FDA accepts New Drug Application, gives Priority Review for Bayer prostate med

Bayer today announced the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) and granted Priority Review to darolutamide for the treatment of non-metastatic castration-resistant prostate cancer (nmCRPC). The NDA and Priority Review status were based on data from the Phase III ARAMIS trial in men with nmCRPC.¹ Darolutamide is an investigational, non-steroidal androgen receptor (AR) antagonist with a distinct chemical structure that binds to the receptor, inhibiting the growth of prostate cancer cells.

https://www.biospace.com/article/releases/u-s-fda-accepts-new-drug-application-and-grants-priority-review-for-darolutamide/