US Market News
1 week ago
Precision BioSciences Announces Inclusion in the Russell 2000® Index Expanding Market Visibility with Institutional InvestorsJune 29, 2026 7:01 AM
Business Wire Precision BioSciences, Inc. (Nasdaq: DTIL), a clinical stage gene editing company utilizing its novel proprietary ARCUS® platform to develop in vivo gene editing therapies for high unmet need diseases, today announced its addition to the Russell 2000® Index, effective at the close of U.S. equity markets on June 26, 2026, according to the final list of additions published by FTSE Russell. The annual reconstitution of the Russell U.S. indexes ranks eligible U.S. stocks by total market capitalization. Membership in the Russell 2000® Index, which remains in place for one year, means automatic inclusion in the appropriate growth and value style indexes. FTSE Russell determines membership for its Russell indexes primarily by objective, market-capitalization-based rules. The newly reconstituted Russell U.S. Indexes are expected to commence trading at the market open on Monday, June 29, 2026. "Being added to the Russell 2000 Index broadens our visibility with institutional investors at a pivotal time for Precision BioSciences," said Alex Kelly, Chief Financial Officer of Precision BioSciences. "We are advancing two wholly owned clinical programs, PBGENE-HBV in chronic hepatitis B and PBGENE-DMD in Duchenne muscular dystrophy, with a cash runway supporting our operations through 2028." For more information on the Russell indexes reconstitution, visit the FTSE Russell website. About Precision BioSciences, Inc. Precision BioSciences, Inc. is a clinical stage gene editing company dedicated to improving life (DTIL) with its novel and proprietary ARCUS® genome editing platform that differs from other technologies in the way it cuts, its smaller size, and its simpler structure. These features are intended for ARCUS nucleases to drive more defined therapeutic outcomes. Using ARCUS, the Company’s pipeline is comprised of clinical stage in vivo gene editing candidates designed to deliver lasting cures for the broadest range of genetic and infectious diseases where no adequate treatments exist. For more information about Precision BioSciences, please visit www.precisionbiosciences.com. The ARCUS® platform is being used to develop in vivo gene editing therapies for sophisticated gene edits, including gene elimination (removing a genome e.g. viral DNA such as in the Company’s PBGENE-HBV program), and excision (removing a large portion of a defective gene by delivering two ARCUS nucleases in a single AAV such as in the Company’s PBGENE-DMD program) and gene insertion (inserting DNA into gene to cause expression/add function). Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including, without limitation, statements regarding the key advantages of ARCUS and its key capabilities and differentiating characteristics; expectations about operational initiatives, strategies, further development, or timing of additional updates or data releases; and statements regarding a cash runway supporting operations through 2028. In some cases, you can identify forward-looking statements by terms such as “aim,” “anticipate,” “approach,” “belief”, “believe,” “contemplate,” “could,” “design,” “designed,” “estimate,” “expect,” “goal,” “intend,” “look,” “may,” “mission,” “plan,” “possible,” “potential,” “predict,” “project,” “pursue,” “should,” “strive,” “suggest,” “target,” “will,” “would,” or the negative thereof and similar words and expressions. Forward-looking statements are based on management’s current expectations, beliefs, and assumptions and on information currently available to us. These statements are neither promises nor guarantees, and involve a number of known and unknown risks, uncertainties and assumptions, and actual results may differ materially from those expressed or implied in the forward-looking statements due to various important factors, including, but not limited to, our ability to become profitable; our ability to procure sufficient funding to advance our programs; risks associated with our capital requirements, anticipated cash runway, requirements under our current debt instruments and effects of restrictions thereunder, including our ability to raise additional capital due to market conditions and/or our market capitalization; our operating expenses and our ability to predict what those expenses will be; our limited operating history; the progression and success of our programs and product candidates in which we expend our resources; our limited ability or inability to assess the safety and efficacy of our product candidates; the risk that other genome-editing technologies may provide significant advantages over our ARCUS technology; our dependence on our ARCUS technology; the initiation, cost, timing, progress, achievement of milestones and results of research and development activities and preclinical and clinical studies, including clinical trial and investigational new drug applications; public perception about genome editing technology and its applications; competition in the genome editing, biopharmaceutical, and biotechnology fields; our or our collaborators’ or other licensees’ ability to identify, develop and commercialize product candidates; pending and potential product liability lawsuits and penalties against us or our collaborators or other licensees related to our technology and our product candidates; the U.S. and foreign regulatory landscape applicable to our and our collaborators’ or other licensees’ development of product candidates; our or our collaborators’ or other licensees’ ability to advance product candidates into, and successfully design, implement and complete, clinical trials; potential manufacturing problems associated with the development or commercialization of any of our product candidates; delays or difficulties in our and our collaborators’ and other licensees’ ability to enroll patients; changes in interim “top-line” and initial data that we announce or publish; if our product candidates do not work as intended or cause undesirable side effects; risks associated