Posted by Michael Wonder on 15 Apr 2025
Precision BioSciences receives US FDA fast track designation for PBGENE-HBV, a first in class gene editing therapy designed to eliminate the root cause of chronic hepatitis B
15 April 2025 - Precision BioSciences today announced that the US FDA has granted fast track designation for PBGENE-HBV, the Company’s lead wholly owned in vivo gene editing program designed to cure chronic hepatitis B by eliminating cccDNA, the key source of replicating hepatitis B virus, and inactivating integrated hepatitis B virus DNA in hepatocytes.
Precision is evaluating PBGENE-HBV in the on-going global Phase 1 ELIMINATE-B trial, with clinical investigation in the United States, Moldova, Hong Kong, New Zealand, and the United Kingdom.
