Precision BioSciences has received FDA clearance to initiate the phase I ELIMINATE-B study for its gene therapy PBGENE-HBV, aimed at treating chronic hepatitis B.

Precision BioSciences anticipates providing updates on the ELIMINATE-B study throughout 2025, including results from both low and higher dose cohorts.

As of April 2025, Precision BioSciences holds a Zacks Rank of #3 (Hold), while competitors like Bayer and Dynavax have higher rankings, indicating varying levels of market confidence.

Currently, patients are being enrolled in the low-dose cohort of the ELIMINATE-B study, with plans to escalate to higher doses to determine the optimal treatment parameters.

Following the FDA's Fast Track designation for PBGENE-HBV, Precision BioSciences' stock surged by 23.8% on April 15, 2025, reflecting increased investor confidence.

The Fast Track designation expedites the development and review process for promising treatments, allowing for benefits such as rolling submissions and increased interactions with the FDA.

The study, which began in April 2025, includes locations in the United States and the United Kingdom to ensure a diverse patient recruitment.

Notably, PBGENE-HBV is the first gene editing program of its kind to enter clinical trials as a potential cure for hepatitis B, a disease affecting approximately 300 million people worldwide.

Current antiviral therapies for hepatitis B only suppress the virus, necessitating lifelong treatment, which underscores the need for PBGENE-HBV's innovative approach to potentially provide a functional cure.

PBGENE-HBV is designed to eliminate cccDNA, the main source of the replicating virus, and inactivate integrated HBV DNA in liver cells.

In addition to PBGENE-HBV, the company is developing several other gene therapy programs, including a partnered candidate for treating a metabolic disorder.

Despite existing antiviral treatments, the significant health challenge posed by hepatitis B remains, as it can lead to severe complications without a functional cure.