with applicable healthcare, data protection, privacy and security regulations and our compliance therewith; our or our licensees’ ability to obtain orphan drug designation or fast track designation for our product candidates or to realize the expected benefits of these designations; our or our collaborators’ or other licensees’ ability to obtain and maintain regulatory approval of our product candidates, and any related restrictions, limitations and/or warnings in the label of an approved product candidate; the rate and degree of market acceptance of any of our product candidates; our ability to effectively manage the growth of our operations; our ability to attract, retain, and motivate executives and personnel; effects of system failures and security breaches; insurance expenses and exposure to uninsured liabilities; effects of tax rules; effects of any pandemic, epidemic, or outbreak of an infectious disease; the success of our existing collaboration and other license agreements, and our ability to enter into new collaboration arrangements; our current and future relationships with and reliance on third parties including suppliers and manufacturers; our ability to obtain and maintain intellectual property protection for our technology and any of our product candidates; potential litigation relating to infringement or misappropriation of intellectual property rights; effects of natural and manmade disasters, public health emergencies and other natural catastrophic events; effects of sustained inflation, supply chain disruptions and major central bank policy actions; market and economic conditions; risks related to ownership of our common stock, including fluctuations in our stock price; our ability to meet the requirements of and maintain listing of our common stock on Nasdaq or other public stock exchanges; and other important factors discussed under the caption “Risk Factors” in our Quarterly Report on Form 10-Q for the quarterly period ended March 31, 2026, as any such factors may be updated from time to time in our other filings with the SEC, which are accessible on the SEC’s website at www.sec.gov and the Investors page of our website under SEC Filings at investor.precisionbiosciences.com. All forward-looking statements speak only as of the date of this press release and, except as required by applicable law, we have no obligation to update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise. View source version on businesswire.com: https://www.businesswire.com/news/home/20260629704963/en/ Investor and Media Contact:
Naresh Tanna
Vice President of Investor Relations
naresh.tanna@precisionbiosciences.com Original: Precision BioSciences Announces Inclusion in the Russell 2000® Index Expanding Market Visibility with Institutional Investors
jondoeuk
1 month ago
''A new method of CRISPR-based gene editing shows promise in curtailing chronic hepatitis B infections. Its twist is to silence disease-causing genes without altering the underlying DNA.
Tune Therapeutics said the therapy showed some evidence of antiviral activity in nearly all patients based on blood biomarkers. Some of those responses have remained durable for as long as 17 months so far.
“I’m very impressed. With a single infusion, they achieve a profound reduction of some of the most important biomarkers in HBV,” Pietro Lampertico, a gastroenterologist and HBV researcher at the University of Milan who wasn’t involved in the study, told Endpoints News. “This is the first time ever in the HBV field that we have this data.”
The results of the Phase 1b/2a study were presented at the European Association for the Study of the Liver Congress in Barcelona on Saturday. Tune’s data provide one of the clearest demonstrations yet that epigenetic editing can work in people.
“We could potently and specifically silence a gene of interest by epigenetic silencing,” Tune CEO John McHutchison told Endpoints. “We now have the backbone mechanism to cure patients with hepatitis B. We haven’t had that before.”
But the degree of viral repression depended on the dose, the biomarker, and varied widely among patients within a dose level. That variability suggests that even if Tune is successful at creating a functional cure for some patients, the complexities of chronic HBV infections may make a cure for all patients difficult to achieve.
“The effect at the higher doses starts to become deeper, and more people are approaching 100% repression. But there is variability,” McHutchison said. “So we haven’t sorted that out yet.” The company is still giving some patients additional infusions and testing a higher dose, which he hopes will lead to “a larger response across the vast majority of patients.”
Tune also saw some people clear a viral protein called HBeAg whose presence indicates an actively replicating and contagious virus. The company said that three of the five patients who tested positive for HBeAg at the start of the study lost the protein after treatment — suggesting the therapy suppressed the viral DNA.
“This happened rather quickly,” McHutchison said. “There’s less viral replication, less ongoing damage, so it’s a good thing for patients.”
Suppressing a stubborn infection
Although there are vaccines and antivirals for HBV, more than 240 million people worldwide and 640,000 adults in the US have chronic infections. These chronic infections are a major cause of cirrhosis and liver cancer.
Once the virus takes hold, it is practically impossible to eliminate, due to the stubborn persistence of viral DNA in liver cells. Even when the virus itself is cleared, that genetic reservoir allows new virus to be made.
Tune’s therapy takes aim at that reservoir. The experimental treatment targets viral genomes known as covalently closed circular DNA (cccDNA) that sit alongside human chromosomes, as well as viral genes that have snuck themselves into the human genome.
“For the last 15 years, when I was at Gilead and other companies, we screened tens of millions of molecules to try and come up with an approach to silence cccDNA, because we knew to cure, we had to do that. And we were never able to do that,” McHutchison said. “Now we can.”
