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.


 

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This article originally published on Zacks Investment Research (zacks.com).

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