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Get filing alertsPrecision BioSciences reports positive Phase 1 hepatitis B trial data showing viral DNA elimination
Filed May 27, 2026 · Period ending May 27, 2026 · ~1 min read
Key Changes
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PBGENE-HBV achieved 10-fold reduction in viral DNA transcripts by directly eliminating cccDNA, the persistent form of hepatitis B virus in liver cells, demonstrating the drug's mechanism works in humans.
Item 7.01: Press Release verify on EDGAR → -
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All six patients with measurable pgRNA at baseline achieved complete elimination of this biomarker, validating a blood test that can replace invasive liver biopsies to measure treatment effectiveness in future trials.
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No dose-limiting toxicities observed across 38 doses in 16 patients; most side effects were temporary infusion reactions resolving within 24 hours.
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One patient at highest dose (0.8 mg/kg) experienced two serious adverse events including treatment-related low blood pressure after second dose; patient recovered and is stable at home.
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After implementing safety measures (slower infusion, higher steroids), 20% of doses delivered under new protocol with no severe hypotension or liver enzyme elevations observed.
Item 7.01: Safety Mitigation verify on EDGAR →
Summary
Precision BioSciences disclosed encouraging Phase 1 trial results for PBGENE-HBV, its experimental treatment for chronic hepatitis B. The data, presented at a major liver disease conference in Barcelona, showed the therapy achieved its primary goal: a 10-fold reduction in viral DNA by directly eliminating cccDNA, the persistent reservoir that makes hepatitis B so difficult to cure.
Importantly, all treated patients showed complete clearance of a key biomarker in blood tests that correlated perfectly with liver tissue results, potentially eliminating the need for invasive biopsies in future studies. The safety profile was generally manageable, with most side effects being temporary infusion reactions.
However, one patient at the highest dose experienced serious low blood pressure events, prompting the company to implement mitigation measures including slower infusions and higher steroid doses. Since these changes, no severe safety events have occurred in the 20% of doses administered under the new protocol. Retail investors should watch for updates on dose expansion and whether the company can maintain efficacy while avoiding serious adverse events as enrollment continues. The validation of a blood-based biomarker could significantly accelerate and reduce costs for future development if the therapy advances.
Section-by-Section Diff
Event · Item 7.01 — Regulation FD Disclosure
Precision BioSciences disclosed new clinical and biopsy data from its Phase 1 ELIMINATE-B trial in chronic hepatitis B at EASL Congress 2026.
Added in current filing · view on EDGAR → · paraphrased
the Company will host an investor webcast on May 27, 2026 at 8:00 a.m., Eastern Time to discuss new biopsy and clinical data from the ongoing Phase 1 ELIMINATE-B trial in chronic hepatitis B. The presentation will include new clinical data along with late-breaker biopsy data featured at the European Association for the Study of the Liver ("EASL") Congress 2026 on May 27, 2026, in Barcelona, Spain.
The company announced it would present new clinical and biopsy data from its ongoing Phase 1 trial evaluating PBGENE-HBV for chronic hepatitis B treatment. The data includes late-breaking biopsy results featured at a major liver disease conference. This disclosure provides investors visibility into the progress of a key clinical program.
Added in current filing · verify on EDGAR →
the Company issued a press release to announce new and late-breaking PBGENE-HBV clinical data from the ELIMINATE-B study at EASL.
The company issued a press release announcing new clinical data for its PBGENE-HBV candidate from the ELIMINATE-B study. This formal announcement disseminates material clinical trial results to the investment community and broader stakeholders.
Event · Item 8.01 — Other Events
Precision BioSciences announced positive PBGENE-HBV clinical trial data showing cccDNA elimination and manageable safety profile.
Added in current filing · verify on EDGAR →
As of data cutoff, 38 doses have been administered across 16 patients in 5 cohorts for the safety analysis. No dose limiting toxicities were observed. The most common adverse events include infusion-related reactions consistent with lipid nanoparticle (“LNP”) effects, with onset and resolution within 24 hours of infusion.
Across 38 doses given to 16 patients, no toxicities severe enough to halt dose escalation were observed. Most side effects were temporary infusion reactions lasting under 24 hours, consistent with the lipid nanoparticle delivery system used.
Added in current filing · verify on EDGAR →
Grade 3 hypotension was observed during dose escalation, and one patient in the highest dose cohort (0.8 mg/kg) experienced two serious adverse events (“SAEs”) after the second LNP administration. One of the events was deemed treatment related and mechanistically related to hypotension. The patient is ambulatory, home, and stable.
One patient at the highest dose level experienced two serious adverse events after their second treatment, with one event related to low blood pressure caused by the treatment. The patient has recovered and is stable at home. The company states they now understand the cause and have implemented mitigation measures including slower infusion rates and higher steroid doses.
Added in current filing · verify on EDGAR →
Up to 20% of the doses delivered in the ELIMINATE-B trial have now been administered under the mitigation protocol and no ≥ Grade 3 hypotension events or ≥ Grade 3 LNP-related ALT/AST lab abnormalities have been observed since the implementation.
After implementing safety measures (slower infusion, increased steroids), approximately 20% of trial doses have been given under the new protocol with no severe low blood pressure events or severe liver enzyme elevations observed. This suggests the safety issues identified earlier have been successfully managed.
Event · Item 9.01 — Financial Statements and Exhibits
Precision BioSciences filed an 8-K attaching a press release dated May 27, 2026; no material event details disclosed in the filing body.
Added in current filing · verify on EDGAR →
Press release of Precision BioSciences, Inc. dated May 27, 2026.
The 8-K references an attached press release dated May 27, 2026, but the filing body does not disclose the content or subject matter of the press release. Without the exhibit text, the nature and materiality of the announcement cannot be determined from this filing alone.
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Figures/quotes linked to EDGAR · Narrative written by AI · May 27, 2026 · How we verify