BAYRY Bayer AG (ADR)

$BAYRY Bayer's drug business just had its second FDA win in eleven days. On Sept 28 the FDA granted priority review to Lynkuet (elinzanetant) for moderate to severe hot flashes in women on endocrine therapy for HR-positive breast cancer. There are currently no FDA-approved pharmacologic options for that indication, which is what priority review is supposed to flag: genuine unmet need. The package rests on OASIS-4: 474 women across 90 sites, all primary and secondary endpoints met, data published in the NEJM in June 2025. Lynkuet was first approved in Oct 2025 for menopausal hot flashes, then in the EU last November. Eleven days before this review, Kerendia was approved as the first new treatment in 30 years for CKD with type 1 diabetes. Label expansion is becoming a rhythm.

Bayer said Friday that its pharmaceutical division will invest $2.2 billion in a new manufacturing facility in New Albany, Ohio, as part of its strategy to expand production and increase revenue in the U.S. market. The project is expected to create around 600 permanent jobs in New Albany, along with approximately 1,500 temporary positions during construction. Bayer said its prescription-drug business has increased the share of global revenue generated in the U.S. to 35% from 20% in 2018, and the company aims to double its U.S. sales by the end of the decade. The new facility will support several key products, including Kerendia for chronic kidney disease, Nubeqa for prostate cancer and asundexian, an experimental drug candidate designed to prevent strokes. The investment is intended to strengthen Bayer’s domestic manufacturing footprint while supporting future growth in its pharmaceutical portfolio. $BAYRY

$BAYRY nearly 1.50 off in 3 days 😮‍💨 I guess we're back to the witch-hunt 3 months after the end was in sight.