DTIL Gets FDA's Fast Track Tag for Hepatitis B Gene Therapy, Stock Up

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.

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.

Apart from PBGENE-HBV, DTIL’s fully owned pipeline comprises several other gene therapy programs, which are currently undergoing preclinical evaluation. The company’s clinical-stage pipeline comprises a partnered candidate, ECUR-506, which is being developed by iECURE as an in vivo gene editing program in a first-in-human phase I/II OTC-HOPE study for potentially treating neonatal onset ornithine transcarbamylase deficiency.

Precision BioSciences, Inc. Price and Consensus

Precision BioSciences, Inc. price-consensus-chart | Precision BioSciences, Inc. Quote

DTIL Zacks Rank & Stocks to Consider

Precision BioSciences currently carries a Zacks Rank #3 (Hold). 

Some better-ranked stocks from the sector are Bayer BAYRY, Dynavax Technologies Corporation DVAX and ADMA Biologics ADMA, each carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 (Strong Buy) Rank stocks here. 

In the past 30 days, estimates for Bayer’s earnings per share have increased from $1.17 to $1.19 for 2025. During the same time, earnings per share have increased from $1.27 to $1.28 for 2026. Year to date, shares of Bayer have gained 20.5%. 

BAYRY’s earnings matched estimates in two of the trailing three quarters while missing the same on the remaining occasion, the average negative surprise being 19.61%. 

In the past 30 days, estimates for Dynavax’s earnings per share have remained constant at 33 cents for 2025. During the same time, earnings per share have remained constant at 57 cents for 2026. Year to date, shares of DVAX have lost 10.6%. 

DVAX’s earnings beat estimates in three of the trailing four quarters while missing the same on the remaining occasion, the average surprise being 9.58%. 

In the past 30 days, estimates for ADMA Biologics’ 2025 earnings per share have increased from 70 cents to 71 cents. The estimate for 2026 earnings per share has remained constant at 93 cents. Year to date, shares of ADMA Biologics have gained 29.2%. 

ADMA’s earnings beat estimates in three of the trailing four quarters and missed once, delivering an average surprise of 32.8%. 

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