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.
89Bio, Inc. (NASDAQ: ETNB) is a clinical-stage biopharmaceutical company pioneering therapies for liver and cardiometabolic diseases, with its lead candidate pegozafermin advancing through Phase 3 trials. This page serves as the authoritative source for all official company updates, including clinical developments, regulatory milestones, and strategic partnerships.
Investors and researchers will find timely updates on-therapeutic progress for metabolic dysfunction-associated steatohepatitis (MASH) and severe hypertriglyceridemia (SHTG). The curated news collection provides essential context on trial designs, scientific publications, and market developments relevant to 89Bio's glycoPEGylated FGF21 analog platform.
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89bio, Inc. (Nasdaq: ETNB) announced the initiation of the Phase 2b ENLIVEN trial for its leading drug candidate BIO89-100, targeting patients with NASH. The trial will assess safety and efficacy over 48 weeks with various dosing strategies. The company completed enrollment in the histology cohort and expects topline data by year-end 2021. Financially, 89bio reported a net loss of $20.7 million for Q2 2021, driven by increased R&D expenses totaling $15.6 million. As of June 30, 2021, the company held $171 million in cash and equivalents, positioning it strongly for ongoing clinical developments.
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.
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