• The FDA approved Bayer AG's (OTC: BAYRY) supplemental marketing application for Nubeqa (darolutamide) with docetaxel for metastatic hormone-sensitive prostate cancer (mHSPC).

• The approval is based on the results of Phase 3 ARASENS trial that demonstrated a reduction in the risk of death by 32% in Nubeqa plus androgen deprivation therapy and docetaxel compared to ADT and docetaxel.

• Nubeqa plus ADT and docetaxel also resulted in a statistically significant delay in time to pain progression.

• The recommended darolutamide dose for mHSPC is 600 mg (two 300 mg tablets) taken orally, twice daily, with food until unacceptable toxicity or disease progression.

• Docetaxel, 75 mg/m2 intravenously, is administered every three weeks for up to 6 cycles. The first dose of docetaxel should be administered within six weeks after starting darolutamide treatment.

• In 2019, the FDA approved Nubeqa for non-metastatic castration-resistant prostate cancer (nmCRPC), receiving a concomitant gonadotropin-releasing hormone analog or analog had a bilateral orchiectomy.

• Price Action: BAYRY shares closed lower by 7.09% at $13.63 on Friday.

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