DTIL Precision BioSciences

Precision BioSciences to Present PBGENE-HBV Data at AASLD The Liver Meeting 2026

Precision BioSciences will present data on its PBGENE-HBV program at The Liver Meeting 2026. The presentation will focus on durable pgRNA loss in patients treated with PBGENE-HBV, supporting its potential path towards a viral cure for chronic hepatitis B. The presentation is scheduled for Sunday, November 8, 2026.

Precision BioSciences Reports PBGENE-HBV Phase 1 Biopsy Data at EASL 2026

ELIMINATE-B trial showed first clinical biopsy evidence of direct cccDNA elimination with 1-log reduction and <1% remaining after two doses; pgRNA became durably undetectable in 100% of evaluable patients with ongoing loss up to six months.

Precision BioSciences: PBGENE-HBV late-breaking poster at EASL 2026

A late-breaking poster titled 'First evidence of elimination and inactivation of cccDNA in liver biopsies collected from patients with chronic hepatitis B treated with PBGENE-HBV' was accepted for presentation at the EASL Congress 2026. The poster will be presented during the Late-Breaker poster session on May 27-30, 2026 in Barcelona, Spain.

Precision BioSciences expands ELIMINATE-B trial to France and Romania

CTA approvals in France and Romania allow new clinical sites to be added to the ongoing global ELIMINATE-B trial of PBGENE-HBV. Site initiation is underway and first patient screening is expected in Q2 2026, expanding the trial footprint beyond existing sites in the UK, Moldova, New Zealand, Hong Kong and the US.

Precision BioSciences: PBGENE-DMD IND cleared, FUNCTION-DMD site activation underway

The 8-K exhibit announces FDA IND clearance for PBGENE-DMD and that site activation for the FUNCTION-DMD Phase 1/2 trial is now underway. The company expects initial clinical data across multiple patients in late-2026, with target enrollment of 3-5 patients and early efficacy assessed by near full-length dystrophin expression at 12 weeks.

Precision BioSciences receives FDA Fast Track for PBGENE-DMD

FDA granted Fast Track designation to PBGENE-DMD on February 26, 2026, providing eligibility for more frequent FDA interactions and rolling review. The designation follows IND clearance and Orphan Drug status, accelerating the regulatory path for the Phase 1/2 FUNCTION-DMD trial.

Precision BioSciences receives FDA Study May Proceed for PBGENE-DMD

FDA cleared the IND for PBGENE-DMD, allowing the company to begin IRB review and site activation for the Phase 1/2 FUNCTION-DMD trial. The program is the first in vivo gene-editing therapy designed to correct the dystrophin gene in the exons 45-55 hotspot, covering ~60% of DMD patients. The company expects to activate the first U.S. clinical site in H1 2026 and plans a KOL virtual event in March.

Precision BioSciences 2026 priorities: PBGENE-HBV data at conferences; PBGENE-DMD IND Q1

Company announced 2026 clinical milestones for PBGENE-HBV (additional biopsy data H1 2026, conference updates) and PBGENE-DMD (IND clearance Q1 2026, first patient dosing late-Q1/early-Q2 2026, initial data by year-end 2026). Cash runway extended through 2028 to fund these milestones.