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.
News for 89bio, Inc. (ETNB) centers on its role as a clinical-stage biopharmaceutical company developing therapies for liver and cardiometabolic diseases, as well as its corporate transition following its acquisition by Roche. Company press releases and SEC reports highlight pegozafermin, a fibroblast growth factor 21 (FGF21) analog engineered with glycoPEGylated technology, as its lead product candidate in Phase 3 development for metabolic dysfunction-associated steatohepatitis (MASH) with advanced fibrosis and severe hypertriglyceridemia (SHTG).
Visitors to this ETNB news page can review historical announcements about 89bio’s clinical programs, including updates on the ENLIGHTEN-Fibrosis and ENLIGHTEN-Cirrhosis Phase 3 trials in MASH and the ENTRUST Phase 3 trial in SHTG. Releases describe trial designs, planned topline data timing, and the company’s expectations regarding potential regulatory pathways, as well as operational items such as construction of a commercial-scale production facility for pegozafermin.
The news flow also covers corporate and capital markets activity. This includes inducement stock option grants under Nasdaq Listing Rule 5635(c)(4), participation in major healthcare and biopharma investor conferences, and quarterly financial updates that discuss research and development spending and general and administrative expenses in the context of advancing the Phase 3 programs.
A key development in the ETNB news record is the announcement of an Agreement and Plan of Merger with Roche Holdings, Inc., followed by the commencement and completion of a tender offer. Related communications describe the cash consideration, the structure of non-tradeable contingent value rights (CVRs) tied to pegozafermin milestones, and the subsequent delisting of ETNB from The Nasdaq Global Market as 89bio became a wholly owned subsidiary of Roche. Investors and researchers can use this page as an archive of 89bio’s historical news, from clinical milestones to the closing of the Roche transaction.
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.