The therapy, called TUNE-401, uses CRISPR’s homing ability to target these viral genes. Two other piggybacking proteins shut down those genes: One lays chemical markers atop the viral DNA in a gene-silencing process called methylation; the second compresses the DNA into a compact structure, which prevents the code from being read.
Tune believes this so-called epigenetic editing will be safer than gene editing technologies that cut or change the DNA code itself.
The trial in detail
The trial was conducted in New Zealand, Hong Kong and Moldova. Tune tested four dose levels of its therapy, administered as a single intravenous infusion, in 19 people. Another seven people got up to three infusions of the second-highest dose given at least four weeks apart.
The therapy produced the starkest results in a biomarker known as pregenomic RNA, the blueprint made from the viral cccDNA used to make viral proteins. Four of 18 patients had pgRNA cut by 100% for at least two timepoints, and the biomarker was reduced by 99% in three other people. The biomarker was lowered by at least 70% in nearly all the patients.
The data provide the most direct evidence that Tune’s therapy is suppressing the cccDNA. To get a drug approved for hepatitis B, the FDA requires drugmakers to show that a treatment eliminates the viral DNA in the blood for six months, McHutchison said. But the patients in Tune’s trial were already DNA-negative because they were taking standard antivirals. By clamping down the production of pgRNA, the therapy should prevent more virus from being made, and thus keep viral DNA levels undetectable, McHutchison said.
“We’re talking with the investigators about considering stopping therapy on people who are durably negative for some of these biomarkers,” McHutchison said. “We didn’t expect to do that in this first study.”
Markus Cornberg, a hepatitis researcher at Hannover Medical School in Germany who saw Tune’s presentation, told Endpoints the therapy is “one of the more innovative approaches currently being explored in the HBV cure field.”
He cautioned against overinterpreting the small study, but said if the results are confirmed in a bigger trial, “this would represent an important advance.”
Another biomarker that Tune examined was a viral surface protein called HBsAg, which can be made from both cccDNA and the integrated viral DNA. The treatment lowered the protein by 90% or more in two patients, and between 26% and 77% across other patients.
Lampertico said data suggest Tune’s therapy is better at silencing the cccDNA and not as good at repressing the integrated viral genes, which means it stops short of a full cure. But he thinks that suppressing cccDNA is most important for preventing lethal complications of the disease, including liver cancer.
Three patients experienced severe adverse events deemed related to the therapy, including one who was hospitalized due to an infusion-related reaction and two patients who experienced a sudden blood pressure drop after infusion. All three symptoms resolved within about a day.
In four instances, patients experienced grade 3 or higher elevations of the liver enzymes ALT and AST, which can indicate severe liver injury — a common problem for genetic medicines targeting the liver. McHutchison said the patients recovered without symptoms.
Epigenetic medicines
Tune raised $175 million in January 2025, making it one of the most well-funded gene editing startups during a period when investors have grown increasingly disillusioned with the field.
But Tune hasn’t been immune to the cuts that have impacted most gene editing companies. The startup told Endpoints it had 80 employees at the time of its last funding, but it is now down to 54 people split between sites in Seattle and Durham, NC.
McHutchison said the company plans to raise more funding in a Series C round to support a Phase 2 study of about 150 to 200 patients. Depending on feedback from the FDA, he hopes that study will start in the first half of next year.
Others have also tested epigenetic gene editing in humans. A young man named Terry Horgan who had a rare form of muscular dystrophy got a personalized epigenetic editing therapy in 2022 from a nonprofit started by his brother, but he died from an immune reaction to the high dose of viral vector used to get the therapy to muscles throughout his body.
Omega Therapeutics said in 2023 that its therapy reduced expression of the cancerous MYC gene in liver cancer. But the company shut down last year. Epicrispr Biotechnologies, which is developing a therapy for a form of muscular dystrophy, said in January that three patients have experienced improvements. But the startup didn’t share specific details.
Two other well-funded epigenetic editing companies, Boston-based nChroma Bio and Shanghai-based Epigenic Therapeutics, are also testing treatments for chronic HBV in the clinic.
These epigenetic medicines are likely to face competition from more established technologies, including GSK’s experimental drug bepirovirsen, which is an antisense oligonucleotide therapy that stops viral RNA from getting turned into viral proteins. The weekly treatment resulted in a functional cure in 19% of patients across two large Phase 3 studies.
The bepirovirsen data, also presented at the EASL meeting last week, were heralded as a major advance for the disease and set a bar for Tune and its competitors to beat. But the fact that most patients on bepirovirsen didn’t achieve a functional cure suggests there’s much room for improvement.
