Bayer's Lynkuet Gets FDA Priority Review For Breast Cancer Use

Bayer’s supplemental NDA for Lynkuet won FDA acceptance with Priority Review for hot flashes tied to endocrine therapy in HR+ breast cancer. Lynkuet was first cleared in October 2025 for moderate-to-severe menopausal vasomotor symptoms. Filing relies on Phase III OASIS-4 data showing symptom reductions at weeks 4 and 12 versus placebo. Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Bayer AG published the original content used to generate this news brief via (Ref. ID: 20260925353226) on September 28, 2026, and is solely responsible for the information contained therein. (C)