Precision BioSciences Advances PBGENE-HBV and PBGENE-DMD Trials, Data Updates Expected in 2026
- Clinical Trial Progress: Precision BioSciences' PBGENE-HBV is currently undergoing the Phase 1/2a ELIMINATE-B trial, which has shown dose-dependent antiviral activity, with data updates expected at medical conferences in 2026, potentially offering a cure for chronic hepatitis B patients.
- Strong Financial Position: As of December 31, 2025, Precision anticipates having approximately $137 million in cash and cash equivalents, which is expected to fund key data milestones for PBGENE-HBV and PBGENE-DMD, ensuring operational stability through 2028.
- New DMD Treatment Approach: The PBGENE-DMD Phase 1/2 FUNCTION-DMD trial is expected to receive IND clearance in Q1 2026, aiming to provide durable functional muscle improvement for 60% of DMD patients, with initial data anticipated by the end of 2026.
- Collaborative Project Advancements: The ECUR-506 project with iECURE has reached key alignment with the FDA, supporting its potential as a curative treatment for neonatal OTC deficiency, with clinical trial data expected to be released in the first half of 2026, further enhancing Precision's market position.
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Precision BioSciences Advances PBGENE-HBV and PBGENE-DMD Trials, Data Updates Expected in 2026
- Clinical Trial Progress: Precision BioSciences' PBGENE-HBV is currently undergoing the Phase 1/2a ELIMINATE-B trial, which has shown dose-dependent antiviral activity, with data updates expected at medical conferences in 2026, potentially offering a cure for chronic hepatitis B patients.
- Strong Financial Position: As of December 31, 2025, Precision anticipates having approximately $137 million in cash and cash equivalents, which is expected to fund key data milestones for PBGENE-HBV and PBGENE-DMD, ensuring operational stability through 2028.
- New DMD Treatment Approach: The PBGENE-DMD Phase 1/2 FUNCTION-DMD trial is expected to receive IND clearance in Q1 2026, aiming to provide durable functional muscle improvement for 60% of DMD patients, with initial data anticipated by the end of 2026.
- Collaborative Project Advancements: The ECUR-506 project with iECURE has reached key alignment with the FDA, supporting its potential as a curative treatment for neonatal OTC deficiency, with clinical trial data expected to be released in the first half of 2026, further enhancing Precision's market position.
iECURE Secures FDA RMAT Designation for ECUR-506, Advancing OTC Deficiency Treatment
- Regulatory Milestone: iECURE's ECUR-506 has received FDA's Regenerative Medicine Advanced Therapy (RMAT) designation, which will provide accelerated review and intensive guidance for its development in treating neonatal onset ornithine transcarbamylase deficiency, thereby expediting the clinical development process.
- Clinical Study Alignment: The company has aligned with the FDA on primary and secondary efficacy endpoints, comparators, and sample size for the ongoing OTC-HOPE study, laying the groundwork for a future Biologics License Application (BLA) and showcasing its potential in the rare disease space.
- Innovation Passport: ECUR-506 has also been awarded an Innovation Passport under the UK's Innovative Licensing and Access Pathway (ILAP), making it one of only three selected investigational medicinal products, underscoring its potential to address significant unmet medical needs.
- Clinical Data Support: Encouraging clinical data from the OTC-HOPE study, including a complete clinical response observed in the first treated infant, further validates the efficacy of ECUR-506 and may inform the development of other indications in the pipeline.
Biotech Stocks Surge in After-Hours Trading with Gains from BioAtla, Entero, and Sonnet
BioAtla Inc. Gains: BioAtla's shares surged 13.94% in after-hours trading, attributed to investor reactions to recent financing agreements, despite no new company-specific news.
Metagenomi Inc. and PAVmed Inc. Movements: Metagenomi's stock rose 5.71% with no new updates, while PAVmed advanced 5.72% after reporting a significant net loss and a sharp decline in revenue.
Precision BioSciences' Positive Outlook: Precision BioSciences gained 2.94% after announcing it will present Phase 1 trial data at an upcoming conference, boosting investor optimism.
Entero Therapeutics Rebranding: Entero Therapeutics' shares increased 3.68% following its announcement of a rebranding to GridAI Technologies Corp., effective December 1, 2025, along with a new ticker symbol.
