Bayer to spotlight Nubeqa data at AUA amid push for expanded use

Bayer AG (FWB: BAYN) is set to present new data for Nubeqa (darolutamide) in prostate cancer at the upcoming American Urological Association (AUA) Annual Meeting taking place in Las Vegas from April 26-29, 2025.

Originally discovered by Finland’s Orion Oyj (NASDAQ: ORNBV), Nubeqa—an androgen receptor inhibitor—is now co-developed and marketed globally in partnership with Bayer, which leads on clinical trials and commercial rollout. Orion, in turn, receives royalties and milestone payments, handles manufacturing, and retains promotional rights in certain European markets.

Approved by the U.S. Food and Drug Administration in August 2022 for use alongside chemotherapy and hormone therapy in treating metastatic hormone-sensitive prostate cancer (mHSPC), Nubeqa marked a meaningful advance for patients seeking more intensive treatment options. But the partnership is now targeting an even broader market.

In September 2024, Bayer filed for FDA approval to expand Nubeqa’s use to a chemo-free regimen—pairing it with hormone therapy alone. Backed by data from the Phase III ARANOTE trial, which showed a 46% drop in disease progression or death compared to standard treatment, the FDA accepted the application for review in November. A regulatory decision is expected by mid-2025.

Analysts forecast Bayer’s revenue from Nubeqa to jump from €1.5 billion in 2024 to €2 billion in 2025, and eventually peak at €3.2 billion by 2029—by then, accounting for nearly a fifth of the pharma group’s pharmaceutical revenue. Orion’s upside is equally significant: the drug is expected to contribute nearly 30% of its total revenue by 2025, with sales approaching €500 million, up from €368 million in 2024.