The bepirovirsen data are “a nice step forward,” McHutchison said. He added that combination therapies turned hepatitis C into a curable disease for most patients. “That’s an approach and a thesis that will stand for hepatitis B as well,” and one that Tune will explore in future trials, he said. https://endpoints.news/epigenetic-editing-shows-promise-against-chronic-hep-b-infections/
US Market News
2 months ago
Precision BioSciences Announces Oral Presentation at the American Society of Gene and Cell Therapy (ASGCT) 2026 Annual MeetingApril 28, 2026 7:01 AM
Business Wire
Precision BioSciences, Inc. (Nasdaq: DTIL), a clinical stage gene editing company utilizing its novel proprietary ARCUS® platform to develop in vivo gene editing therapies for high unmet need diseases, today announced that new preclinical data from its PBGENE-DMD program have been accepted for an oral presentation at the American Society of Gene & Cell Therapy (ASGCT) 2026 Annual Meeting, taking place May 11-15, 2026, in Boston, Massachusetts. The accepted abstract highlights new data demonstrating compelling efficacy observed in early-juvenile mice supporting the potential benefit of earlier intervention with PBGENE-DMD in younger patient populations. These data build on previously shared updates showing treatment with PBGENE-DMD leads to durable functional improvement in a humanized Duchenne muscular dystrophy (DMD) mouse model.
Details of the presentation:
Abstract title: PBGENE-DMD gene editing drives safe, efficacious, and durable functional improvement in a humanized Duchenne muscular dystrophy mouse model
Session: Emerging molecular therapeutic strategies for muscular dystrophies
Presenter: Adam Michler Ph.D., DMD Research Lead
Presentation Type: Oral Presentation
Presentation Time: May 14, 2026 at 8:45 a.m. ET
About PBGENE-DMD, A Muscle-Targeted Excision Program
PBGENE-DMD is Precision's development program for the treatment of Duchenne Muscular Dystrophy (DMD), a devastating genetic disease caused by mutations in the dystrophin gene that prevents production of the dystrophin protein, which is essential for maintaining muscle structural integrity and function. DMD affects approximately 15,000 patients in the U.S. alone, and there are currently no approved therapies capable of driving significant, durable functional improvements over time.
PBGENE-DMD is designed to durably improve function for approximately 60% of patients with DMD by employing two complementary ARCUS nucleases, delivered using a single AAV, to excise exons 45-55 of the dystrophin gene, restoring expression of a near full-length dystrophin protein. This protein more closely resembles normal dystrophin than synthetic, truncated microdystrophin approaches, which offer minimal functional benefit. Precision’s Phase 1/2 FUNCTION-DMD study is expected to enroll ambulatory DMD patients with mutations between exons 45 and 55, which impact approximately 60% of boys with DMD. The clinical trial will employ an appropriate immune modulation regimen and safety monitoring program to treat patients at world class specialized DMD clinical sites.
PBGENE-DMD was granted Orphan Drug Designation by the FDA in July 2025. The PBGENE-DMD program is eligible for a Priority Review Voucher (PRV) via the Rare Pediatric Disease Priority Review Voucher (PRV) program, which was signed into law on February 3, 2026, as part of the Consolidated Appropriations Act of 2026. PBGENE-DMD received Fast Track designation from the FDA in February 2026.
Further details on the trial can be found on Precision’s website and clinicaltrials.gov identifier NCT07429240.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including, without limitation, the design of PBGENE-DMD to improve function over time and address approximately 60% of patients with DMD; the potential for PBGENE-DMD to provide durable functional improvement with a single dose of AAV; translation of results in preclinical studies of ARCUS nucleases including safety, efficacy and durable functional improvement to clinical studies in humans; the employment of an appropriate immune modulation regimen and safety monitoring program to treat ambulatory patients at world class specialized DMD clinical sites; the eligibility of PBGENE-DMD for a Priority Review Voucher (PRV) via the Rare Pediatric Disease Priority Review Voucher (PRV) program; and the preclinical and clinical development and demonstrated, potential and expected safety, efficacy, durability, and benefit of PBGENE-DMD. In some cases, you can identify forward-looking statements by terms such as “aim,” “anticipate,” “approach,” “belief”, “believe,” “contemplate,” “could,” “design,” “designed,” “estimate,” “expect,” “goal,” “intend,” “look,” “may,” “mission,” “plan,” “possible,” “potential,” “predict,” “project,” “pursue,” “should,” “strive,” “suggest,” “target,” “will,” “would,” or the negative thereof and similar words and expressions.
