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Precision BioSciences Receives U.S. Patent Allowances Covering the PBGENE-HBV Program
Businesswire· 2026-03-11 11:01
Core Insights - Precision BioSciences has received two Notices of Allowance from the U.S. Patent and Trademark Office for its PBGENE-HBV program, which focuses on gene editing therapies for Hepatitis B [1] - The first patent application covers engineered meganucleases targeting the Hepatitis B virus genome, while the second application pertains to polypeptide linkers used in these engineered nucleases [1] - The patents, once granted, are expected to provide composition-of-matter protection for the PBGENE-HBV ARCUS nuclease until at least November 2044, enhancing the company's intellectual property portfolio [1] Company Overview - Precision BioSciences is a clinical stage gene editing company utilizing its proprietary ARCUS® platform to develop in vivo gene editing therapies for diseases with high unmet needs [1] - The PBGENE-HBV program is currently in a global first-in-human clinical trial aimed at providing a potentially curative treatment for chronic Hepatitis B infection [1] - The program has received Fast Track designation from the FDA, indicating its potential significance in addressing chronic Hepatitis B [1] Patent Details - The first Notice of Allowance relates to U.S. Patent Application No. 19/347,136, which includes claims for the ARCUS nuclease used in PBGENE-HBV [1] - The second Notice of Allowance pertains to U.S. Patent Application No. 19/273,982, covering any polypeptide that includes a novel, shortened polypeptide linker developed by Precision [1] - Both patents are expected to provide overlapping coverage across multiple patent families, strengthening the company's position in the market [1]
Precision BioSciences to Report Fourth Quarter and Fiscal Year 2025 Results on March 12, 2026
Businesswire· 2026-03-09 20:15
Core Insights - Precision BioSciences, Inc. will report its financial results for the fourth quarter and fiscal year 2025 on March 12, 2026, along with a business update [1] - The company specializes in gene editing therapies using its proprietary ARCUS® platform, aimed at addressing high unmet medical needs [1] Company Overview - Precision BioSciences is a clinical stage gene editing company based in Durham, North Carolina, focusing on in vivo gene editing therapies [1] - The ARCUS® platform is characterized by its unique cutting mechanism, smaller size, and simpler structure, which are designed to achieve more defined therapeutic outcomes [1] - The company's pipeline includes clinical stage candidates targeting genetic and infectious diseases where existing treatments are inadequate [1] Recent Developments - The FDA has granted Fast Track designation to PBGENE-DMD for the treatment of Duchenne muscular dystrophy (DMD) [1] - Precision BioSciences received $7.5 million from TG Therapeutics for achieving a clinical milestone related to the azercabtagene zapreleucel (azer-cel) in multiple sclerosis [1] - New preclinical study data supporting the safety and long-term efficacy of PBGENE-DMD will be presented at the 2026 Muscular Dystrophy Association Clinical & Scientific Conference [1]
Precision BioSciences Receives $7.5M in Proceeds from TG Therapeutics for Azer-cel Clinical Milestone in Multiple Sclerosis
Businesswire· 2026-03-02 12:01
Core Viewpoint - Precision BioSciences, Inc. has achieved a clinical milestone related to its license agreement with TG Therapeutics, Inc. for the development of azercabtagene zapreleucel (azer-cel) in a Phase 1 clinical trial [1] Group 1: Company Achievements - The milestone payment was triggered by the progress of the Phase 1 clinical trial of azer-cel, indicating advancement in the clinical development of this gene editing therapy [1]
Precision BioSciences Announces Presentation at the 2026 Muscular Dystrophy Association Clinical & Scientific Conference
Businesswire· 2026-02-18 12:01
Core Insights - Precision BioSciences announced that new preclinical study data for PBGENE-DMD will be presented at the 2026 Muscular Dystrophy Association Clinical & Scientific Conference, highlighting its potential safety and long-term efficacy [1] Company Overview - Precision BioSciences, Inc. is a clinical-stage gene editing company utilizing its proprietary ARCUS® platform to develop in vivo gene editing therapies for diseases with high unmet needs [1] - The company has received Investigational New Drug clearance from the U.S. FDA for PBGENE-DMD, allowing the initiation of clinical trial site activation [1] Product Details - PBGENE-DMD is a first-in-class gene editing therapy designed to provide durable functional muscle improvement for Duchenne Muscular Dystrophy (DMD) patients with mutations between exons 45 and 55, affecting up to 60% of boys with DMD [1] - The therapy employs a gene excision approach, differentiating it from existing treatments like microdystrophin and exon skipping [1] - Preclinical studies demonstrated significant and durable functional improvements in a humanized DMD mouse model, restoring production of a near full-length functional dystrophin protein across multiple muscle types [1] Clinical Development - The upcoming presentation at the MDA conference will focus on the abstract titled "PBGENE-DMD gene editing treatment leads to safe and long-term functional improvement in humanized DMD-disease mouse model" [1] - The presentation is scheduled for March 9, 2026, and will be a poster presentation [1]
