Precision's PBGENE-HBV Secures FDA Fast Track Designation For Chronic Hepatitis B Treatment

(RTTNews) - Precision BioSciences, Inc. (DTIL), Tuesday announced that the U.S. Food and Drug Administration has granted Fast Track designation for PBGENE-HBV, a first-in-class gene editing therapy designed to eliminate the root cause of chronic hepatitis B.

Currently, the company is evaluating PBGENE-HBV in the ongoing global Phase 1 ELIMINATE-B trial, with clinical investigation in the United States, Moldova, Hong Kong, New Zealand, and the United Kingdom.

The clinical stage gene editing company anticipates to share updates on the full low-dose cohort, including multiple dose administrations, and data from higher dose levels throughout 2025.

In the pre-market hours, Precision's stock is trading at $4.77, up 6.95 percent on the Nasdaq.