FDA Grants Accelerated Approval to Bayer’s HYRNUO for Advanced HER2-Mutant Lung Cancer

The FDA has granted accelerated approval to Bayer's HYRNUO™ (sevabertinib) for treating advanced HER2-mutant lung cancer. This approval is for adult patients with locally advanced or metastatic non-squamous non-small cell lung cancer with HER2 mutations, who have previously received systemic therapy. Sevabertinib is a tyrosine kinase inhibitor, and the approval follows Priority Review and Breakthrough Therapy Designation. Bayer AG announced this on November 20, 2025.

Bayer Wins EU Approval for Lynkuet to Treat Menopausal and Breast Cancer Therapy Hot Flashes

Bayer AG has received EU approval for Lynkuet™ (elinzanetant), a hormone-free therapy for treating moderate to severe vasomotor symptoms (VMS) like hot flashes associated with menopause or breast cancer therapy. The approval follows positive results from the OASIS Phase III clinical program, showing significant reduction in VMS frequency and severity with a favorable safety profile. Lynkuet™ offers a new treatment option for affected women.

Bayer Aktiengesellschaft Reports Earnings Results for the Third Quarter and Nine Months Ended September 30, 2025

Bayer Aktiengesellschaft reported its earnings for Q3 and the first nine months of 2025. Q3 sales were EUR 9,660 million, down from EUR 9,968 million year-over-year, with a net loss of EUR 963 million compared to a loss of EUR 4,183 million last year. For the nine months, sales totaled EUR 34,137 million, slightly down from EUR 34,877 million, but net income improved to EUR 137 million from a loss of EUR 2,217 million. Basic and diluted earnings per share from continuing operations were EUR 0.14, recovering from losses of EUR 2.26 last year.

Bayer's adjusted EBITDA for the third quarter rose nearly 21%, beating expectations

German pharmaceutical giant Bayer announced its third-quarter results, with adjusted EBITDA rising 20.8% to €1.51 billion, exceeding market expectations of €1.29 billion. Sales fell 3.1% year-on-year to €9.66 billion, below expectations. CEO Bill Anderson is committed to rebuilding investor trust and has promised to manage legal risks by the end of next year while implementing efficiency improvement plans. Bayer's stock price has risen over 40% this year, but it is still below pre-Monsanto acquisition levels

In the third quarter, Bayer's adjusted EBITDA was €1.51 billion, while the market estimate was €1.29 billion