Forward-looking statements are based on management’s current expectations, beliefs, and assumptions and on information currently available to us. These statements are neither promises nor guarantees, and involve a number of known and unknown risks, uncertainties and assumptions, and actual results may differ materially from those expressed or implied in the forward-looking statements due to various important factors, including, but not limited to, our ability to become profitable; our ability to procure sufficient funding to advance our programs; risks associated with our capital requirements, anticipated cash runway, requirements under our current debt instruments and effects of restrictions thereunder, including our ability to raise additional capital due to market conditions and/or our market capitalization; our operating expenses and our ability to predict what those expenses will be; our limited operating history; the progression and success of our programs and product candidates in which we expend our resources; our limited ability or inability to assess the safety and efficacy of our product candidates; the risk that other genome-editing technologies may provide significant advantages over our ARCUS technology; our dependence on our ARCUS technology; the initiation, cost, timing, progress, achievement of milestones and results of research and development activities and preclinical and clinical studies, including clinical trial and investigational new drug applications; public perception about genome editing technology and its applications; competition in the genome editing, biopharmaceutical, and biotechnology fields; our or our collaborators’ or other licensees’ ability to identify, develop and commercialize product candidates; pending and potential product liability lawsuits and penalties against us or our collaborators or other licensees related to our technology and our product candidates; the U.S. and foreign regulatory landscape applicable to our and our collaborators’ or other licensees’ development of product candidates; our or our collaborators’ or other licensees’ ability to advance product candidates into, and successfully design, implement and complete, clinical trials; potential manufacturing problems associated with the development or commercialization of any of our product candidates; delays or difficulties in our and our collaborators’ and other licensees’ ability to enroll patients; changes in interim “top-line” and initial data that we announce or publish; if our product candidates do not work as intended or cause undesirable side effects; risks associated with applicable healthcare, data protection, privacy and security regulations and our compliance therewith; our or our licensees’ ability to obtain orphan drug designation or fast track designation for our product candidates or to realize the expected benefits of these designations; our or our collaborators’ or other licensees’ ability to obtain and maintain regulatory approval of our product candidates, and any related restrictions, limitations and/or warnings in the label of an approved product candidate; the rate and degree of market acceptance of any of our product candidates; our ability to effectively manage the growth of our operations; our ability to attract, retain, and motivate executives and personnel; effects of system failures and security breaches; insurance expenses and exposure to uninsured liabilities; effects of tax rules; effects of any pandemic, epidemic, or outbreak of an infectious disease; the success of our existing collaboration and other license agreements, and our ability to enter into new collaboration arrangements; our current and future relationships with and reliance on third parties including suppliers and manufacturers; our ability to obtain and maintain intellectual property protection for our technology and any of our product candidates; potential litigation relating to infringement or misappropriation of intellectual property rights; effects of natural and manmade disasters, public health emergencies and other natural catastrophic events; effects of sustained inflation, supply chain disruptions and major central bank policy actions; market and economic conditions; risks related to ownership of our common stock, including fluctuations in our stock price; our ability to meet the requirements of and maintain listing of our common stock on Nasdaq or other public stock exchanges; and other important factors discussed under the caption “Risk Factors” in our Quarterly Report on Form 10-K for the annual period ended December 31, 2025, as any such factors may be updated from time to time in our other filings with the SEC, which are accessible on the SEC’s website at www.sec.gov and the Investors page of our website under SEC Filings at investor.precisionbiosciences.com.
All forward-looking statements speak only as of the date of this press release and, except as required by applicable law, we have no obligation to update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise.
View source version on businesswire.com: https://www.businesswire.com/news/home/20260428083428/en/
Investor and Media Contact:
Naresh Tanna
Vice President of Investor Relations
naresh.tanna@precisionbiosciences.com
Original: Precision BioSciences Announces Oral Presentation at the American Society of Gene and Cell Therapy (ASGCT) 2026 Annual Meeting
US Market News
2 months ago
Precision BioSciences Announces Grant of Inducement Awards Under Nasdaq Listing Rule 5635(c)(4)April 24, 2026 7:01 AM
Business Wire
Precision BioSciences, Inc. (Nasdaq: DTIL), a clinical stage gene editing company utilizing its novel proprietary ARCUS® platform to develop in vivo gene editing therapies for high unmet need diseases, today announced that, on April 20, 2026, the Compensation Committee of Precision’s Board of Directors approved the grant of an inducement award of 7,094 restricted stock units (“RSUs”) to a new employee under the Precision BioSciences, Inc. 2021 Employment Inducement Incentive Award Plan (“Inducement Award Plan”) in connection with their commencement of employment. The award was granted under Nasdaq Listing Rule 5635(c)(4) as an inducement for the employee to commence service with Precision.
The employee’s RSUs vest (subject to continued service to Precision through the applicable vesting dates) in substantially equal annual installments on each of the first three anniversaries of the date of the commencement of their employment.
About Precision BioSciences, Inc.
Precision BioSciences, Inc. is a clinical stage gene editing company dedicated to improving life (DTIL) with its novel and proprietary ARCUS® genome editing platform that differs from other technologies in the way it cuts, its smaller size, and its simpler structure. These features are intended for ARCUS nucleases to drive more defined therapeutic outcomes. Using ARCUS, the Company’s pipeline is comprised of clinical stage in vivo gene editing candidates designed to deliver lasting cures for the broadest range of genetic and infectious diseases where no adequate treatments exist. For more information about Precision BioSciences, please visit www.precisionbiosciences.com.
The ARCUS® platform is being used to develop in vivo gene editing therapies for sophisticated gene edits, including gene elimination (removing a genome e.g. viral DNA such as in the Company’s PBGENE-HBV program), and excision (removing a large portion of a defective gene by delivering two ARCUS nucleases in a single AAV such as in the Company’s PBGENE-DMD program) and gene insertion (inserting DNA into gene to cause expression/add function).