Precision BioSciences Initiates $75 Million Stock and Warrant Sale
Stock Offering Announcement: Precision BioSciences announced an underwritten offering of approximately 10.8 million shares of common stock, along with warrants for an additional 5.4 million shares, priced at $6.14 per share.
Pre-Funded Warrants Details: Certain investors will receive pre-funded warrants for up to 1.4 million shares and half-warrants for 700,000 more shares, priced slightly lower at $6.139995 per unit.
Expected Proceeds: The gross proceeds from the offering are anticipated to be around $75 million before deducting underwriting discounts and expenses.
Additional Information: The announcement is part of Precision BioSciences' ongoing financial activities, including presentations at investment conferences and historical earnings data.
Precision BioSciences Unveils $75 Million Common Stock, Pre-Funded Warrants, and Warrant Offering
Offering Details: Precision BioSciences announced an underwritten offering of 10,815,000 shares of common stock and warrants, aiming to raise approximately $75 million for research and development and general corporate purposes.
Investor Participation: The offering includes participation from both new and existing investors, such as Aberdeen Investments and Driehaus Capital Management, and is expected to close around November 12, 2025.
ARCUS® Platform: Precision BioSciences utilizes its proprietary ARCUS® gene editing platform to develop therapies for diseases with high unmet needs, focusing on delivering lasting cures for genetic and infectious diseases.
Forward-Looking Statements: The announcement includes forward-looking statements regarding the offering's timing and proceeds, highlighting potential risks and uncertainties that could affect actual results.
Precision BioSciences Unveils New Phase 1 PBGENE-HBV Findings at AASLD The Liver Meeting®, Highlighting Safety, Tolerability, and Dose-Dependent Antiviral Effects in Initial Three Cohorts
PBGENE-HBV Overview: PBGENE-HBV is the first gene editing therapy targeting chronic Hepatitis B by eliminating HBV cccDNA and inactivating integrated HBV DNA, with promising results presented at the AASLD meeting on November 10, 2025.
Clinical Trial Results: The Phase 1 ELIMINATE-B study showed that PBGENE-HBV was well-tolerated across multiple doses, with all patients experiencing significant reductions in hepatitis B surface antigen (HBsAg) and evidence of antiviral activity.
Biopsy Evidence: Paired liver biopsy data confirmed direct gene editing of HBV DNA in patients, marking a significant milestone in demonstrating the therapy's mechanism and potential for a functional cure.
Future Directions: Precision BioSciences plans to complete dosing in the current cohort and expand the study to evaluate optimized dosing regimens, aiming to establish a path toward stopping nucleos(t)ide analogs and testing for a cure.
Precision BioSciences Advances PBGENE-HBV and PBGENE-DMD Trials, Data Updates Expected in 2026
- Clinical Trial Progress: Precision BioSciences' PBGENE-HBV is currently undergoing the Phase 1/2a ELIMINATE-B trial, which has shown dose-dependent antiviral activity, with data updates expected at medical conferences in 2026, potentially offering a cure for chronic hepatitis B patients.
- Strong Financial Position: As of December 31, 2025, Precision anticipates having approximately $137 million in cash and cash equivalents, which is expected to fund key data milestones for PBGENE-HBV and PBGENE-DMD, ensuring operational stability through 2028.
- New DMD Treatment Approach: The PBGENE-DMD Phase 1/2 FUNCTION-DMD trial is expected to receive IND clearance in Q1 2026, aiming to provide durable functional muscle improvement for 60% of DMD patients, with initial data anticipated by the end of 2026.
- Collaborative Project Advancements: The ECUR-506 project with iECURE has reached key alignment with the FDA, supporting its potential as a curative treatment for neonatal OTC deficiency, with clinical trial data expected to be released in the first half of 2026, further enhancing Precision's market position.
iECURE Secures FDA RMAT Designation for ECUR-506, Advancing OTC Deficiency Treatment
- Regulatory Milestone: iECURE's ECUR-506 has received FDA's Regenerative Medicine Advanced Therapy (RMAT) designation, which will provide accelerated review and intensive guidance for its development in treating neonatal onset ornithine transcarbamylase deficiency, thereby expediting the clinical development process.
