Welcome to our dedicated page for 89Bio news (Ticker: ETNB), a resource for investors and traders seeking the latest updates and insights on 89Bio stock.
Overview
89Bio, Inc. (symbol: ETNB) is a United States-based clinical-stage biopharmaceutical company committed to advancing innovative therapies for patients with liver and cardiometabolic diseases. Employing cutting-edge glycoPEGylation technology, the company is focused on enhancing the biological activity and prolonging the half-life of its therapeutic candidates through advanced drug engineering. With a robust pipeline centered on conditions such as metabolic dysfunction-associated steatohepatitis (MASH) and severe hypertriglyceridemia (SHTG), 89Bio is addressing significant unmet clinical needs with precision and scientific rigor.
Core Business and Product Pipeline
The company’s primary focus is on the development and eventual commercialization of pegozafermin, a specifically engineered fibroblast growth factor 21 (FGF21) analog. This molecule, enhanced by unique glycoPEGylated technology, has been designed to exert potent anti-fibrotic and metabolic effects. It aims to treat advanced liver conditions by reducing fibrosis and ameliorating metabolic dysregulation, a dual approach that positions 89Bio uniquely in the biotech landscape. Beyond its lead candidate, the company continues to explore additional therapeutic avenues within the liver and cardiometabolic realms, ensuring a diversified approach to clinical development.
Clinical Development and Research
89Bio has structured its clinical research around rigorous Phase 3 trials, notably the ENLIGHTEN program, which encompasses pivotal studies in both non-cirrhotic MASH (with fibrosis stages F2-F3) and MASH with compensated cirrhosis (F4). These randomized, double-blind, placebo-controlled trials are designed to evaluate key endpoints such as histological improvements in liver fibrosis and resolution of steatohepatitis. By integrating noninvasive diagnostic tools alongside traditional biopsy assessments, the company aims to streamline patient evaluation and enhance the sensitivity of therapeutic response measurement. Moreover, the advanced design of these trials reflects 89Bio's commitment to scientific excellence and clear regulatory communication, as evidenced by recent supportive designations from global regulatory bodies.
89bio, Inc. (Nasdaq: ETNB), a biopharmaceutical company, announced new data from its Phase 2 ENTRIGUE study on pegozafermin for treating severe hypertriglyceridemia (SHTG). The findings will be showcased at the American College of Cardiology's 72nd Annual Scientific Session in New Orleans from March 4-6, 2023. The study, titled 'Pegozafermin Provides Beneficial Lipid Effects in Subjects with Severe Hypertriglyceridemia,' indicates that the treatment could yield significant lipid benefits, regardless of patients' background lipid-modifying therapy. The poster presentation is scheduled for March 4, 2023.
89bio, Inc. (Nasdaq: ETNB), a clinical-stage biopharmaceutical company, announced participation in the SVB Securities Global Biopharma Conference on February 15, 2023, at 12:00 PM ET. Management will engage in a fireside chat and hold one-on-one investor meetings. The event will be available for viewing via a webcast, accessible on their website. 89bio is focused on developing innovative therapies for liver and cardio-metabolic diseases, rapidly advancing its lead candidate, pegozafermin, aimed at treating non-alcoholic steatohepatitis (NASH) and severe hypertriglyceridemia (SHTG). The company is headquartered in San Francisco.
89bio, a clinical-stage biopharmaceutical company, reported significant advancements in its clinical programs for pegozafermin. The company expects topline data from the ENLIVEN Phase 2b NASH trial in Q1 2023 and plans to initiate a Phase 3 trial for severe hypertriglyceridemia (SHTG) in H1 2023, following FDA feedback. Additionally, 89bio secured a $100 million credit facility from K2 HealthVentures, enhancing its financial position with pro forma cash of $188.4 million as of December 31, 2022. These steps signal a positive trajectory for the company's ongoing development of therapies targeting liver and cardio-metabolic diseases.
89bio, a clinical-stage biopharmaceutical company, announced positive results from its Phase 1b/2a study of pegozafermin for treating nonalcoholic steatohepatitis (NASH). Data published in The Lancet Gastroenterology & Hepatology revealed that up to 88% of patients showed a significant reduction in hepatic fat fraction. The treatment was well-tolerated with no severe adverse events, indicating its potential as a leading therapy for NASH. The company is advancing to the Phase 2b ENLIVEN trial, with topline results expected in Q1 2023.
89bio, Inc. (Nasdaq: ETNB) recently reported its Q3 2022 financial results, highlighting completion of enrollment in the Phase 2b ENLIVEN trial for NASH, with topline data expected in Q1 2023. The company also presented encouraging data from its Phase 1b/2a NASH study and the ENTRIGUE Phase 2 trial at major conferences. As of September 30, 2022, 89bio had cash and equivalents of $193.3 million, reporting a net loss of $26.8 million for Q3 2022. The firm anticipates initiating a Phase 3 trial for severe hypertriglyceridemia patients in the first half of 2023.
89bio, Inc. (Nasdaq: ETNB) presented new data from the Phase 1b/2a study on pegozafermin for treating nonalcoholic steatohepatitis (NASH) at the AASLD Liver Meeting 2022. In a post-hoc analysis of cohort 7, it was found that excluding patients with fibrosis stage 4 (F4) improved histological response rates. Out of 19 patients, 6 were identified as F4. Key findings included a 77% response rate for ≥ 2 point reduction in NAS after excluding F4 patients. The company aims to report topline data from the Phase 2b ENLIVEN trial in Q1 2023, further evaluating pegozafermin's efficacy.
89bio, a clinical-stage biopharmaceutical company focusing on therapies for liver and cardio-metabolic diseases, will participate in the H.C. Wainwright 6th Annual NASH Investor Conference on October 17, 2022, at 11:30 AM ET.
Management will engage in a fireside chat and one-on-one investor meetings. The presentation will be available via webcast, accessible here.
89bio, Inc. (Nasdaq: ETNB), a clinical-stage biopharmaceutical company, will participate in the H.C. Wainwright 24th Annual Global Investment Conference on September 12, 2022, at 4:00 PM ET. The event includes a fireside chat and one-on-one investor meetings, accessible via webcast on the company's website. 89bio is focused on developing innovative therapies for liver and cardiometabolic diseases, particularly its lead candidate, pegozafermin, aimed at treating non-alcoholic steatohepatitis (NASH) and severe hypertriglyceridemia (SHTG).
89bio, Inc. (Nasdaq: ETNB) presented positive results from the ENTRIGUE Phase 2 trial of pegozafermin for severe hypertriglyceridemia (SHTG) at the ESC Congress 2022. The treatment significantly reduced triglycerides (TG) across all doses, achieving median reductions of up to 63% compared to a 12% reduction in the placebo group. Pegozafermin also improved liver fat and glycemic control. The findings support advancing into a Phase 3 trial anticipated in the first half of 2023, indicating potential for pegozafermin as a key treatment for cardio-metabolic and liver diseases.
89bio, Inc. (Nasdaq: ETNB) has successfully completed enrollment in its Phase 2b ENLIVEN trial of pegozafermin, targeting non-alcoholic steatohepatitis (NASH). A total of 219 patients have been enrolled to receive either active treatment or placebo. Topline data is anticipated in the first quarter of 2023. The trial aims to evaluate the drug's efficacy and safety profile, building on previous positive results. The pegozafermin candidate utilizes innovative technology to enhance its therapeutic potential for patients suffering from liver diseases.
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