Although January 2020 was a fairly slow month for PDUFA dates for the U.S. Food and Drug Administration, February has a stronger schedule.

The U.S. Food and Drug Administration accepted Alnylam Pharmaceuticals Inc.’s New Drug Application for givosiran – an investigational RNAi therapeutic targeting aminolevulinic acid synthase 1 in development for the treatment of acute hepatic porphyria – and granted Priority Review for the NDA.

Cambridge, Mass.-based Alnylam Pharmaceuticals indicated that the company’s ENVISION Phase III trial of givosiran was positive for acute hepatic porphyria (AHP).

Despite releasing positive data on the company’s Phase III ENVISION trial, Alnylam Pharmaceuticals stock dropped 7.5 percent.