Precision BioSciences Sets Strategic Priorities for 2026 Focused on Continued Advancement of Clinical-Stage Programs PBGENE-HBV for Chronic Hepatitis B and PBGENE-DMD for Duchenne Muscular Dystrophy
Businesswire· 2026-01-12 12:01
Core Viewpoint - Precision BioSciences, Inc. is advancing its gene editing therapies through its proprietary ARCUS® platform, focusing on unmet medical needs and outlining strategic priorities for 2026, with significant progress in its lead programs and a strong financial position to support upcoming milestones [1][2]. Clinical Programs - The PBGENE-HBV program is in a Phase 1/2a ELIMINATE-B trial aimed at curing chronic Hepatitis B by eliminating cccDNA, with positive dose-dependent effects and antiviral activity reported [3][4]. - Safety data from the PBGENE-HBV trial indicated no dose-limiting toxicities at doses up to 0.8 mg/kg, with manageable adverse events observed [4][5]. - Additional dosing cohorts are being explored to optimize the therapeutic index, with 12 participants having completed at least one dose administration [5][6]. - The PBGENE-DMD program is set to begin its Phase 1/2 FUNCTION-DMD trial in late Q1 or early Q2 2026, targeting DMD patients with specific mutations, with initial data expected by the end of 2026 [8][10]. Partnered Programs - ECUR-506, developed by iECURE, is being evaluated for neonatal onset OTC deficiency and has received FDA RMAT designation, with data expected in the first half of 2026 [11]. - The azer-cel CAR T treatment is being developed by Imugene for diffuse large B-cell lymphoma, with Precision receiving an $8 million milestone payment due to progress [12]. - Additional milestone payments are anticipated from TG Therapeutics for azer-cel's ongoing Phase 1 trial in progressive multiple sclerosis [13]. Financial Position - Precision BioSciences expects to report approximately $137 million in cash and equivalents as of December 31, 2025, with a cash runway projected through 2028 to support ongoing clinical programs [14].
Precision BioSciences Announces Presentation of Clinical Data from the ELIMINATE-B Trial at HEP-DART 2025
Businesswire· 2025-11-19 12:01
Core Insights - Precision BioSciences, Inc. is a clinical stage gene editing company focused on developing in vivo gene editing therapies for diseases with high unmet needs [1] Company Announcement - The company announced it will deliver an oral presentation at the Hep-DART 2025 meeting scheduled for December 7–11, 2025, in Honolulu, Hawaii [1] - The presentation will showcase data from the Phase 1 ELIMINATE-B trial of PBGENE-HBV [1]
Precision BioSciences Announces $75 Million Offering of Common Stock, Pre-Funded Warrants and Warrants
Businesswire· 2025-11-10 23:12
Core Viewpoint - Precision BioSciences, Inc. has announced an underwritten offering to sell 10,815,000 shares of its common stock along with warrants to purchase up to 5,407,500 additional shares at a combined price of $6.14 [1] Company Summary - The company is a clinical stage gene editing firm utilizing its proprietary ARCUS® platform to develop in vivo gene editing therapies targeting diseases with high unmet needs [1] - The offering includes both common stock and accompanying warrants, indicating a strategy to raise capital for further development [1]
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
Businesswire· 2025-11-10 22:21
Core Insights - Precision BioSciences, Inc. is a clinical stage gene editing company focused on developing in vivo gene editing therapies for diseases with high unmet needs [1] Group 1 - The company announced a late-breaking oral presentation at the American Association for the Study of Liver Diseases (AASLD) The Liver Meeting® 2025 [1] - The presentation will include data from the ongoing ELIMINATE-B Phase 1 study [1] - The study evaluates PBGENE-HBV, which is described as a first-in-class in vivo gene editing therapy [1]
Precision BioSciences Reports Third Quarter 2025 Financial Results and Provides Business Update
Businesswire· 2025-11-03 12:01
Core Insights - Precision BioSciences, Inc. reported financial results for Q3 2025, highlighting significant advancements in its gene editing pipeline and promising Phase 1 safety and efficacy data for its product PBG [1] Financial Performance - The company announced its financial results for the third quarter ended September 30, 2025, indicating progress in its operations [1] Business Update - Precision BioSciences emphasized strong progress in its gene editing pipeline throughout the third quarter, showcasing the effectiveness of its proprietary ARCUS® platform [1]
Precision BioSciences to Report Third Quarter 2025 Financial Results on November 3, 2025
Businesswire· 2025-10-31 11:01
Core Insights - Precision BioSciences, Inc. is a clinical stage gene editing company focused on developing in vivo gene editing therapies for diseases with high unmet needs [1] - The company will publish its financial results for the third quarter of 2025 and provide a business update on November 3, 2025 [1] Company Overview - Precision BioSciences utilizes its proprietary ARCUS® platform for gene editing [1] - The company is dedicated to improving life through innovative gene editing solutions [1]