Drugs / PBGENE-HBV
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | Other | — | chronic hepatitis B virus infection | 2024-09-30 | “The CTA submissions for PBGENE-HBV are important milestones for Precision as we pioneer this potentially curative therapy for chronic hepatitis B.” precisionbiosciences.com ↗ “today announced that the Company submitted Clinical Trial Applications (CTA) to initiate a Phase 1 study evaluating PBGENE-HBV.” precisionbiosciences.com ↗ |
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1 | NCT06680232 | Nov 2024 → Dec 2025 overdue | chronic hepatitis B virus infection | Precision BioSciences, Inc. | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 24
| Date | Issuer | Release |
|---|---|---|
| 2026-05-27 | Precision BioSciences, Inc. | Results Precision BioSciences Announces New and Late-Breaking PBGENE-HBV Clinical Data from the ELIMINATE-B Study at European Association for the Study of the Liver Congress 2026 precisionbiosciences.com ↗
New biopsy data demonstrate that PBGENE-HBV directly eliminated cccDNA through its primary mechanism leading to a 1-log (10-fold) reduction in cccDNA-derived transcripts |
| 2026-04-15 | Precision BioSciences, Inc. | Regulatory Precision BioSciences Expands ELIMINATE-B Trial Following Clinical Trial Application Approval in Two European Countries precisionbiosciences.com ↗
today announced that it has received Clinical Trial Application (CTA) approval to expand the ongoing global ELIMINATE-B clinical trial of PBGENE-HBV. |
| 2025-11-10 | Precision BioSciences, Inc. | Results Precision BioSciences Presents Late-Breaking Phase 1 PBGENE-HBV Data at AASLD The Liver Meeting® Showing Safety, Tolerability and Cumulative, Dose-Dependent Antiviral Activity in First Three Cohorts precisionbiosciences.com ↗
Data to date from the Phase 1 ELIMINATE-B study demonstrates dose-dependent antiviral response, with activity observed in all nine patients across 22 doses in first three study cohorts |
| 2025-09-12 | Precision BioSciences, Inc. | Results Precision BioSciences Presents Data from the Phase 1 ELIMINATE-B Trial of PBGENE-HBV at the 6th International Coalition to Eliminate HBV Cure Symposium precisionbiosciences.com ↗
In the ELIMINATE-B trial following multiple administrations across two dose levels (Cohort 1 and Cohort 2), PBGENE-HBV has been well-tolerated and active. |
| 2025-08-07 | Precision BioSciences, Inc. | Results Precision BioSciences Reports Second Quarter 2025 Financial Results and Provides Business Update precisionbiosciences.com ↗
PBGENE-HBV demonstrated substantial antiviral activity in all Cohort 1 patients, with best responses achieving a 47-69% reduction in Hepatitis B surface antigen (HBsAg) and durable HBsAg reduction in one patient 7 months after initial dose administration |
| 2025-08-06 | Precision BioSciences, Inc. | Results Precision BioSciences Announces Phase 1 Safety and Efficacy for Cohort 1, Lowest Dose Level in ELIMINATE-B, a First-In-Human Trial of PBGENE-HBV for Chronic Hepatitis B precisionbiosciences.com ↗
PBGENE-HBV demonstrated substantial antiviral activity in all three patients in Cohort 1, with best responses achieving a 47-69% Hepatitis B surface antigen (HBsAg) reduction |
| 2025-05-07 | Precision BioSciences, Inc. | Results Precision BioSciences Announces Presentation of Initial Safety Data from the Phase 1 ELIMINATE-B Trial Evaluating PBGENE-HBV at the 2025 European Association for the Study of the Liver Congress (EASL) precisionbiosciences.com ↗
PBGENE-HBV was well-tolerated upon repeat dosing, with no dose limiting toxicities, serious adverse events, or clinically significant laboratory abnormalities. |
| 2025-04-15 | Precision BioSciences, Inc. | Regulatory 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 precisionbiosciences.com ↗ |
| 2025-03-26 | Precision BioSciences, Inc. | Results Precision BioSciences Reports Fourth Quarter and Fiscal Year 2024 Financial Results and Provides Business Update precisionbiosciences.com ↗
PBGENE-HBV was well-tolerated and none of the patients experienced a Grade ≥2 treatment-related adverse event or serious adverse event. |
| 2025-03-20 | Precision BioSciences, Inc. | Results 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 precisionbiosciences.com ↗
These new data highlight the potential to safely administer repeated doses of PBGENE-HBV, a LNP delivered gene editor, to achieve durable functional cures in chronic hepatitis B patients, |
| 2025-03-17 | Precision BioSciences, Inc. | Regulatory 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 precisionbiosciences.com ↗
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 high unmet need diseases, today announced that the U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) application for PBGENE-HBV. |
| 2025-02-19 | Precision BioSciences, Inc. | Results Precision BioSciences Announces Initial Safety and Antiviral Activity of PBGENE-HBV in the ELIMINATE-B Clinical Trial precisionbiosciences.com ↗
PBGENE-HBV, which comprises an ARCUS-encoding mRNA encapsulated in a lipid nanoparticle (LNP), was safe and well tolerated in all three participants in cohort 1 after the first administration of a 0.2 mg/kg dose. |
| 2024-12-18 | Precision BioSciences, Inc. | Regulatory Precision BioSciences Receives Approval in Hong Kong to Expand PBGENE-HBV Phase 1 ELIMINATE-B Trial for the Treatment of Chronic Hepatitis B precisionbiosciences.com ↗
