values Bayer stock at 28.53 euro, meaning that its current price of 27.61 euros is undervalued.
Investments in women’s health have been increasing in recent years. Silicon Valley Bank (SVB) reported that women’s health investment hit $2.6 billion last year, up almost $1 billion from 2023.
“While 2025 may present challenges, the long-term potential of the sector is clear, and we expect continued investment focused on addressing the unmet healthcare needs for women,” said Raysa Bousleiman, co-author of the report and senior vice president for Investor Coverage in Life Science and Healthcare at SVB.
The company is expected to release its Quarter 3 report next month.
Bayer’s pharmaceutical products focus on cardiology, women’s health, oncology, hematology, ophthalmology and radiology. Bayer also has a portfolio of products for agriculture, including chemical and biological pest management products.
Filed Under: clinical trials, Obstetrics & gynecology
