Precision BioSciences, Inc. announced on April 15, 2025, that the U.S. Food and Drug Administration (FDA) granted Fast Track designation for PBGENE-HBV. This is the company’s lead wholly-owned in vivo gene editing program, designed to cure chronic hepatitis B by eliminating cccDNA and inactivating integrated HBV DNA.
The Fast Track designation underscores the urgent need for improved treatment options for patients living with chronic hepatitis B. This classification can facilitate more frequent meetings and communications with the FDA and potentially allow for a rolling review of any marketing approval application.
Precision BioSciences 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 company anticipates sharing updates on the full low-dose cohort and data from higher dose levels throughout 2025, building on initial encouraging safety and antiviral activity.
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