View source version on businesswire.com: https://www.businesswire.com/news/home/20260424485307/en/
Investor and Media Contact:
Naresh Tanna
Vice President, Investor Relations
Naresh.Tanna@precisionbiosciences.com
Original: Precision BioSciences Announces Grant of Inducement Awards Under Nasdaq Listing Rule 5635(c)(4)
US Market News
3 months ago
Precision BioSciences Expands ELIMINATE-B Trial Following Clinical Trial Application Approval in Two European CountriesApril 15, 2026 7:01 AM
Business Wire
- France and Romania planned for inclusion in the global ELIMINATE-B trial supporting broader patient enrollment -
Precision BioSciences, Inc. (Nasdaq: DTIL), a clinical stage gene editing company utilizing its novel proprietary ARCUS® platform to develop in vivo gene editing therapies for high unmet need diseases, today announced that it has received Clinical Trial Application (CTA) approval to expand the ongoing global ELIMINATE-B clinical trial of PBGENE-HBV. The regulatory authorization will allow Precision to initiate important hepatitis B clinical trial sites in France and Romania. This expansion broadens the trial’s global footprint deeper into Europe, adding to existing clinical trial sites in the United Kingdom, Moldova, New Zealand, Hong Kong and the United States.
The Company expects the addition of clinical trial sites in France and Romania to support continued patient enrollment and clinical execution in ELIMINATE-B with the goal to treat as many clinical trial patients as possible with PBGENE-HBV. Site initiation activities are underway, with initial patient screening expected in Q2 2026.
“Expanding ELIMINATE-B into hepatitis sites in France and Romania is an important step in the continued development of PBGENE-HBV, the only gene editing therapy uniquely designed to eliminate cccDNA,” said Cindy Atwell, Chief Development and Business Officer of Precision BioSciences. “Given the strong investigator interest in PBGENE-HBV, especially following the late breaker oral presentation at The Liver Conference 2025, these new trial sites will build on our existing global clinical trial footprint as we advance PBGENE-HBV through the ELIMINATE-B trial.”
About Chronic Hepatitis B
Chronic hepatitis B virus causes inflammation and damage to the liver, leading to chronic infection and increased risk of death from liver cancer or cirrhosis. There is no cure for chronic hepatitis B, and current treatments rarely result in a functional cure, primarily due to persistence of viral DNA in the liver. In patients with chronic hepatitis B, genetic material of the virus is converted within infected liver cells into cccDNA that acts as the only template to make new infectious viral particles. Hepatitis B virus also inserts fragments of its DNA into the human genome of infected liver cells. These integrated fragments are viral replication incompetent and cannot produce new infectious virus. Both cccDNA and integrated HBV DNA produce the viral protein, hepatitis B surface antigen (“HBsAg”), which is secreted into the blood.
Historically, the focus for drug development and regulatory approval of drugs for chronic hepatitis B has relied on the suppression of HBsAg. Achieving undetectable HBsAg may lead to a functional cure if there is no rebound in HBV DNA or HBsAg after drug treatment has been discontinued for at least six months, but this is achieved in less than three out of 100 patients treated with the current standard of care. Since cccDNA is the only source of infectious particles (HBV DNA), we believe that elimination of cccDNA could result in a cure of chronic hepatitis B. Sustained loss of HBV DNA alone as a result of cccDNA elimination is also a potentially approvable endpoint for the FDA and highly relevant for PBGENE-HBV.
About PBGENE-HBV, A Viral Elimination Program
PBGENE-HBV is Precision’s wholly owned in vivo gene editing program under investigation in a global first-in-human clinical trial, which is designed to be a potentially curative treatment for chronic hepatitis B infection. PBGENE-HBV is the first and only potentially curative gene editing program to enter the clinic that is specifically designed to eliminate the root cause of chronic hepatitis B, cccDNA, while inactivating integrated HBV DNA. Elimination of cccDNA results in HBV cure as cccDNA is the only source of infectious replication (HBV DNA). The ELIMINATE-B trial is investigating PBGENE-HBV at multiple dose levels across a number of administrations per dose level in patients with chronic hepatitis B. PBGENE-HBV has been granted Fast Track designation by the FDA.
PBGENE-HBV is the only clinical stage program targeting the elimination of cccDNA leading to sustained loss of HBV DNA. The FDA has previously provided guidance that sustained loss of HBV DNA is an approvable endpoint for chronic hepatitis B.
