Precision BioSciences Inc (NASDAQ:DTIL) saw its shares climb 12.8% in premarket trading on Wednesday after disclosing clinical biopsy data from the ELIMINATE-B study at the European Association for the Study of the Liver Annual Congress 2026.
The Durham, North Carolina-based gene editing company reported that analyses of liver biopsies demonstrated PBGENE-HBV directly reduced cccDNA activity. Specifically, long-read transcript sequencing detected a 1-log, or 10-fold, reduction in transcripts derived from covalently closed circular DNA (cccDNA). The company described this finding as the first clinical evidence that a therapeutic agent can eliminate and inactivate cccDNA in liver biopsy samples from patients with chronic hepatitis B.
Study investigators established pregenomic RNA (pgRNA) as a biomarker that reflects cccDNA elimination by PBGENE-HBV. According to the reported data, PBGENE-HBV achieved pgRNA loss in 100% of patients who had detectable pgRNA at baseline, indicating consistent biomarker response among that subgroup.
At the May 4, 2026 data cutoff, the trial had administered 38 doses to 16 patients distributed across five cohorts. The liver biopsy work used long-read transcript sequencing to quantify changes in cccDNA-derived transcripts. The company reported that reductions were observed after only two administrations at the 0.4 mg/kg dose. Following three administrations, editing activity reached 80% of the remaining cccDNA.
In addition to transcript and biomarker changes, Precision BioSciences reported antigen responses. All 15 patients for whom HBsAg data were cited experienced substantial declines in HBsAg, with the duration of response among patients receiving repeat administrations ranging from 1.5 months to more than 12 months.
On safety, the company reported no dose-limiting toxicities. The most frequently observed adverse events were infusion-related reactions consistent with lipid nanoparticle effects; these reactions had onset and resolution within 24 hours. The company also reported transient, Grade 3 or higher reversible ALT/AST laboratory abnormalities. Those laboratory changes were described as asymptomatic and occurred without accompanying elevations in bilirubin.
Precision BioSciences indicated it expects to provide additional updates on the ELIMINATE-B trial by the end of 2026.
Key points
- Clinical biopsy data show a 1-log reduction in cccDNA-derived transcripts following PBGENE-HBV dosing, with evidence of cccDNA inactivation in liver biopsies.
- PBGENE-HBV achieved pgRNA loss in 100% of patients with detectable pgRNA at baseline; HBsAg declines were observed across 15 patients with responses lasting 1.5 to 12+ months.
- The report has market implications for biotech and healthcare sectors, reflected by a 12.8% premarket share increase for DTIL.
Risks and uncertainties
- The ELIMINATE-B dataset is limited in size as of the May 4, 2026 cutoff - 16 patients received 38 doses across five cohorts - which may limit the generalizability of the findings.
- Transient Grade 3 or higher reversible ALT/AST lab abnormalities were observed; although asymptomatic and without elevated bilirubin, these laboratory signals remain a safety consideration for clinical development.
- Future trial readouts are pending - the company expects additional updates by the end of 2026 - and subsequent data could affect clinical and market interpretation.
This report focuses on the presented ELIMINATE-B clinical and biopsy results and the immediate market reaction. It reflects the data disclosed through the May 4, 2026 cutoff and the company statements regarding safety and planned updates.