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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 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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