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, a clinical-stage biopharmaceutical company, announced participation in the virtual H.C. Wainwright Global Life Sciences Conference on March 9-10, 2021. The presentation will be available on-demand starting at 7 a.m. EST on March 9, with an archived webcast accessible on 89bio’s website. The company focuses on innovative therapies for liver and cardio-metabolic diseases, notably their lead candidate BIO89-100, targeting nonalcoholic steatohepatitis (NASH) and severe hypertriglyceridemia (SHTG). 89bio is based in San Francisco.
89bio, a clinical-stage biopharmaceutical company, announced it will provide a corporate update and engage in one-on-one investor meetings at the Raymond James 42nd Annual Institutional Investors Conference on March 3, 2021, at 12:30 PM ET. The presentation will be accessible via the conference portal. 89bio focuses on therapies for liver and cardio-metabolic diseases, with its lead product BIO89-100 targeting NASH and severe hypertriglyceridemia.
89bio, a clinical-stage biopharmaceutical company specializing in treatments for liver and cardio-metabolic diseases, announced a corporate update at the SVB Leerink 10th Annual Global Healthcare Conference on February 25, 2021, at 5:00 PM ET. The event will feature one-on-one investor meetings and a presentation accessible via the conference portal. The company's lead candidate, BIO89-100, targets nonalcoholic steatohepatitis (NASH) and severe hypertriglyceridemia (SHTG). For more details, the webcast will be archived on 89bio’s investor section.
89bio, Inc. (Nasdaq: ETNB) announced significant advancements in its clinical development program for BIO89-100, targeted at liver and cardio-metabolic diseases. The company is set to initiate a Phase 2b NASH trial in 1H21 and expects topline data from the open-label histology cohort by year-end 2021. The Phase 2 SHTG trial is also underway, with results anticipated in 2H21. Encouraging data from a previous Phase 1b/2a trial indicated reductions in liver fat of up to 70% and significant improvements in ALT and triglycerides, showcasing the positive risk-benefit profile of BIO89-100.
89bio, Inc. (Nasdaq: ETNB), a clinical-stage biopharmaceutical company focused on innovative therapies for liver and cardio-metabolic diseases, will present a corporate update at the virtual H.C. Wainwright BioConnect 2021 Conference from January 11-14, 2021. CEO Rohan Palekar's presentation will be available on-demand starting at 6 a.m. EST on January 11. The archived webcast can be accessed in the investor section of 89bio’s website. The company’s lead product, BIO89-100, targets nonalcoholic steatohepatitis (NASH) and severe hypertriglyceridemia (SHTG).
89bio, Inc (Nasdaq: ETNB), a clinical-stage biopharmaceutical company, will have its CEO, Rohan Palekar, participate in investor meetings at the Piper Sandler 32nd Annual Virtual Healthcare Conference on December 2, 2020. The conference runs from December 1-3, 2020. An archived webcast of the discussion will be available on 89bio’s website.
89bio is focused on therapies for liver and cardio-metabolic diseases, with its lead candidate, BIO89-100, aimed at treating nonalcoholic steatohepatitis (NASH) and severe hypertriglyceridemia (SHTG).
89bio, Inc. (Nasdaq: ETNB) announced updated positive data from its Phase 1b/2a study of BIO89-100, a treatment for nonalcoholic steatohepatitis (NASH). The study demonstrates significant reductions in liver fat, ALT levels, and triglycerides across various dosing groups with favorable tolerability. Notably, 88% of patients achieved a ≥30% reduction in liver fat. The company plans to initiate a Phase 2b study in early 2021, emphasizing its commitment to addressing NASH's unmet medical needs.
89bio, Inc. (Nasdaq: ETNB) announced significant advancements in its clinical development program during Q3 2020. Positive results from the Phase 1b/2a trial of BIO89-100 for NASH highlighted a 70% liver fat reduction and excellent tolerability. The company is set to present data at the AASLD Liver Meeting and initiate a Phase 2b trial in NASH in H1 2021. Financially, 89bio reported a net loss of $14.6 million, improving from $18.7 million year-over-year, with cash reserves at $219.2 million, supporting ongoing research initiatives.
89bio, Inc. (Nasdaq: ETNB) announced the presentation of promising clinical data for its drug BIO89-100 targeted at treating nonalcoholic steatohepatitis (NASH) during The Liver Meeting Digital Experience™ 2020 from November 13-16. Results from a Phase 1b/2a study revealed significant reductions in liver fat via MRI-PDFF, with favorable safety and tolerability profiles, suggesting potential best-in-class dosing. The study demonstrated robust efficacy with both weekly and biweekly dosing, highlighting the drug's potential as a treatment in a field lacking approved options.
89bio, a clinical-stage biopharmaceutical company focused on liver and cardio-metabolic diseases, announced that CEO Rohan Palekar will present at the H.C. Wainwright 4th Annual NASH Investor Conference on October 5, 2020, at 11:30 AM ET. The presentation will be available via live and archived webcast on the company’s website. 89bio's lead product, BIO89-100, targets nonalcoholic steatohepatitis (NASH) and severe hypertriglyceridemia (SHTG). The company is headquartered in San Francisco with operations in Herzliya, Israel.
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