Precision BioSciences Receives U.S. FDA Fast Track Designation for PBGENE-HBV, a First-In-Class Gene Editing Therapy Designed to Eliminate the Root Cause of Chronic Hepatitis B
DURHAM, N.C. --(BUSINESS WIRE)--Apr. 15, 2025-- Precision BioSciences, Inc. (Nasdaq: DTIL), a clinical stage gene editing company utilizing its novel proprietary ARCUS ® platform to develop in vivo gene editing therapies for diseases with high unmet need, today announced that the U.S.
Precision BioSciences to Participate in the 24th Annual Needham Virtual Healthcare Conference
DURHAM, N.C. --(BUSINESS WIRE)--Apr. 1, 2025-- Precision BioSciences, Inc. (Nasdaq: DTIL), a clinical stage gene editing company utilizing its novel proprietary ARCUS ® platform to develop in vivo gene editing therapies, including gene elimination, gene insertion, and gene excision programs, today
Precision BioSciences Reports Fourth Quarter and Fiscal Year 2024 Financial Results and Provides Business Update
- Announced first in vivo clinical validation for ARCUS gene editing across two distinct programs including wholly owned PBGENE-HBV and partnered program ECUR-506 - - Commenced Phase 1 ELIMINATE-B clinical trial for PBGENE-HBV, the first gene editing technology studied for Hepatitis B, in fourth
Precision BioSciences to Report Fourth Quarter and Fiscal Year 2024 Results on March 26, 2025
DURHAM, N.C. --(BUSINESS WIRE)--Mar. 21, 2025-- Precision BioSciences, Inc. (Nasdaq: DTIL), a clinical stage gene editing company utilizing its novel proprietary ARCUS® platform to develop in vivo gene editing therapies, including gene elimination, gene insertion, and gene excision programs, today
Precision BioSciences Presents Preclinical Safety and Efficacy Data Supporting Repeat Dosing of PBGENE-HBV With a Goal of Curing Chronic Hepatitis B at the Global Hepatitis Summit 2025
- PBGENE-HBV, the first and only clinical stage gene editing therapy for chronic hepatitis B – - Repeat dosing of PBGENE-HBV supported by definitive preclinical safety and toxicology studies - - ELIMINATE-B global Phase 1 study for chronic hepatitis B actively enrolling patients and will evaluate
Precision BioSciences Presents Preclinical Efficacy and Durability Data on PBGENE-DMD for the Treatment of Duchenne Muscular Dystrophy (DMD) at the 2025 Muscular Dystrophy Association (MDA) Clinical & Scientific Conference
- Potential first-in-class gene editing approach designed for dystrophin gene correction leading the body to produce a functional dystrophin protein applicable for majority of DMD patients (up to ~60%) - PBGENE-DMD restored dystrophin protein expression and significantly improved muscle function
Precision BioSciences Announces Clearance of Investigational New Drug Application by the U.S. FDA for First-in-Class PBGENE-HBV Designed to Eliminate Root Cause of Chronic Hepatitis B
- PBGENE-HBV is the first-ever investigational in vivo gene editing therapy cleared to enter clinical trials for the treatment of chronic hepatitis B in the United States ( U.S. ) – - IND clearance represents a significant regulatory milestone for PBGENE-HBV – - Company to expand its Phase 1
Precision BioSciences Announces Oral Presentation at the 2025 Muscular Dystrophy Association (MDA) Clinical & Scientific Conference
DURHAM, N.C. --(BUSINESS WIRE)--Feb. 24, 2025-- Precision BioSciences, Inc. (Nasdaq: DTIL), a clinical stage gene editing company utilizing its novel proprietary ARCUS® platform to develop in vivo gene editing therapies, including gene elimination, gene insertion, and gene excision programs, today
Precision BioSciences Announces Initial Safety and Antiviral Activity of PBGENE-HBV in the ELIMINATE-B Clinical Trial
ELIMINATE-B Phase 1 dose finding study for chronic Hepatitis B executing on schedule with completion of first dose administration for cohort 1 (n=3 patients) PBGENE-HBV, the first LNP gene editing technology studied for Hepatitis B, was safe and well tolerated PBGENE-HBV demonstrated substantial
Precision BioSciences Strengthens Senior Leadership Team to Drive Multiple In Vivo Gene Editing Programs
- Cindy Atwell , promoted to Chief Development and Business Officer- - Cassie Gorsuch , PhD, promoted to Chief Scientific Officer – DURHAM, N.C. --(BUSINESS WIRE)--Jan. 29, 2025-- Precision BioSciences, Inc. (Nasdaq: DTIL), a clinical stage gene editing company utilizing its novel proprietary ARCUS
Precision BioSciences Announces Complete Clinical Response in First Infant Dosed by Partner iECURE in Ongoing Phase 1/2 Clinical Trial in Ornithine Transcarbamylase (OTC) Deficiency
- Treatment with ECUR-506 resulted in a complete clinical response from three months post exposure to the end of study (six months post exposure) - ECUR-506 was generally well tolerated with no significant clinical safety concerns - Insertion of a functional OTC gene through ARCUS in vivo gene
Precision BioSciences Receives Approval in Hong Kong to Expand PBGENE-HBV Phase 1 ELIMINATE-B Trial for the Treatment of Chronic Hepatitis B
- Approval in Hong Kong marks the first clinical trial application clearance of an in vivo gene editing approach for chronic hepatitis B in Hong Kong and the second CTA approval for PBGENE-HBV in 2024 - ELIMINATE-B is a global, multi-site study now actively recruiting patients; expected to report
Precision BioSciences to Participate in Upcoming November Investor Conferences
DURHAM, N.C. --(BUSINESS WIRE)--Nov. 21, 2024-- Precision BioSciences, Inc. (Nasdaq: DTIL), a clinical stage gene editing company utilizing its novel proprietary ARCUS® platform to develop in vivo gene editing therapies for sophisticated gene edits, today announced that it will participate in the
Precision BioSciences Highlights Preclinical Data and Outlines Design of First-in-Human Clinical Trial for PBGENE-HBV for Treatment of Chronic Hepatitis B
– PBGENE-HBV preclinical data reinforce safety profile and potential to deliver a functional cure for chronic hepatitis B, supporting advancement into first-in-human clinical study – – Phase 1 dose escalation and expansion trial, ELIMINATE-B, designed to assess safety and efficacy measured by
Precision BioSciences Reports Third Quarter 2024 Financial Results and Provides Business Update
- Received approval for first Clinical Trial Application to advance PBGENE-HBV into first-in-human trials for treatment of chronic hepatitis B; additional global regulatory applications pending approval - Opened PBGENE-HBV phase 1 clinical program in Moldova ; patient screening underway with