Further details on the trial can be found on Precision’s website and on clinicaltrials.gov identifier NCT06680232.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including, without limitation, expectations about operational initiatives, strategies, further development, or timing of additional updates or data releases of PBGENE-HBV; the expectation that the addition of sites in France and Romania support broader patient enrollment in ELIMINATE-B and continued clinical execution; the goal to treat as many clinical trial patients as possible with PBGENE-HBV following the addition of sites in France and Romania; the strong investigator interest in PBGENE-HBV; the belief that since cccDNA is the only source of infectious particles (HBV DNA), elimination of cccDNA could result in a cure of chronic hepatitis B; the belief that PBGENE-HBV is the only clinical stage program targeting the elimination of cccDNA leading to sustained loss of HBV DNA; the potential that sustained loss of HBV DNA alone as a result of cccDNA elimination is an approvable endpoint for the FDA and highly relevant for PBGENE-HBV; the design of PBGENE-HBV to be a potentially curative treatment for chronic hepatitis B infection; the expectation that site initiation activities are underway in France and Romania, with initial patient screening expected in Q2 2026; and the design of PBGENE-HBV to be the first and only potentially curative gene editing program to enter the clinic that is specifically designed to eliminate the root cause of chronic hepatitis B. In some cases, you can identify forward-looking statements by terms such as “aim,” “anticipate,” “approach,” “belief”, “believe,” “contemplate,” “could,” “design,” “designed,” “estimate,” “expect,” “goal,” “intend,” “look,” “may,” “mission,” “plan,” “possible,” “potential,” “predict,” “project,” “pursue,” “should,” “strive,” “suggest,” “target,” “will,” “would,” or the negative thereof and similar words and expressions.
Forward-looking statements are based on management’s current expectations, beliefs, and assumptions and on information currently available to us. These statements are neither promises nor guarantees, and involve a number of known and unknown risks, uncertainties and assumptions, and actual results may differ materially from those expressed or implied in the forward-looking statements due to various important factors, including, but not limited to, our ability to become profitable; our ability to procure sufficient funding to advance our programs; risks associated with our capital requirements, anticipated cash runway, requirements under our current debt instruments and effects of restrictions thereunder, including our ability to raise additional capital due to market conditions and/or our market capitalization; our operating expenses and our ability to predict what those expenses will be; our limited operating history; the progression and success of our programs and product candidates in which we expend our resources; our limited ability or inability to assess the safety and efficacy of our product candidates; the risk that other genome-editing technologies may provide significant advantages over our ARCUS technology; our dependence on our ARCUS technology; the initiation, cost, timing, progress, achievement of milestones and results of research and development activities and preclinical and clinical studies, including clinical trial and investigational new drug applications; public perception about genome editing technology and its applications; competition in the genome editing, biopharmaceutical, and biotechnology fields; our or our collaborators’ or other licensees’ ability to identify, develop and commercialize product candidates; pending and potential product liability lawsuits and penalties against us or our collaborators or other licensees related to our technology and our product candidates; the U.S. and foreign regulatory landscape applicable to our and our collaborators’ or other licensees’ development of product candidates; our or our collaborators’ or other licensees’ ability to advance product candidates into, and successfully design, implement and complete, clinical trials; potential manufacturing problems associated with the development or commercialization of any of our product candidates; delays or difficulties in our and our collaborators’ and other licensees’ ability to enroll patients; changes in interim “top-line” and initial data that we announce or publish; if our product candidates do not work as intended or cause undesirable side effects; risks associated with applicable healthcare, data protection, privacy and security regulations and our compliance therewith; our or our licensees’ ability to obtain orphan drug designation or fast track designation for our product candidates or to realize the expected benefits of these designations; our or our collaborators’ or other licensees’ ability to obtain and maintain regulatory approval of our product candidates, and any related restrictions, limitations and/or warnings in the label of an approved product candidate; the rate and degree of market acceptance of any of our product candidates; our ability to effectively manage the growth of our operations; our ability to attract, retain, and motivate executives and personnel; effects of system failures and security breaches; insurance expenses and exposure to uninsured liabilities; effects of tax rules; effects of any pandemic, epidemic, or outbreak of an infectious disease; the success of our existing collaboration and other license agreements, and our ability to enter into new collaboration arrangements; our current and future relationships with and reliance on third parties including suppliers and manufacturers; our ability to obtain and maintain intellectual property protection for our technology and any of our product candidates; potential litigation relating to infringement or misappropriation of intellectual property rights; effects of natural and manmade disasters, public health emergencies and other natural catastrophic events; effects of sustained inflation, supply chain disruptions and major central bank policy actions; market and economic conditions; risks related to ownership of our common stock, including fluctuations in our stock price; our ability to meet the requirements of and maintain listing of our common stock on Nasdaq or other public stock exchanges; and other important factors discussed under the caption “Risk Factors” in our Quarterly Report on Form 10-K for the annual period ended December 31, 2025, as any such factors may be updated from time to time in our other filings with the SEC, which are accessible on the SEC’s website at www.sec.gov and the Investors page of our website under SEC Filings at investor.precisionbiosciences.com.
All forward-looking statements speak only as of the date of this press release and, except as required by applicable law, we have no obligation to update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise.
