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) announced the appointment of E. Morrey Atkinson, Ph.D., to its Board of Directors. Dr. Atkinson, with over 20 years of expertise in biopharmaceutical development and manufacturing, previously held senior roles at Vertex and Bristol Myers Squibb. CEO Rohan Palekar emphasized Atkinson’s valuable experience in optimizing manufacturing and commercializing therapies. This comes after promising data from the Phase 1b/2a study of 89bio's lead candidate, pegozafermin, targeting liver diseases like NASH and SHTG.
89bio, a clinical-stage biopharmaceutical company (Nasdaq: ETNB), announced its participation in the SVB Leerink 11th Annual Global Healthcare Conference on February 16, 2022, at 12:00 PM ET. The management team will engage in a fireside chat and one-on-one investor meetings. A presentation will be available via the conference portal and archived on its website.
89bio, focused on therapies for liver and cardio-metabolic diseases, announced positive results from a Phase 1b/2a study of pegozafermin for treating NASH. In an expansion cohort of 20 patients, 63% achieved a 2-point improvement in NAS without worsening fibrosis, with 32% showing NASH resolution. The treatment also showed significant changes in liver health and cardio-metabolic markers, with pegozafermin being generally well tolerated. The ongoing Phase 2b ENLIVEN trial is expected to provide further insights, with results anticipated in the first half of 2023.
89bio, Inc. (Nasdaq: ETNB) recently presented findings from the Phase 1b/2a study of BIO89-100 at The Liver Meeting 2021, revealing a significant average reduction of 11.8% in spleen volume among NASH patients. This post-hoc analysis establishes a correlation between liver fat reduction and decreased spleen volume, suggesting improved portal blood flow as a mechanism. The oral presentation was recognized by the AASLD as a key presentation at the event. With promising preliminary data, 89bio aims to further explore BIO89-100's therapeutic potential for NASH.
89bio, Inc. (Nasdaq: ETNB) reported its Q3 2021 financial results, highlighting significant advancements in its clinical program for BIO89-100, targeted at liver and cardio-metabolic diseases. The company plans to release data from its NASH study in January 2022 and from its SHTG study in the first half of 2022. As of September 30, 2021, 89bio had $157.4 million in cash but reported a net loss of $28.3 million for Q3 2021, an increase from the previous year, mainly due to rising R&D and G&A expenses.
89bio, Inc. (Nasdaq: ETNB) has appointed Kathy LaPorte to its Board of Directors, effective immediately. LaPorte brings over 30 years of biotech industry experience, enhancing operational capabilities and driving growth. CEO Rohan Palekar praised her expertise as invaluable for advancing the ongoing clinical development of BIO89-100, a potential treatment for NASH. LaPorte's background includes leadership roles in various biotech boards and a strong record in venture investing.
This strategic appointment aims to bolster 89bio's efforts in developing innovative therapies for liver and cardio-metabolic diseases.
89bio, Inc. (ETNB) announced new findings from a sub-analysis of its Phase 1b/2a study on BIO89-100 for non-alcoholic steatohepatitis (NASH), revealing a correlation between increased liver fat and spleen volume. The results will be presented at the AASLD The Liver Meeting 2021, taking place virtually from November 12-15, 2021. Additionally, the population pharmacokinetics and pharmacodynamics of BIO89-100 will be showcased. This treatment is engineered to enhance the biological activity of FGF21, aimed at addressing the root causes of NASH and severe hypertriglyceridemia.
89bio, Inc. (Nasdaq: ETNB), a clinical-stage biopharmaceutical company, announced a corporate update and one-on-one investor meetings at the Cantor Global Healthcare Conference on September 28, 2021, at 2:40 p.m. ET. The event will be virtual, and the presentation can be accessed via the investor section of 89bio's website. The company focuses on innovative therapies for liver and cardio-metabolic diseases, with its lead candidate BIO89-100 targeting nonalcoholic steatohepatitis (NASH) and severe hypertriglyceridemia (SHTG).
89bio, Inc. (Nasdaq: ETNB) announced its participation in the H.C. Wainwright 23rd Annual Global Investment Conference from September 13-15, 2021. The presentation will be available on-demand starting September 13 at 7:00 a.m. ET via the H.C. Wainwright conference portal. An archived webcast will be accessible on 89bio’s website. 89bio focuses on innovative therapies for liver and cardio-metabolic diseases, with its lead product candidate, BIO89-100, targeting nonalcoholic steatohepatitis and severe hypertriglyceridemia.
89bio, Inc. (Nasdaq: ETNB) announced the initiation of the Phase 2b ENLIVEN trial for its leading drug candidate BIO89-100, targeting patients with NASH. The trial will assess safety and efficacy over 48 weeks with various dosing strategies. The company completed enrollment in the histology cohort and expects topline data by year-end 2021. Financially, 89bio reported a net loss of $20.7 million for Q2 2021, driven by increased R&D expenses totaling $15.6 million. As of June 30, 2021, the company held $171 million in cash and equivalents, positioning it strongly for ongoing clinical developments.
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