Precision BioSciences' IND Application For PBGENE-HBV Gets FDA Clearance; Stock Climbs

(RTTNews) - Shares of Precision BioSciences, Inc. (DTIL) were gaining around 11 percent in pre-market activity on the Nasdaq after the clinical-stage gene editing company on Monday announced that the U.S. Food and Drug Administration has cleared the Investigational New Drug or IND application for PBGENE-HBV to eliminate root cause of chronic hepatitis B.

With no curative options currently available for patients, Hepatitis B is a leading cause of morbidity in the US and death globally. PBGENE-HBV is Precision's lead wholly owned in vivo gene editing program under investigation in a global first-in-human clinical trial. It is designed to cure chronic hepatitis B by eliminating cccDNA, the key source of replicating hepatitis B virus or HBV, and inactivating integrated HBV DNA in hepatocytes.

PBGENE-HBV is the first and only potentially curative gene editing program to enter clinical investigation that is specifically designed to eliminate cccDNA and inactivate integrated HBV DNA. Lipid nanoparticle technology for PBGENE-HBV has been provided by Acuitas Therapeutics Inc.

Under the ELIMINATE-B trial, the company is actively enrolling patients in Moldova, Hong Kong, and New Zealand and will soon initiate Phase 1 clinical activities in the U.S at the Liver Center at Massachusetts General Hospital.

Precision noted that it is in final stages of U.S. site activation, enabling the ELIMINATE-B trial to begin enrolling patients in the U.S. where over one million people are infected with chronic hepatitis B.

The Company recently announced promising safety and efficacy data for PBGENE-HBV following first dose administration at the lowest dose level in the ELIMINATE-B clinical trial.

Michael Amoroso, President and Chief Executive Officer of Precision BioSciences, said, "With four regulatory approvals in four months, this clearance validates our parallel global development strategy backed by our robust pre-clinical safety and efficacy package. The ELIMINATE-B trial remains on track following the recent completion of initial dose administration in our first cohort of patients and we look forward to continuing to share clinical data throughout 2025."

Precision said it plans to further expand the study to the U.K. and continue accelerating recruitment and evaluation of a genetically diverse patient population in the Phase 1 study.

In pre-market activity on Nasdaq, Precision BioSciences shares were gaining around 10.52 percent to trade at $5.57.

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