Earnings summaries and quarterly performance for PRECISION BIOSCIENCES.
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Recent press releases and 8-K filings for DTIL.
Precision BioSciences receives FDA clearance for PBGENE-DMD clinical study
DTIL
Product Launch
New Projects/Investments
- Precision BioSciences, Inc. received a "Study May Proceed" notification from the U.S. FDA for its PBGENE-DMD program on February 11, 2026.
- This clearance enables the company to initiate clinical trial site activation for the FUNCTION-DMD Phase 1/2 clinical study for Duchenne muscular dystrophy (DMD).
- The company aims to activate the first U.S. clinical site in the first half of 2026, with initial data from multiple patients expected by year-end 2026.
- PBGENE-DMD is a first-in-class in vivo gene editing investigational product designed to correct the underlying genetic cause of DMD, and it has received FDA Rare Pediatric Disease and Orphan Drug designations.
Feb 11, 2026, 12:15 PM
Precision BioSciences Receives FDA Clearance for PBGENE-DMD IND Application
DTIL
New Projects/Investments
- Precision BioSciences (DTIL) has received U.S. FDA clearance of its Investigational New Drug (IND) application for PBGENE-DMD, enabling the initiation of clinical trial site activation for the FUNCTION-DMD Phase 1/2 clinical study for Duchenne muscular dystrophy (DMD).
- PBGENE-DMD is a first-in-class in vivo gene editing therapy designed to correct the underlying genetic cause of DMD by restoring near full-length functional dystrophin protein, targeting mutations between exons 45 and 55, which affect approximately 60% of DMD patients.
- The company aims to activate the first clinical site in the U.S. in the first half of 2026, with initial data from multiple patients expected by year-end 2026.
- PBGENE-DMD has also been granted FDA Rare Pediatric Disease (RPD) and Orphan Drug (ODD) designations.
Feb 11, 2026, 12:01 PM
Precision BioSciences Outlines 2026 Strategic Priorities and Financial Position
DTIL
New Projects/Investments
Guidance Update
- Precision BioSciences announced its 2026 strategic priorities will focus on the continued advancement of its clinical-stage programs, PBGENE-HBV for Chronic Hepatitis B and PBGENE-DMD for Duchenne Muscular Dystrophy.
- The company reported unaudited cash, cash equivalents, and restricted cash of approximately $137 million as of December 31, 2025, which is anticipated to provide a cash runway through 2028.
- For PBGENE-HBV, data updates from the Phase 1/2a ELIMINATE-B trial are expected at medical conferences in 2026, with additional biopsy data anticipated in the first half of 2026.
- For PBGENE-DMD, IND clearance is expected in Q1 2026 for its Phase 1/2 FUNCTION-DMD study, with initial data from multiple patients expected in 2026.
- Precision received an $8 million milestone payment in Q4 2025 from Imugene for Azer-Cel and is eligible for a $7.5 million near-term clinical milestone from TG Therapeutics.
Jan 13, 2026, 9:11 PM
Precision BioSciences Details 2026 Clinical Milestones and Financial Runway
DTIL
New Projects/Investments
Guidance Update
- Precision BioSciences is advancing its clinical-stage programs, PBGENE-HBV for chronic hepatitis B and PBGENE-DMD for Duchenne Muscular Dystrophy, with data updates and initial patient data expected in 2026.
- The company anticipates IND clearance in Q1 2026 for PBGENE-DMD, with the first patient expected to be dosed in late Q1 or early Q2 2026 for its Phase 1/2 FUNCTION-DMD study.
- As of December 31, 2025, Precision BioSciences reported approximately $137 million in unaudited cash, cash equivalents, and restricted cash, which is anticipated to provide a cash runway through 2028.
- Precision received an $8 million milestone payment in the fourth quarter of 2025 from Imugene for Azer-Cel and is eligible for a $7.5 million near-term clinical milestone from TG Therapeutics for the same program.
Jan 12, 2026, 12:01 PM
Precision BioSciences' Licensed Technology Receives FDA RMAT Designation
DTIL
Product Launch
New Projects/Investments
- iECURE, which licensed the ARCUS® nuclease from Precision BioSciences (Nasdaq: DTIL), has been granted FDA Regenerative Medicine Advanced Therapy (RMAT) designation for its investigational therapy ECUR-506 for neonatal onset ornithine transcarbamylase (OTC) deficiency.
- The RMAT designation provides intensive FDA guidance and expedited review, potentially accelerating the development and regulatory pathway for ECUR-506.
- iECURE also achieved alignment with the FDA on the OTC-HOPE study design, which could support a Biologics License Application (BLA) for ECUR-506.
