Lynkuet's Entry into the European Market

Bayer AG's BAYN Lynkuet (active ingredient: elinzanetant), a new drug for treating menopausal vasomotor symptoms, received marketing authorization from the European Medicines Agency EMA on November 17, 2025. This approval follows the FDA approval on October 24, 2025, marking the completion of all major regulatory hurdles for entry into global markets. Lynkuet is an NK1,3 receptor antagonist that directly acts on the thermoregulatory center in the brain, alleviating hot flashes and night sweats experienced by menopausal women. It is an innovative non-hormonal therapy and may also serve as a new alternative for patients undergoing adjuvant endocrine therapy for breast cancer who cannot use hormone replacement therapy HRT.

Clinical Efficacy Demonstrated in Phase 3 OASIS Trials

This European approval is based on the results of the global Phase 3 OASIS 1, 2, 3, and 4 trials. In studies conducted on postmenopausal women, Lynkuet statistically significantly reduced the frequency and severity of hot flashes compared to placebo and also demonstrated excellent results in improving sleep disturbances. Furthermore, the OASIS 4 trial in breast cancer patients demonstrated that it can safely control heat-related symptoms associated with hormone therapy, addressing a significant unmet medical need. This approval, based on robust clinical data, is expected to be a strong differentiator against competing products.

Competition in the $2 Billion VMS Market

The global market for menopausal vasomotor symptom VMS treatments is estimated at $2 billion, and Bayer expects peak annual sales of Lynkuet to be approximately €1 billion. Astellas Pharma's Veozah (active ingredient: fezolinetant), an NK3 receptor antagonist, is currently on the market and is a major competitor. However, Lynkuet has the potential to gain a competitive advantage in the area of sleep quality improvement due to its differentiated mechanism of action, which blocks both NK-3 and NK-1 receptors. This clinical strength will be a key factor in determining the speed at which it is listed for reimbursement in each European country.

Diversification of Portfolio through the Acquisition of KaNDy

In August 2020, Bayer acquired KaNDy Therapeutics, a UK-based biotech company, for a total of $1.25 billion, gaining global rights to elinzanetant. The agreement included an upfront payment of $425 million, milestone payments of $450 million upon approval and launch, and commercial milestone payments of $375 million based on future sales performance. This European approval is considered a successful venture investment case that demonstrates Bayer's ability to identify promising drug candidates in Phase 2 development and successfully commercialize them. It highlights Bayer's strong new drug development vision and global regulatory capabilities.

European Reimbursement Negotiations and Future Milestones

Following the final approval of Lynkuet, successful price negotiations with health authorities and reimbursement listing in each European country are essential for generating actual revenue. Given Bayer's somewhat stagnant overall revenue growth, the full launch of Lynkuet, which has the potential to be a high-margin blockbuster, will be a strong catalyst for further strengthening the company's financial fundamentals. Investors are paying close attention to the actual market penetration in Europe, the results of price negotiations, and the financial impact of additional milestones to be paid upon successful commercialization.