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) has announced the pricing of its public offering of 16,923,077 shares of common stock at $16.25 per share, which will raise approximately $275 million in gross proceeds. The offering includes a 30-day option for underwriters to purchase an additional 2,538,461 shares. The offering is expected to close around March 28, 2023, subject to customary conditions. BofA Securities, SVB Securities, and Evercore ISI are acting as lead book-running managers. 89bio focuses on innovative therapies for liver and cardio-metabolic diseases, with its lead candidate targeting non-alcoholic steatohepatitis (NASH).
89bio, a clinical-stage biopharmaceutical company (Nasdaq: ETNB), announced a public offering of $200 million in common stock or pre-funded warrants. The offering includes a 30-day option for underwriters to purchase an additional $30 million. Proceeds will support clinical activities for pegozafermin, focusing on liver and cardio-metabolic diseases. The offering is subject to market conditions. BofA Securities, SVB Securities, and Evercore ISI are the book-running managers. The company emphasizes that this press release is not an offer to sell securities, as per SEC regulations.
89bio, Inc. (ETNB) announced positive results from its Phase 2b ENLIVEN trial of pegozafermin in patients with nonalcoholic steatohepatitis (NASH). The trial demonstrated statistically significant improvements in fibrosis and NASH resolution, with the 44mg Q2W and 30mg QW doses achieving placebo-adjusted effect sizes of 20% and 19% for fibrosis improvement, and 24% and 21% for NASH resolution, respectively. The study's results support progression to Phase 3 trials, highlighting pegozafermin’s potential as a differentiated treatment for NASH. The company’s rigorous methodology adds credibility to the findings.
89bio, a clinical-stage biopharmaceutical company, reported significant advancements in its late-stage development program for pegozafermin. Key updates include topline results from the ENLIVEN Phase 2b trial for NASH, anticipated in Q1 2023, and FDA feedback supporting a Phase 3 program for severe hypertriglyceridemia (SHTG), with trials set to begin in Q2 2023. Financially, the company held $188.2 million in cash as of December 31, 2022, a rise from $150.7 million in 2021. However, net losses increased to $102 million for the year, driven by higher R&D and G&A expenses.
89bio, a clinical-stage biopharmaceutical company, presented additional findings from the Phase 2 ENTRIGUE trial at ACC.23/WCC, demonstrating that pegozafermin significantly reduced triglycerides and atherogenic lipids in patients with severe hypertriglyceridemia (SHTG).
The study involved 85 participants, showing a 62% reduction in triglycerides for patients not on background therapy and 68% for those on lipid-modifying therapy, compared to placebo. The overall success of pegozafermin supports advancing to a Phase 3 trial. This treatment is expected to offer new therapeutic options for SHTG, which affects millions in the U.S., presenting a compelling profile for cardiovascular risk reduction.
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