FDA grants priority review for Bayer Lynkuet in breast cancer endocrine therapy hot flashes indication

By Public Technologies
  • 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 Business Wire (Ref. ID: 20260925353226) on September 28, 2026, and is solely responsible for the information contained therein.

Capital.com is an execution-only brokerage platform and the content provided on the Capital.com website is intended for informational purposes only and should not be regarded as an offer to sell or a solicitation of an offer to buy the products or securities to which it applies. No representation or warranty is given as to the accuracy or completeness of the information provided.

The information provided does not constitute investment advice nor take into account the individual financial circumstances or objectives of any investor. Any information that may be provided relating to past performance is not a reliable indicator of future results or performance.

To the extent permitted by law, in no event shall Capital.com (or any affiliate or employee) have any liability for any loss arising from the use of the information provided. Any person acting on the information does so entirely at their own risk.

Any information which could be construed as “investment research” has not been prepared in accordance with legal requirements designed to promote the independence of investment research and as such is considered to be a marketing communication.