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89bio, Inc. (Nasdaq: ETNB) is a clinical-stage biopharmaceutical company headquartered in San Francisco, California. Since its founding in 2018, 89bio has been committed to developing and commercializing innovative therapies for the treatment of liver and cardio-metabolic diseases, addressing critical unmet medical needs.
The company’s lead product candidate is pegozafermin (formerly BIO89-100), a specifically engineered glycoPEGylated analog of fibroblast growth factor 21 (FGF21). Pegozafermin has shown promise in treating nonalcoholic steatohepatitis (NASH) and severe hypertriglyceridemia (SHTG). This candidate targets metabolic dysfunction-associated steatohepatitis (MASH), which can lead to severe liver complications, including cirrhosis and liver failure.
89bio is actively advancing pegozafermin through various phases of clinical trials. Recently, the company announced a successful end-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA), allowing them to proceed to Phase 3 trials. Two Phase 3 trials, ENLIGHTEN-Cirrhosis and ENLIGHTEN-Fibrosis, are set to enroll patients in 2024. The ENLIGHTEN program aims to evaluate the efficacy and safety of pegozafermin in patients with different stages of liver fibrosis.
Pegozafermin has demonstrated strong anti-fibrotic and anti-inflammatory properties in the liver, as well as improved lipid metabolism, insulin resistance, and glycemic control. It has received Breakthrough Therapy designation from the FDA and Priority Medicines (PRIME) status from the European Medicines Agency (EMA), emphasizing its therapeutic potential and the urgency for such treatments.
Financially, 89bio reported substantial cash reserves, ensuring robust support for ongoing clinical activities. As of December 31, 2023, the company had $578.9 million in cash and equivalents. This strong financial position enables continued development and potential scaling up for commercial production.
89bio maintains strategic partnerships to bolster its clinical and commercialization efforts. These collaborations are crucial as the company aims to bring pegozafermin to market, providing solutions for patients with liver and cardio-metabolic diseases who lack effective treatment options.
For more detailed updates, recent financial results, and upcoming milestones, visit their official website or follow their LinkedIn profile.
89bio, Inc. (Nasdaq: ETNB) announced its Q4 and full-year 2020 results, showcasing a robust cash position of $204.7 million, up from $93.4 million in 2019. Research and Development (R&D) expenses increased to $36.2 million as the company advances its lead candidate, BIO89-100, into a Phase 2b trial for NASH this year. Positive data from Phase 1b/2a trials highlights BIO89-100's efficacy in reducing liver fat, with anticipated topline data from NASH and SHTG trials expected in late 2021, marking significant progress in its clinical pipeline.
89bio, Inc. (Nasdaq: ETNB) announced promising results from its Phase 1b/2a study of BIO89-100, a treatment for nonalcoholic steatohepatitis (NASH). Data revealed up to 15% reduction in liver volume and 65% reduction in liver fat volume over 13 weeks. The favorable safety profile showed side effects comparable to placebo. The findings will be presented at ENDO 2021, emphasizing the potential of BIO89-100 for NASH and severe hypertriglyceridemia. NASH affects over 16 million adults in the U.S., with growing prevalence expected by 2030.
89bio, a clinical-stage biopharmaceutical company (Nasdaq: ETNB), announced its participation in the Oppenheimer 31st Annual Healthcare Conference on March 17, 2021, at 1:10 p.m. ET. The event will be virtual, and the presentation can be accessed via the Oppenheimer conference portal, with an archived version available on 89bio’s investor website. The company focuses on innovative therapies for liver and cardio-metabolic diseases, with its leading product candidate, BIO89-100, targeting nonalcoholic steatohepatitis (NASH) and severe hypertriglyceridemia (SHTG).
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.
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