View source version on businesswire.com: https://www.businesswire.com/news/home/20260415450685/en/
Investor and Media Contact:
Naresh Tanna
Vice President of Investor Relations
naresh.tanna@precisionbiosciences.com
Original: Precision BioSciences Expands ELIMINATE-B Trial Following Clinical Trial Application Approval in Two European Countries
US Market News
4 months ago
Precision BioSciences Receives U.S. Patent Allowances Covering the PBGENE-HBV ProgramMarch 11, 2026 7:01 AM
Business Wire
Precision BioSciences, Inc. (Nasdaq: DTIL), a clinical stage gene editing company utilizing its novel proprietary ARCUS® platform to develop in vivo gene editing therapies for high unmet need diseases, today announced that it has received two Notices of Allowance from the U.S. Patent and Trademark Office (USPTO) for patent applications relating to the Company’s PBGENE-HBV program.
The first Notice of Allowance relates to U.S. Patent Application No. 19/347,136, titled “Engineered meganucleases having specificity for a recognition sequence in the Hepatitis B virus genome.” The ’136 application includes composition of matter claims that, when granted, will encompass the ARCUS nuclease utilized in PBGENE-HBV.
The second Notice of Allowance relates to U.S. Patent Application No. 19/273,982, titled “Polypeptide linkers for use in engineered meganucleases.” The ’982 application includes composition of matter claims that, when granted, will encompass any polypeptide—including the PBGENE-HBV ARCUS nuclease—that comprises a novel, shortened polypeptide linker developed by Precision. Future ARCUS nucleases incorporating this novel polypeptide linker will also be covered by the granted claims.
When issued, each patent arising from these applications is expected to have a standard expiration date in November 2044.
“The U.S. patents arising from these two applications represent another important step in strengthening our intellectual property estate supporting PBGENE-HBV,” said Jeff Smith, PhD, Co-Founder and Chief Research Officer of Precision BioSciences. “When issued, these patents will provide meaningful composition-of-matter protection for the PBGENE-HBV ARCUS nuclease through at least 2044 and provide additional overlapping coverage of this key program across multiple patent families.”
About PBGENE-HBV, A Hepatitis B Viral Elimination Program
PBGENE-HBV is Precision’s wholly owned in vivo gene editing program under investigation in a global first-in-human clinical trial, which is designed to be a potentially curative treatment for chronic Hepatitis B infection. In patients with chronic hepatitis B, cccDNA acts as a template to make new infectious viral particles. PBGENE-HBV is the only clinical stage program to date that targets the elimination of cccDNA, the sole source of viral replication, leading to sustained loss of HBV DNA and other downstream viral transcripts. PBGENE-HBV has been granted Fast Track designation by the FDA.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including, without limitation, expectations about operational initiatives, strategies, and further development of PBGENE-HBV; the design of PBGENE-HBV to be a potentially curative treatment for chronic Hepatitis B infection and to eliminate cccDNA while inactivating integrated HBV DNA; and planned ascending dose levels with multiple dose administrations per dose level in the ongoing ELIMINATE-B clinical trial. In some cases, you can identify forward-looking statements by terms such as “aim,” “anticipate,” “approach,” “belief”, “believe,” “contemplate,” “could,” “design,” “designed,” “estimate,” “expect,” “goal,” “intend,” “look,” “may,” “mission,” “plan,” “possible,” “potential,” “predict,” “project,” “pursue,” “should,” “strive,” “suggest,” “target,” “will,” “would,” or the negative thereof and similar words and expressions.
Forward-looking statements are based on management’s current expectations, beliefs, and assumptions and on information currently available to us. These statements are neither promises nor guarantees, and involve a number of known and unknown risks, uncertainties and assumptions, and actual results may differ materially from those expressed or implied in the forward-looking statements due to various important factors, including, but not limited to, the progression and success of our programs and product candidates in which we expend our resources; our limited ability or inability to assess the safety and efficacy of our product candidates; our dependence on our ARCUS technology; the initiation, cost, timing, progress, achievement of milestones and results of research and development activities and preclinical and clinical studies, including clinical trial and investigational new drug applications; our ability to advance product candidates into, and successfully design, implement and complete, clinical trials; changes in interim “top-line” and initial data that we announce or publish; our current and future relationships with and reliance on third parties including suppliers and manufacturers; and other important factors discussed under the caption “Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2024 and our Quarterly Reports on Form 10-Q for the quarterly periods ended March 31, 2025, June 30, 2025, and September 30, 2025 as any such factors may be updated from time to time in our other filings with the U.S. Securities and Exchange Commission (SEC), which are accessible on the SEC’s website at www.sec.gov and the Investors page of our website under SEC Filings at investor.precisionbiosciences.com.
All forward-looking statements speak only as of the date of this press release and, except as required by applicable law, we have no obligation to update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise.
View source version on businesswire.com: https://www.businesswire.com/news/home/20260311909733/en/
Investor and Media Contact:
Naresh Tanna
Vice President of Investor Relations
naresh.tanna@precisionbiosciences.com
Original: Precision BioSciences Receives U.S. Patent Allowances Covering the PBGENE-HBV Program
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