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, Inc. (Nasdaq: ETNB) reported its Q1 2024 financial results, highlighting the initiation of Phase 3 trials for pegozafermin in MASH patients, EMA's PRIME status, and positive data from the ENLIVEN Phase 2b Trial. The company also entered a collaboration agreement for commercial supply and appointed a new Board member. Financially, 89bio had $562.3 million in cash, R&D expenses increased to $47.4 million, G&A expenses rose to $9.8 million, resulting in a net loss of $51.7 million.
89bio, Inc. (Nasdaq: ETNB) will participate in the BofA Securities 2024 Health Care Conference to present their innovative therapies for liver and cardiometabolic diseases. The presentation is scheduled for May 15, 2024, at 2:20 PM PDT.
89bio, Inc. (Nasdaq: ETNB) will host a key opinion leader event discussing pegozafermin's potential in advanced metabolic dysfunction-associated steatohepatitis (MASH) on May 16, 2024, featuring expert hepatologist Arun Sanyal, M.D. The webinar will cover the ENLIGHTEN-Cirrhosis trial and the commercial prospects for pegozafermin in advanced MASH.
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