Welcome to our dedicated page for Precision Biosciences news (Ticker: DTIL), a resource for investors and traders seeking the latest updates and insights on Precision Biosciences stock.
News and updates for Precision BioSciences, Inc. (Nasdaq: DTIL) center on its progress as a clinical stage gene editing company using the ARCUS platform to develop in vivo therapies for serious genetic and infectious diseases. Company announcements frequently highlight developments in its pipeline, clinical trial milestones, scientific publications, and capital markets activity.
A major focus of Precision’s news flow is PBGENE-HBV, the company’s wholly owned in vivo gene editing program for chronic hepatitis B. Updates include data from the global ELIMINATE-B trial, covering safety, dose-dependent antiviral activity, reductions in hepatitis B surface antigen (HBsAg), and biopsy evidence of ARCUS-mediated viral DNA editing. Press releases also describe regulatory designations such as Breakthrough Therapy status and the expansion of clinical trial sites across multiple countries.
Another recurring theme is PBGENE-DMD, a muscle-targeted excision program for Duchenne muscular dystrophy. News items discuss preclinical data on dystrophin restoration and functional muscle improvement, preparations for investigational new drug (IND) submissions, and plans for Phase 1/2 clinical studies in DMD patients with mutations in exons 45–55 of the dystrophin gene.
Investors can also find updates on partnered in vivo programs, such as ECUR-506 for neonatal onset OTC deficiency developed by iECURE using a licensed ARCUS nuclease, along with regulatory milestones like RMAT designation. Additional coverage includes progress in non-core ex vivo programs such as azer-cel, an allogeneic CAR T therapy being advanced by partners for lymphoma and autoimmune diseases.
Financial and corporate news, including quarterly results, equity offerings, and strategic priorities, round out the DTIL news stream. For those tracking gene editing, hepatitis B, DMD, and ARCUS-based therapies, this page provides an organized view of Precision BioSciences’ latest disclosures and clinical developments over time.
Precision BioSciences (NASDAQ: DTIL) announced key leadership changes to strengthen its in vivo gene editing programs. Cindy Atwell has been promoted to Chief Development and Business Officer, overseeing development functions including clinical, regulatory, and business development. She will supervise the PBGENE-HBV program and future in vivo initiatives.
Dr. Cassie Gorsuch has been elevated to Chief Scientific Officer, leading non-clinical development and gene therapy discovery. She will manage preclinical proof of concept and IND-enabling data for clinical studies advancement. The company's PBGENE-HBV program remains on schedule with Phase 1 clinical data expected in 2025.
Additionally, Dr. Sam Wadsworth has retired from his Director role on the company's Board.
Precision BioSciences (DTIL) announced positive clinical data from its partner iECURE's Phase 1/2 OTC-HOPE study. The first infant treated with ECUR-506, which uses Precision's ARCUS® nuclease technology, achieved a complete clinical response that was maintained from three to six months post-treatment.
The treatment was generally well-tolerated, with only asymptomatic transaminitis occurring at four weeks, which resolved within four weeks using immunosuppressive therapy. After twelve weeks, the patient no longer required ammonia scavenger medication and could increase protein intake to age-appropriate levels, with ammonia levels remaining normal.
iECURE expects to complete enrollment in 2025 and provide complete data in first half of 2026. The study is being conducted across the UK, US, Australia, and Spain. Separately, Precision's ELIMINATE-B trial for chronic hepatitis B is ongoing with Phase 1 data expected in 2025.
iECURE reported positive preliminary results from its Phase 1/2 OTC-HOPE clinical trial for ECUR-506, a gene editing therapy for ornithine transcarbamylase (OTC) deficiency. The first infant treated showed a complete clinical response at the lowest dose level, demonstrating successful removal of ammonia scavenging medicines and normalization of protein intake after three months, with results maintained through the six-month study period.
The treatment was generally well-tolerated, with only asymptomatic transaminitis occurring at four weeks, which resolved within four weeks through immunosuppressive therapy. The OTC-HOPE trial is currently enrolling patients across four regions (US, UK, Spain, and Australia), with complete data readout expected in 1H 2026. The therapy targets neonatal onset OTC deficiency, affecting over 1,000 births globally per year.
ECUR-506 utilizes two AAV vectors: an ARCUS® nuclease vector licensed from Precision BioSciences (DTIL) and a donor vector for OTC gene insertion.
