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) has announced promising new preclinical data for PBGENE-DMD, their novel gene editing therapy for Duchenne Muscular Dystrophy (DMD). The data showed up to a three-fold increase in dystrophin-positive muscle cells between three and nine months across key muscle types, with up to 85% dystrophin-positive cells in the gastrocnemius.
PBGENE-DMD represents a first-in-class in vivo gene editing approach targeting up to 60% of DMD patients with mutations in the 'hot spot' region between exons 45-55. The therapy aims to permanently edit patients' DNA to produce functional, near full-length dystrophin protein. The company plans to submit an IND/CTA in 2025 with clinical data expected in 2026.
Precision BioSciences (Nasdaq: DTIL) has received FDA Rare Pediatric Disease Designation for PBGENE-DMD, its treatment for Duchenne muscular dystrophy (DMD). The company's ARCUS® gene editing platform aims to excise exons 45-55 of the dystrophin gene, potentially benefiting up to 60% of DMD patients.
The therapy targets a rare disease affecting fewer than 200,000 people in the U.S., with approximately 15,000 Americans living with DMD. Upon FDA approval, Precision may receive a Priority Review Voucher, which can be used for priority review of another product or sold to generate non-dilutive capital. Initial clinical data is expected in 2026.
Precision BioSciences (NASDAQ: DTIL) announced the acceleration of PBGENE-DMD, their first-in-class in vivo gene editing therapy for Duchenne Muscular Dystrophy (DMD). The therapy targets mutations in the 'hot spot' region between exons 45-55, which affects up to 60% of DMD patients. The company plans to submit an IND/CTA in 2025, with clinical data expected in 2026.
Preclinical data presented at ASGCT demonstrated significant and durable functional improvement in muscle function over 9 months in a humanized DMD mouse model. PBGENE-DMD uses two ARCUS nucleases delivered via AAV to restore dystrophin protein production. The company's current cash runway is expected to support both PBGENE-DMD and PBGENE-HBV through Phase 1 clinical readouts.
To focus resources, Precision will pause development of PBGENE-3243 for mitochondrial disease until after PBGENE-DMD enters the clinic.
Precision BioSciences (NASDAQ: DTIL), a clinical stage gene editing company, announced it will release its Q1 2025 financial results and provide a business update on May 15, 2025. The company specializes in developing in vivo gene editing therapies using its proprietary ARCUS® platform, focusing on diseases with high unmet medical needs.
Precision BioSciences (NASDAQ: DTIL) presented initial safety data from its Phase 1 ELIMINATE-B trial for PBGENE-HBV, a first-in-class gene editing therapy for chronic hepatitis B, at the 2025 EASL Congress. The trial's first cohort included three male participants (mean age 41) who received two of three planned doses at 0.2 mg/kg.
Key findings show PBGENE-HBV was well-tolerated with no serious adverse events. All adverse events were mild (grade 1 or 2) and transient, with no cumulative effects after the second dose. The data supports continued repeat dosing and dose escalation plans. Notably, the FDA granted Fast Track designation to PBGENE-HBV in April 2025. The trial is approved in the United States, Moldova, Hong Kong, New Zealand, and the United Kingdom.
iECURE announced it will present initial clinical data from its OTC-HOPE trial evaluating ECUR-506, an in vivo gene editing therapy for ornithine transcarbamylase (OTC) deficiency, at two major medical conferences. The presentations will take place at the ASGCT Annual Meeting (May 12-17, 2025) in New Orleans and the ESHG Conference (May 24-27, 2025) in Milan.
The presentations will expand on previously reported data from January 2025, which showed a complete clinical response in the first infant treated in the study. The company will showcase these results through a poster presentation and symposium at ASGCT, and an oral presentation at ESHG, led by Chief Medical Officer Gabriel Cohn and Dr. Julien Baruteau.
Initial safety data from ELIMINATE-B trial for chronic hepatitis B (PBGENE-HBV), their first-in-human study. Updates on ECUR-506, a partnered program with iECURE for OTC deficiency. Preclinical results from two muscle programs: PBGENE-3243 for mitochondrial disease and PBGENE-DMD for Duchenne Muscular Dystrophy.
The presentations demonstrate ARCUS platform's versatility in gene elimination, insertion, and excision across complex genetic diseases. The company aims to develop durable, curative treatments through various gene editing approaches.
Precision BioSciences (Nasdaq: DTIL), a clinical stage gene editing company, has announced new employee inducement awards approved by its Board's Compensation Committee on April 22, 2025. The awards were granted under the company's 2021 Employment Inducement Incentive Award Plan.
The inducement package includes 11,339 restricted stock units (RSUs) distributed among two new employees. These RSUs were granted under Nasdaq Listing Rule 5635(c)(4) as employment incentives. The vesting schedule for the RSUs is structured over a three-year period, with equal annual installments, contingent upon continued employment with Precision.
The company leverages its proprietary ARCUS® platform to develop in vivo gene editing therapies targeting diseases with high unmet medical needs.
Precision BioSciences (DTIL) has received Fast Track designation from the FDA for PBGENE-HBV, its lead in vivo gene editing therapy program targeting chronic hepatitis B. The therapy aims to cure the disease by eliminating cccDNA and inactivating integrated HBV DNA in hepatocytes.
The company is currently conducting the global Phase 1 ELIMINATE-B trial across multiple countries including the United States, Moldova, Hong Kong, New Zealand, and the United Kingdom. Initial results have shown encouraging safety and antiviral activity. Updates on the full low-dose cohort and higher dose levels are expected throughout 2025.
The Fast Track designation may enable more frequent FDA communications, rolling review of marketing applications, and potential Priority Review eligibility.
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