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.
Overview
89Bio, Inc. (symbol: ETNB) is a United States-based clinical-stage biopharmaceutical company committed to advancing innovative therapies for patients with liver and cardiometabolic diseases. Employing cutting-edge glycoPEGylation technology, the company is focused on enhancing the biological activity and prolonging the half-life of its therapeutic candidates through advanced drug engineering. With a robust pipeline centered on conditions such as metabolic dysfunction-associated steatohepatitis (MASH) and severe hypertriglyceridemia (SHTG), 89Bio is addressing significant unmet clinical needs with precision and scientific rigor.
Core Business and Product Pipeline
The company’s primary focus is on the development and eventual commercialization of pegozafermin, a specifically engineered fibroblast growth factor 21 (FGF21) analog. This molecule, enhanced by unique glycoPEGylated technology, has been designed to exert potent anti-fibrotic and metabolic effects. It aims to treat advanced liver conditions by reducing fibrosis and ameliorating metabolic dysregulation, a dual approach that positions 89Bio uniquely in the biotech landscape. Beyond its lead candidate, the company continues to explore additional therapeutic avenues within the liver and cardiometabolic realms, ensuring a diversified approach to clinical development.
Clinical Development and Research
89Bio has structured its clinical research around rigorous Phase 3 trials, notably the ENLIGHTEN program, which encompasses pivotal studies in both non-cirrhotic MASH (with fibrosis stages F2-F3) and MASH with compensated cirrhosis (F4). These randomized, double-blind, placebo-controlled trials are designed to evaluate key endpoints such as histological improvements in liver fibrosis and resolution of steatohepatitis. By integrating noninvasive diagnostic tools alongside traditional biopsy assessments, the company aims to streamline patient evaluation and enhance the sensitivity of therapeutic response measurement. Moreover, the advanced design of these trials reflects 89Bio's commitment to scientific excellence and clear regulatory communication, as evidenced by recent supportive designations from global regulatory bodies.
89bio, a clinical-stage biopharmaceutical company focused on liver and cardio-metabolic diseases, announced its participation in upcoming investor conferences in August 2021. The events include the BTIG Virtual Biotechnology Conference on August 9, 2021, featuring a fireside chat and one-on-one meetings, and the Canaccord Genuity 41st Annual Growth Conference on August 11, 2021. The company is developing BIO89-100, an innovative therapy for nonalcoholic steatohepatitis and severe hypertriglyceridemia. For more information, investors may contact Ryan Martins, CFO.
89bio, Inc. (Nasdaq: ETNB) announced the completion of patient enrollment for its BIO89-100 clinical trial focused on NASH (nonalcoholic steatohepatitis). This milestone involves a paired-biopsy, open-label histology cohort with 20 F2-F3 fibrosis stage patients. Key efficacy endpoints include improvements in the NAFLD Activity Score and fibrosis. Results are anticipated by year-end 2021, aiming to validate BIO89-100's therapeutic potential.
89bio, a clinical-stage biopharmaceutical company focusing on innovative therapies for liver and cardio-metabolic diseases, has announced its participation in several investor conferences this June.
- SVB Leerink CybeRx Series: Liver Disease Day - One-on-one meetings on June 17, 2021.
- Raymond James Human Health Innovation Conference - Panel discussion on NASH on June 23, 2021, at 12:00 PM ET.
- Piper Sandler EASL Takeaway Day - One-on-one meetings on June 28, 2021.
The company’s leading product candidate is BIO89-100, targeting NASH and severe hypertriglyceridemia.
89bio, Inc. (Nasdaq: ETNB) has initiated the ENLIVEN Phase 2b trial to evaluate its lead product, BIO89-100, for treating patients with fibrosis stage 2 or 3 non-alcoholic steatohepatitis (NASH). The trial will involve 216 patients and will assess the drug's efficacy in NASH resolution and fibrosis improvement over 24 weeks. Positive data from previous trials have bolstered expectations for BIO89-100's safety and dosing convenience. A distinguished steering committee of NASH experts will guide the trial, marking a significant advancement in 89bio's clinical development program.
89bio reported its Q1 2021 financial results, highlighting key developments in its clinical programs. The company received FDA guidance for its Phase 2b ENLIVEN trial for NASH, set to begin in 2Q21, targeting approximately 200 patients. Notable financials include cash holdings of $189.6 million, R&D expenses rising to $10.1 million, and a net loss of $14.8 million. The increase in net loss reflects higher R&D and G&A costs. Upcoming milestones include topline data from NASH and severe hypertriglyceridemia trials expected by year-end 2021.
89bio, a clinical-stage biopharmaceutical company listed on Nasdaq under the symbol ETNB, announced a corporate update and participation in investor meetings at two major healthcare conferences. The BofA Securities 2021 Health Care Conference is scheduled for May 13, 2021, at 1:15 PM ET, followed by the RBC Capital Markets 2021 Global Healthcare Conference on May 19, 2021, at 9:45 AM ET. Interested parties can access a live and archived webcast of the presentations on the company's website.
89bio has received written guidance from the FDA regarding its Phase 2b ENLIVEN trial for BIO89-100, aimed at treating patients with fibrosis stage 2 or 3 non-alcoholic steatohepatitis (NASH). The FDA has approved the use of a liquid formulation for this trial. The ENLIVEN trial is set to commence in Q2 2021 and will involve around 200 patients, assessing the drug's safety and efficacy over 48 weeks. The primary efficacy endpoints include NASH resolution and fibrosis improvement without worsening. Leadership expresses confidence in the program's potential.
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).
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