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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, a clinical-stage biopharmaceutical company, will present 48-week data from its Phase 2b ENLIVEN trial evaluating pegozafermin in patients with metabolic dysfunction-associated steatohepatitis (MASH) at the EASL International Liver Congress in Milan, Italy, from June 5 to 8, 2024. The data highlights pegozafermin as the first FGF21 analog showing positive, sustained benefits over 48 weeks in patients with advanced MASH. The presentation will cover the drug's efficacy, tolerability, and improvements in liver health markers, and will be delivered by Dr. Rohit Loomba on June 8.
89bio has initiated the Phase 3 ENLIGHTEN-Cirrhosis trial for pegozafermin in patients with MASH and compensated cirrhosis (F4). This is the first FGF21 analog to reach this trial stage for this patient subset. The trial will involve 760 patients, assessing fibrosis regression at 24 months, potentially supporting accelerated approval in the U.S. and Europe. The trial's primary goal is to observe clinical outcome events for confirmatory or full approval. The ENLIGHTEN-Cirrhosis trial builds on promising Phase 2b results showing improvements in liver health markers, aiming to meet the urgent need for effective therapies in MASH with compensated cirrhosis.
89bio, Inc. announced the approval of non-qualified stock options for four new employees under the 2023 Inducement Plan. The options allow the purchase of 48,150 shares of the Company's common stock at the closing price on May 6, 2024. The options will vest over a four-year period, contingent on continued employment.
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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