Galidesivir, not berotralstat, will be the BCRX catalyst
Oral berotralstat is soon likely to gain approval in three regions - Japan, the U.S., and Europe - for the treatment of HAE. In Japan, a new drug application for berotralstat is currently being reviewed by the Pharmaceuticals and Medical Devices Agency, and BioCryst (BCRX) expects approval in H2 2020. In the U.S., the Food and Drug Administration (FDA) has set a Prescription Drug User Fee Act (PDUFA) date of December 3, 2020. BCRX's Chief Medical Officer, William P. Sheridan, says of the FDA approval