FDA fast tracks Precision BioSciences’ hepatitis B treatment

DURHAM, N.C. - Precision BioSciences, Inc. (NASDAQ:DTIL), a gene editing company with a market capitalization of $46.75 million, announced that its lead in vivo gene editing program, PBGENE-HBV, designed to potentially cure chronic hepatitis B, has been granted Fast Track designation by the U.S. Food and Drug Administration (FDA). According to InvestingPro data, the company’s stock has seen significant volatility, with a 49% decline over the past six months despite maintaining a strong balance sheet with more cash than debt. This advancement signifies the agency’s recognition of the program’s potential to address an urgent unmet medical need for patients with chronic hepatitis B.

The Fast Track designation is intended to accelerate the development and review process for treatments targeting serious or life-threatening conditions. PBGENE-HBV, which aims to eliminate cccDNA and inactivate integrated hepatitis B virus (HBV) DNA within liver cells, may benefit from more frequent FDA interactions and a possibility of priority review. With a current ratio of 6.34, the company maintains strong liquidity to support its development programs, though InvestingPro analysis indicates rapid cash utilization.

PBGENE-HBV is currently under evaluation in the global Phase 1 ELIMINATE-B trial, with clinical investigations across the United States, Moldova, Hong Kong, New Zealand, and the United Kingdom. Precision BioSciences anticipates providing updates on the low-dose cohort and data from higher dose levels throughout 2025.

Chronic hepatitis B infection, a major cause of morbidity and mortality worldwide, affects an estimated 300 million people. Current treatments focus on viral suppression but do not eradicate the virus, often necessitating lifelong therapy. PBGENE-HBV’s approach to directly target the genetic basis of the disease could lead to a functional cure, a significant advancement in treatment.

Precision BioSciences’ proprietary ARCUS® platform, which differentiates itself by the precise and targeted way it cuts DNA, is the technology behind PBGENE-HBV. The company’s pipeline includes various in vivo gene editing candidates aimed at providing lasting cures for genetic and infectious diseases with inadequate treatment options.

This announcement is based on a press release statement from Precision BioSciences, Inc. Analysts maintain a bullish outlook on the company, with price targets significantly above current trading levels. InvestingPro analysis suggests the stock is currently trading below its Fair Value, with additional insights available through their comprehensive financial analysis platform. Subscribers can access 8 more exclusive ProTips and detailed metrics to better understand the company’s financial position and growth potential.

In other recent news, Precision BioSciences Inc. has announced several significant developments. The company received FDA clearance for its Investigational New Drug application for PBGENE-HBV, allowing the expansion of its Phase 1 ELIMINATE-B study to the United States. This trial focuses on a gene editing therapy aimed at potentially curing chronic hepatitis B. Precision BioSciences also presented promising preclinical data for its Duchenne muscular dystrophy treatment, PBGENE-DMD, at the Muscular Dystrophy Association Conference, leading H.C. Wainwright to reaffirm a Buy rating and a $60 price target for the company’s stock.

Furthermore, the company released initial findings from the ELIMINATE-B study, showing substantial antiviral activity and a favorable safety profile for PBGENE-HBV. Analysts from H.C. Wainwright expressed optimism about these results, suggesting they could lower perceived risks associated with Precision’s ARCUS gene editing platform. Additionally, the company announced the retirement of Dr. Sam Wadsworth from its Board of Directors, effective January 2025, with no immediate impact on its strategic direction or operations. These recent developments underscore Precision BioSciences’ ongoing progress in gene editing therapies.

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