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Shares of Precision BioSciences DTIL rallied 23.8% on Tuesday after the company’s announcement that the FDA has granted Fast Track designation to PBGENE-HBV. This is DTIL’s lead, fully owned in vivo gene editing program aimed at curing chronic hepatitis B by eliminating cccDNA — the primary source of replicating hepatitis B virus (HBV) — and inactivating integrated HBV DNA in liver cells (hepatocytes).
The FDA’s Fast Track designation is intended to speed up the development and review of drugs that treat serious conditions and fulfill unmet medical needs. It offers benefits, such as more frequent FDA interactions, rolling submission of marketing applications, and potential eligibility for Priority Review if certain conditions are met.
According to Precision BioSciences, PBGENE-HBV is the first and only gene editing program with this unique mechanism of action to enter the clinical stage as a potential cure.
Year to date, shares of DTIL have surged 44.9% against the industry’s 6.4% decline.
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More on DTIL’s Hepatitis B Gene Therapy Program
Last month, Precision BioSciences received FDA clearance to begin the phase I ELIMINATE-B study of PBGENE-HBV for chronic hepatitis B in the United States. The study is simultaneously being conducted across several other geographies, including the United Kingdom, to accelerate the recruitment and evaluation of a genetically diverse patient population in the ongoing early-stage study.
The company is currently enrolling and dosing patients in the low-dose (0.2 mg/kg) Cohort 1 of the ELIMINATE-B study. Precision BioSciences also plans to escalate to a higher dose level in Cohort 2, aiming to determine the optimal dosage and number of administrations needed to safely eliminate cccDNA and inactivate integrated HBV DNA. DTIL expects to provide updates throughout 2025 on the complete low-dose cohort, including multiple dose administrations, as well as data from higher dose levels.
Per management, hepatitis B remains a major health challenge, with around 300 million people worldwide and up to two million in the United States living with chronic infection. Despite existing antiviral therapies, there is no cure, and many patients face risks of serious complications like cirrhosis, liver failure, or liver cancer.
Current treatments have been unsuccessful in eliminating the driving factors of chronic HBV, resulting in only viral suppression and requiring lifelong use without achieving a functional cure. Precision BioSciences looks to address this unmet medical need with its PBGENE-HBV gene therapy.