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, a clinical-stage biopharmaceutical company, presented additional findings from the Phase 2 ENTRIGUE trial at ACC.23/WCC, demonstrating that pegozafermin significantly reduced triglycerides and atherogenic lipids in patients with severe hypertriglyceridemia (SHTG).
The study involved 85 participants, showing a 62% reduction in triglycerides for patients not on background therapy and 68% for those on lipid-modifying therapy, compared to placebo. The overall success of pegozafermin supports advancing to a Phase 3 trial. This treatment is expected to offer new therapeutic options for SHTG, which affects millions in the U.S., presenting a compelling profile for cardiovascular risk reduction.
89bio, Inc. (Nasdaq: ETNB), a biopharmaceutical company, announced new data from its Phase 2 ENTRIGUE study on pegozafermin for treating severe hypertriglyceridemia (SHTG). The findings will be showcased at the American College of Cardiology's 72nd Annual Scientific Session in New Orleans from March 4-6, 2023. The study, titled 'Pegozafermin Provides Beneficial Lipid Effects in Subjects with Severe Hypertriglyceridemia,' indicates that the treatment could yield significant lipid benefits, regardless of patients' background lipid-modifying therapy. The poster presentation is scheduled for March 4, 2023.
89bio, Inc. (Nasdaq: ETNB), a clinical-stage biopharmaceutical company, announced participation in the SVB Securities Global Biopharma Conference on February 15, 2023, at 12:00 PM ET. Management will engage in a fireside chat and hold one-on-one investor meetings. The event will be available for viewing via a webcast, accessible on their website. 89bio is focused on developing innovative therapies for liver and cardio-metabolic diseases, rapidly advancing its lead candidate, pegozafermin, aimed at treating non-alcoholic steatohepatitis (NASH) and severe hypertriglyceridemia (SHTG). The company is headquartered in San Francisco.
89bio, a clinical-stage biopharmaceutical company, reported significant advancements in its clinical programs for pegozafermin. The company expects topline data from the ENLIVEN Phase 2b NASH trial in Q1 2023 and plans to initiate a Phase 3 trial for severe hypertriglyceridemia (SHTG) in H1 2023, following FDA feedback. Additionally, 89bio secured a $100 million credit facility from K2 HealthVentures, enhancing its financial position with pro forma cash of $188.4 million as of December 31, 2022. These steps signal a positive trajectory for the company's ongoing development of therapies targeting liver and cardio-metabolic diseases.
89bio, a clinical-stage biopharmaceutical company, announced positive results from its Phase 1b/2a study of pegozafermin for treating nonalcoholic steatohepatitis (NASH). Data published in The Lancet Gastroenterology & Hepatology revealed that up to 88% of patients showed a significant reduction in hepatic fat fraction. The treatment was well-tolerated with no severe adverse events, indicating its potential as a leading therapy for NASH. The company is advancing to the Phase 2b ENLIVEN trial, with topline results expected in Q1 2023.
89bio, Inc. (Nasdaq: ETNB) recently reported its Q3 2022 financial results, highlighting completion of enrollment in the Phase 2b ENLIVEN trial for NASH, with topline data expected in Q1 2023. The company also presented encouraging data from its Phase 1b/2a NASH study and the ENTRIGUE Phase 2 trial at major conferences. As of September 30, 2022, 89bio had cash and equivalents of $193.3 million, reporting a net loss of $26.8 million for Q3 2022. The firm anticipates initiating a Phase 3 trial for severe hypertriglyceridemia patients in the first half of 2023.
89bio, Inc. (Nasdaq: ETNB) presented new data from the Phase 1b/2a study on pegozafermin for treating nonalcoholic steatohepatitis (NASH) at the AASLD Liver Meeting 2022. In a post-hoc analysis of cohort 7, it was found that excluding patients with fibrosis stage 4 (F4) improved histological response rates. Out of 19 patients, 6 were identified as F4. Key findings included a 77% response rate for ≥ 2 point reduction in NAS after excluding F4 patients. The company aims to report topline data from the Phase 2b ENLIVEN trial in Q1 2023, further evaluating pegozafermin's efficacy.
89bio, a clinical-stage biopharmaceutical company focusing on therapies for liver and cardio-metabolic diseases, will participate in the H.C. Wainwright 6th Annual NASH Investor Conference on October 17, 2022, at 11:30 AM ET.
Management will engage in a fireside chat and one-on-one investor meetings. The presentation will be available via webcast, accessible here.
89bio, Inc. (Nasdaq: ETNB), a clinical-stage biopharmaceutical company, will participate in the H.C. Wainwright 24th Annual Global Investment Conference on September 12, 2022, at 4:00 PM ET. The event includes a fireside chat and one-on-one investor meetings, accessible via webcast on the company's website. 89bio is focused on developing innovative therapies for liver and cardiometabolic diseases, particularly its lead candidate, pegozafermin, aimed at treating non-alcoholic steatohepatitis (NASH) and severe hypertriglyceridemia (SHTG).
89bio, Inc. (Nasdaq: ETNB) presented positive results from the ENTRIGUE Phase 2 trial of pegozafermin for severe hypertriglyceridemia (SHTG) at the ESC Congress 2022. The treatment significantly reduced triglycerides (TG) across all doses, achieving median reductions of up to 63% compared to a 12% reduction in the placebo group. Pegozafermin also improved liver fat and glycemic control. The findings support advancing into a Phase 3 trial anticipated in the first half of 2023, indicating potential for pegozafermin as a key treatment for cardio-metabolic and liver diseases.