- Furthermore, ECUR-506 received an Innovation Passport under the United Kingdom’s Innovative Licensing and Access Pathway (ILAP).
Jan 7, 2026, 1:00 PM
Precision BioSciences Provides Update on Gene Editing Programs and Financial Runway
DTIL
New Projects/Investments
Guidance Update
- Precision BioSciences (DTIL) is focused on advancing two in-vivo gene editing programs: PBGene-HBV for hepatitis B and PBGene-DMD for Duchenne muscular dystrophy.
- The company recently completed a $75 million financing, which is expected to provide a cash runway through 2028.
- Initial Phase 1 data for PBGene-HBV, presented on November 10th, demonstrated dose-dependent antiviral activity and a manageable safety profile, with further data readouts anticipated in 2026.
- For PBGene-DMD, an Investigational New Drug (IND) application is expected to be filed in 2025, with patient enrollment in the clinic beginning in early 2026 and the first data readout by the end of 2026.
Dec 11, 2025, 2:15 PM
Precision BioSciences Provides Updates on Gene Editing Programs and Financing
DTIL
New Projects/Investments
Guidance Update
- Precision BioSciences (DTIL) is focused on advancing two in-vivo gene editing programs: PBGene-HBV for hepatitis B and PBGene-DMD for Duchenne muscular dystrophy.
- The company recently secured $75 million in financing, which is expected to provide a cash runway through 2028.
- For PBGene-HBV, phase 1 data presented on November 10th showed the drug is well-tolerated with dose-dependent antiviral activity, and further data readouts are anticipated in 2026.
- An Investigational New Drug (IND) application for PBGene-DMD is expected to be filed in 2025, with clinical trials commencing in early 2026 and first data readouts by the end of 2026. A Biologics License Application (BLA) for PBGene-DMD could potentially be filed by the end of 2028.
Dec 11, 2025, 2:15 PM
Precision BioSciences Updates on Gene Editing Programs and Cash Runway
DTIL
New Projects/Investments
Guidance Update
- Precision BioSciences (DTIL) is advancing two in-vivo gene editing programs: PBGENE-HBV for hepatitis B and PBGENE-DMD for Duchenne muscular dystrophy.
- The company recently raised $75 million, securing a cash runway through 2028 to fund these programs.
- For PBGENE-HBV, Phase 1 data presented on November 10th, 2025, demonstrated the drug was well tolerated with dose-dependent antiviral activity, with additional data readouts anticipated in 2026.
- The PBGENE-DMD program is on track for an Investigational New Drug (IND) filing by the end of 2025, with clinical trials starting in early 2026 and initial data expected by the end of 2026. A Biologics License Application (BLA) filing is targeted by the end of 2028.
Dec 11, 2025, 2:15 PM
Precision BioSciences Announces $75 Million Offering of Common Stock, Pre-Funded Warrants, and Warrants
DTIL
New Projects/Investments
- Precision BioSciences, Inc. (DTIL) announced an underwritten offering of 10,815,000 shares of common stock and accompanying warrants, along with pre-funded warrants to purchase up to 1,400,000 shares of common stock and accompanying warrants. The offering is expected to close on or about November 12, 2025.
- The combined offering price is $6.14 for common stock and warrants, and $6.139995 for pre-funded warrants and warrants. Each whole warrant has an exercise price of $7.25 per share and will expire five years following the date of issuance.
- The company anticipates gross proceeds of approximately $75 million and estimated net proceeds of approximately $70.0 million from the offering.
- Net proceeds will be used to fund ongoing and planned research and development, working capital, and general corporate purposes.
Nov 12, 2025, 2:12 PM
Precision BioSciences Reports Positive Clinical Data for HBV Program and Secures $75 Million in Funding
DTIL
New Projects/Investments
Guidance Update
- Precision BioSciences presented positive late-breaking data from its Eliminate B trial for PBG.001-HBV at AASLD, highlighting dose-dependent antiviral effects, a manageable safety profile, and the first clinical biopsy evidence of gene editing in HBV.
- The company anticipates that data from cohort three of the PBG.001-HBV trial indicates a near-term path towards stopping nucleos(t)ide analogs (nukes) and testing for a cure, with dosing for this cohort projected to conclude in Q1 2026.
- Precision BioSciences secured $75 million through a public offering, extending its operational runway through 2028 to fund the PBG.001-HBV program through Phase 2 and the PBG.001-DMD program through pivotal trials to BLA submission.
- The PBG.001-DMD program is on track for an IND filing by the end of 2025 and expects to dose its first patient in Q1 2026, with initial patient data anticipated by the end of 2026.
Nov 11, 2025, 1:00 PM
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