- Clinical Study Alignment: The company has aligned with the FDA on primary and secondary efficacy endpoints, comparators, and sample size for the ongoing OTC-HOPE study, laying the groundwork for a future Biologics License Application (BLA) and showcasing its potential in the rare disease space.
- Innovation Passport: ECUR-506 has also been awarded an Innovation Passport under the UK's Innovative Licensing and Access Pathway (ILAP), making it one of only three selected investigational medicinal products, underscoring its potential to address significant unmet medical needs.
- Clinical Data Support: Encouraging clinical data from the OTC-HOPE study, including a complete clinical response observed in the first treated infant, further validates the efficacy of ECUR-506 and may inform the development of other indications in the pipeline.
Biotech Stocks Surge in After-Hours Trading with Gains from BioAtla, Entero, and Sonnet
BioAtla Inc. Gains: BioAtla's shares surged 13.94% in after-hours trading, attributed to investor reactions to recent financing agreements, despite no new company-specific news.
Metagenomi Inc. and PAVmed Inc. Movements: Metagenomi's stock rose 5.71% with no new updates, while PAVmed advanced 5.72% after reporting a significant net loss and a sharp decline in revenue.
Precision BioSciences' Positive Outlook: Precision BioSciences gained 2.94% after announcing it will present Phase 1 trial data at an upcoming conference, boosting investor optimism.
Entero Therapeutics Rebranding: Entero Therapeutics' shares increased 3.68% following its announcement of a rebranding to GridAI Technologies Corp., effective December 1, 2025, along with a new ticker symbol.
Precision BioSciences Initiates $75 Million Stock and Warrant Sale
Stock Offering Announcement: Precision BioSciences announced an underwritten offering of approximately 10.8 million shares of common stock, along with warrants for an additional 5.4 million shares, priced at $6.14 per share.
Pre-Funded Warrants Details: Certain investors will receive pre-funded warrants for up to 1.4 million shares and half-warrants for 700,000 more shares, priced slightly lower at $6.139995 per unit.
Expected Proceeds: The gross proceeds from the offering are anticipated to be around $75 million before deducting underwriting discounts and expenses.
Additional Information: The announcement is part of Precision BioSciences' ongoing financial activities, including presentations at investment conferences and historical earnings data.
Precision BioSciences Unveils $75 Million Common Stock, Pre-Funded Warrants, and Warrant Offering
Offering Details: Precision BioSciences announced an underwritten offering of 10,815,000 shares of common stock and warrants, aiming to raise approximately $75 million for research and development and general corporate purposes.
Investor Participation: The offering includes participation from both new and existing investors, such as Aberdeen Investments and Driehaus Capital Management, and is expected to close around November 12, 2025.
ARCUS® Platform: Precision BioSciences utilizes its proprietary ARCUS® gene editing platform to develop therapies for diseases with high unmet needs, focusing on delivering lasting cures for genetic and infectious diseases.
Forward-Looking Statements: The announcement includes forward-looking statements regarding the offering's timing and proceeds, highlighting potential risks and uncertainties that could affect actual results.
Precision BioSciences Unveils New Phase 1 PBGENE-HBV Findings at AASLD The Liver Meeting®, Highlighting Safety, Tolerability, and Dose-Dependent Antiviral Effects in Initial Three Cohorts
PBGENE-HBV Overview: PBGENE-HBV is the first gene editing therapy targeting chronic Hepatitis B by eliminating HBV cccDNA and inactivating integrated HBV DNA, with promising results presented at the AASLD meeting on November 10, 2025.
Clinical Trial Results: The Phase 1 ELIMINATE-B study showed that PBGENE-HBV was well-tolerated across multiple doses, with all patients experiencing significant reductions in hepatitis B surface antigen (HBsAg) and evidence of antiviral activity.
Biopsy Evidence: Paired liver biopsy data confirmed direct gene editing of HBV DNA in patients, marking a significant milestone in demonstrating the therapy's mechanism and potential for a functional cure.
Future Directions: Precision BioSciences plans to complete dosing in the current cohort and expand the study to evaluate optimized dosing regimens, aiming to establish a path toward stopping nucleos(t)ide analogs and testing for a cure.
