Precision Biosciences Stock Price, News & Analysis

Precision BioSciences (Nasdaq: DTIL) announced positive Phase 1 results from Cohort 1 of ELIMINATE-B, testing PBGENE-HBV for chronic hepatitis B treatment. The trial's lowest dose (0.2 mg/kg) demonstrated safety and efficacy across all three patients, with HBsAg reductions ranging from 47-69%.

Key highlights include durable HBsAg reduction of ~50% in one patient persisting 7 months after initial dosing. The drug was well-tolerated with no serious adverse events or dose-limiting toxicities. Cohort 2 (0.4 mg/kg) is progressing with similar safety profile. The company has extended its cash runway to second half of 2027 through a $25 million annual cost reduction program.

Additionally, Dr. Mark Sulkowski from Johns Hopkins University has expanded his role to Head Clinical Development Advisor to support the trial's advancement.

Precision BioSciences (Nasdaq: DTIL), a clinical stage gene editing company, will release its Q2 2025 financial results on August 7, 2025. The company, which develops in vivo gene editing therapies using its proprietary ARCUS® platform, will also provide a business update during the announcement.

Precision BioSciences (Nasdaq: DTIL) has received FDA Orphan Drug Designation for PBGENE-DMD, its gene editing therapy for Duchenne muscular dystrophy (DMD). This designation follows the company's recent Rare Pediatric Disease designation and provides benefits including financial incentives and potential 7-year market exclusivity.

The company is developing PBGENE-DMD using its proprietary ARCUS® platform for treating DMD, a rare disease affecting fewer than 200,000 people in the US. Precision BioSciences expects to report clinical data in 2026 and is maintaining active dialogue with the FDA as they progress toward regulatory milestones.

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.

<p>Precision BioSciences (DTIL) reported Q1 2025 financial results and significant progress in its gene editing programs. The company's lead program <b>PBGENE-HBV</b> for chronic Hepatitis B received FDA Fast Track Designation and regulatory clearance to expand trials globally. Initial safety data was presented at EASL, showing positive results after repeat dosing.</p> <p>The company is accelerating <b>PBGENE-DMD</b>, its Duchenne Muscular Dystrophy program, targeting IND/CTA filing in 2025 with clinical data expected in 2026. Preclinical data showed significant functional improvements and protein expression across multiple muscle types.</p> <p>Financially, Precision reported <b>$100 million</b> in cash and equivalents, with runway extended into H2 2026. Q1 2025 resulted in a net loss of <b>$20.6 million</b> ($2.21 per share), compared to net income of $8.6 million in Q1 2024. The company paused development of PBGENE-3243 to focus resources on its lead programs.</p>

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.