Precision BioSciences (DTIL) has received Clinical Trial Application approval in Hong Kong for PBGENE-HBV, marking the first in vivo gene editing approach for chronic hepatitis B in Hong Kong and their second CTA approval in 2024. The ELIMINATE-B Phase 1 trial is actively recruiting patients in Moldova and expanding to Hong Kong.
PBGENE-HBV, utilizing the ARCUS® platform, is designed to cure chronic hepatitis B by eliminating cccDNA and inactivating integrated HBV DNA in hepatocytes. The therapy targets a viral site prevalent across all HBV genotypes, particularly relevant for Asia where over 400,000 individuals in Hong Kong live with chronic hepatitis B.
The company expects to report clinical data throughout 2025 and anticipates a U.S. investigational new drug (IND) application in 2025.
Precision BioSciences (Nasdaq: DTIL), a clinical stage gene editing company, has announced its participation in two upcoming investor conferences in November 2024. The company will take part in the JonesTrading Virtual Genetic Medicine Day on November 25 at 11:00 AM ET, participating in a panel discussion titled 'Next Generation of Gene Editing; Going Beyond "Cas"'. Additionally, Precision will present at AussieMit on November 29 at 2:50 PM AEDT, discussing 'Emerging Therapies'. The JonesTrading event webcast will be available on Precision's investor website, with replay access for approximately 30 days.
Precision BioSciences (DTIL) has presented preclinical data for PBGENE-HBV, its gene editing therapy for chronic hepatitis B, and outlined its Phase 1 ELIMINATE-B trial design. The preclinical data showed 99% viral DNA editing in non-human primates, effective hepatocyte distribution, and sustained declines in viral biomarkers. The ELIMINATE-B trial will evaluate up to 45 HBeAg-negative patients across five countries, with data expected throughout 2025. The company has received clearance to begin trials in Moldova, with additional regulatory applications pending. The therapy targets approximately 300 million people globally affected by chronic hepatitis B, addressing an unmet need in a multi-billion-dollar market where current treatments achieve functional cure in less than 3% of patients.
Precision BioSciences (Nasdaq: DTIL), a clinical stage gene editing company, announced it will release its financial results for the third quarter of 2024 on November 4, 2024. The company utilizes its proprietary ARCUS® platform to develop in vivo gene editing therapies aimed at sophisticated gene edits. Along with the financial results, Precision BioSciences will also provide a business update.
Precision BioSciences (Nasdaq: DTIL) announced a virtual Hepatitis B Investor Event scheduled for November 15, 2024. The event will feature Key Opinion Leaders and members of Precision's Hepatitis Scientific Advisory Board discussing the current hepatitis B treatment landscape, which only achieves 1-3% functional cure rates. The presentation will focus on PBGENE-HBV, their gene editing approach targeting cccDNA elimination and HBV DNA inactivation. The company will present final preclinical safety data and phase 1 clinical trial plans following Clinical Trial Application approval in Moldova.
Precision BioSciences (Nasdaq: DTIL) presented preclinical data at the ESGCT 31st Annual Congress showcasing their ARCUS platform's capability for high-efficiency gene editing through homology-directed repair (HDR). The research demonstrated gene insertion rates exceeding 85% in T cells and 39% in non-dividing primary human hepatocytes.
The ARCUS platform showed versatility in DNA editing, achieving all twelve possible base changes, specific base removal and insertions, and whole gene replacements. This capability extends beyond current limitations of base editors and prime editors, potentially offering broader therapeutic applications for diseases requiring function restoration.
Precision BioSciences (NASDAQ: DTIL) has received its first Clinical Trial Application (CTA) approval in Moldova for PBGENE-HBV, marking the first in vivo gene editing program for chronic hepatitis B virus to enter global clinical trials. The program aims to cure chronic hepatitis B by eliminating cccDNA and inactivating integrated HBV DNA in hepatocytes using the proprietary ARCUS® platform. PBGENE-HBV delivers nuclease-encoding mRNA to the liver via lipid nanoparticles, targeting the HBV viral genome. The company is pursuing additional CTA and IND approvals globally to accelerate trial enrollment, aiming to provide a potential cure for nearly 300 million patients living with chronic hepatitis B.
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