FDA Grants Priority Review to Bayer's Lynkuet for Vasomotor Symptom Indication

Bayer AG (BAYN.DE, BAY.MI, BYR.L) said the U.S. Food and Drug Administration accepted its supplemental New Drug Application and granted Priority Review designation for Lynkuet, an investigational treatment for moderate to severe vasomotor symptoms in women undergoing endocrine therapy. The designation shortens the FDA's review target to six months from the standard 10-month period, potentially accelerating U.S. market entry for the therapy. Financial terms and a decision date were not disclosed. Vasomotor symptoms, commonly known as hot flashes, are a frequent side effect of endocrine therapy used in hormone-sensitive cancers. Bayer has not released clinical trial data supporting the filing.