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.
About 89bio, Inc.
89bio, Inc. (Nasdaq: ETNB) is a clinical-stage biopharmaceutical company headquartered in San Francisco, California, dedicated to the development and commercialization of innovative therapies for liver and cardiometabolic diseases. The company’s mission is to address unmet medical needs in these areas by advancing its lead product candidate, pegozafermin, a glycoPEGylated analog of fibroblast growth factor 21 (FGF21). Pegozafermin is specifically engineered to optimize biological activity through an extended half-life, making it a promising therapeutic option for complex conditions such as metabolic dysfunction-associated steatohepatitis (MASH)—formerly known as nonalcoholic steatohepatitis (NASH)—and severe hypertriglyceridemia (SHTG).
Core Focus and Product Pipeline
The company’s primary focus is on developing pegozafermin for the treatment of MASH, a chronic and progressive liver disease characterized by fat accumulation, inflammation, and fibrosis, which can lead to cirrhosis, liver failure, or hepatocellular carcinoma. Pegozafermin is also being developed for SHTG, a condition marked by dangerously high triglyceride levels that increase the risk of pancreatitis and cardiovascular disease. Both indications represent significant unmet medical needs, with limited treatment options available.
Pegozafermin has demonstrated encouraging results in clinical trials, showing potential anti-fibrotic, anti-inflammatory, and metabolic benefits. The company is currently advancing pegozafermin through multiple Phase 3 clinical trials under its ENLIGHTEN and ENTRUST programs. These trials aim to evaluate the efficacy and safety of pegozafermin in both non-cirrhotic and cirrhotic MASH patients, as well as in individuals with SHTG. The company’s clinical strategy is bolstered by regulatory designations such as Breakthrough Therapy status from the U.S. FDA and PRIME designation from the European Medicines Agency (EMA), which underscore the potential of pegozafermin to address critical unmet needs.
Competitive Positioning
89bio operates in a competitive biopharmaceutical landscape, with other companies also pursuing therapies for NASH/MASH and SHTG. However, the company differentiates itself through its proprietary glycoPEGylation technology, which enhances the pharmacokinetics and therapeutic potential of pegozafermin. Clinical data from the Phase 2b ENLIVEN trial demonstrated statistically significant improvements in liver histology, non-invasive biomarkers, and metabolic parameters, positioning pegozafermin as a potentially best-in-class FGF21 analog.
Challenges and Opportunities
Like other clinical-stage biopharmaceutical companies, 89bio faces challenges such as clinical trial risks, regulatory approval processes, and the need for substantial capital to fund its development programs. The competitive landscape for MASH and SHTG therapies also necessitates differentiation through clinical efficacy, safety, and patient convenience. Nonetheless, the company’s robust clinical pipeline, strategic focus on high-need indications, and strong regulatory support provide a solid foundation for potential success.
Conclusion
89bio, Inc. is at the forefront of developing transformative therapies for liver and cardiometabolic diseases. By leveraging its expertise in FGF21 biology and glycoPEGylation technology, the company aims to deliver innovative solutions for patients with MASH and SHTG, addressing significant gaps in current treatment paradigms. With its lead candidate pegozafermin progressing through late-stage clinical trials, 89bio is well-positioned to make a meaningful impact in the biopharmaceutical industry.
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.
FAQ
What is the current stock price of 89Bio (ETNB)?
What is the market cap of 89Bio (ETNB)?
What is 89bio's primary focus?
What is pegozafermin?
What differentiates 89bio from competitors?
What clinical trials is 89bio currently conducting?
What regulatory designations has pegozafermin received?
What are the key benefits of pegozafermin?
What challenges does 89bio face?
Where is 89bio headquartered?
What is the significance of glycoPEGylation technology?
What is MASH, and why is it significant?