today announced that it has received Clinical Trial Application (CTA) approval in Hong Kong to study PBGENE-HBV in the ongoing ELIMINATE-B Phase I trial. |
| 2024-11-15 | Precision BioSciences, Inc. | Results Precision BioSciences Highlights Preclinical Data and Outlines Design of First-in-Human Clinical Trial for PBGENE-HBV for Treatment of Chronic Hepatitis B precisionbiosciences.com ↗
Observed sustained declines in key viral biomarkers, HBV DNA and hepatitis B surface antigen (HBsAg), indicative of a functional cure in transgenic mouse models following administration of PBGENE-HBV and nucleoside analogue withdrawal. |
| 2024-10-28 | Precision BioSciences, Inc. | Regulatory Precision BioSciences to Host Virtual Investor Event Highlighting PBGENE-HBV Preclinical Safety Data and Phase 1 Clinical Trial Plans on November 15, 2024 precisionbiosciences.com ↗
In addition, members of Precision BioSciences’ executive management team will highlight final PBGENE-HBV preclinical safety data and phase 1 clinical trial plans now that Precision has received Clinical Trial Application approval in Moldova with other global regulatory approvals pending. |
| 2024-10-24 | Precision BioSciences, Inc. | Regulatory Precision BioSciences Receives First Approval of Clinical Trial Application to Initiate PBGENE-HBV First-In-Human Study for the Treatment of Chronic Hepatitis B precisionbiosciences.com ↗
today announced that it has received Clinical Trial Application (CTA) approval in Moldova for its lead candidate, PBGENE-HBV. |
| 2024-09-30 | Precision BioSciences, Inc. | Regulatory Precision BioSciences Submits First Clinical Trial Applications to Initiate Phase 1 Trial for PBGENE-HBV for the Treatment of Chronic Hepatitis B precisionbiosciences.com ↗
The CTA submissions for PBGENE-HBV are important milestones for Precision as we pioneer this potentially curative therapy for chronic hepatitis B. |
| 2024-06-05 | Precision BioSciences, Inc. | Results Precision BioSciences Presents New Preclinical Safety Data for PBGENE-HBV Clinical Candidate at the European Association for the Study of the Liver Congress precisionbiosciences.com ↗
The poster presentation highlights data in primary human hepatocytes demonstrating the high specificity and lack of detectable off-target editing for PBGENE-HBV at therapeutically relevant doses. |
| 2024-02-14 | Precision BioSciences, Inc. | Regulatory Precision BioSciences Receives Pre-IND Feedback from US FDA for PBGENE-HBV as it Advances Towards Clinical Readiness precisionbiosciences.com ↗
today announced that the company has received pre-IND regulatory feedback from the U.S. Food and Drug Administration (FDA) and ex- U.S. agencies. |
| 2023-11-13 | Precision BioSciences, Inc. | Results Precision BioSciences Presents Late-Breaking Data Highlighting Preclinical Efficacy and Safety of PBGENE-HBV for Chronic Hepatitis B at AASLD’s The Liver Meeting 2023 precisionbiosciences.com ↗
In multiple HBV disease models, PBGENE-HBV demonstrated ability to inhibit viral markers and eliminate cccDNA in HBV-infected primary human liver cells. |
| 2023-06-22 | Precision BioSciences, Inc. | Results Precision BioSciences Announces Oral Presentation of Positive ARCUS® Gene Editing Data at International Liver Congress 2023 precisionbiosciences.com ↗
High antiviral activity with substantial and durable reductions in hepatitis B serum antigen and covalently closed circular DNA in preclinical studies of PBGENE-HBV |
| 2022-05-18 | Precision BioSciences, Inc. | Results Precision BioSciences Announces Publication in Molecular Therapy of ARCUS® In Vivo Gene Editing as a Promising Therapeutic Approach to Cure Chronic Hepatitis B Infection precisionbiosciences.com ↗
ARCUS Genome Editing Achieved Substantial Reductions in both cccDNA and Hepatitis B Surface Antigen (HBsAg), 85% and 77% respectively, in HBV-infected Primary Human Hepatocytes (PHH) |
| 2022-05-16 | Precision BioSciences, Inc. | Results Precision BioSciences Announces Preclinical Data Showcasing Premier In Vivo Gene Editing Capabilities at American Society of Gene & Cell Therapy Annual Meeting precisionbiosciences.com ↗
ARCUS efficiently targeted and degraded HBV covalently closed circular (cccDNA) by 85% and reduced expression of Hepatitis B Surface Antigen (HBsAg) by 77% in HBV-infected primary human hepatocytes (PHH). |
| 2021-12-03 | Precision BioSciences, Inc. | Results Precision BioSciences to Present Preclinical Gene Editing Data on its ARCUS-Based Chronic Hepatitis B Program at the HEP DART 2021 Conference precisionbiosciences.com ↗
At HEP DART 2021, we are pleased to share preclinical research illustrating how our ARCUS gene editing technology edited and degraded the covalently closed circular DNA, or cccDNA, responsible for HBV replication and virus persistence. |
All press releases naming this drug 32 releases
Evidence & citations 2 cited values
Every value below carries the sentence it was read from. 1 source stands behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | PBGENE-HBV | ClinicalTrials.gov intervention name — accepted as the source's own label NCT06680232 ↗ |
| Route | Intravenous | “multiple IV dose administrations of PBGENE-HBV” NCT06680232 ↗ |