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) has successfully completed enrollment in its Phase 2b ENLIVEN trial of pegozafermin, targeting non-alcoholic steatohepatitis (NASH). A total of 219 patients have been enrolled to receive either active treatment or placebo. Topline data is anticipated in the first quarter of 2023. The trial aims to evaluate the drug's efficacy and safety profile, building on previous positive results. The pegozafermin candidate utilizes innovative technology to enhance its therapeutic potential for patients suffering from liver diseases.
89bio, Inc. (Nasdaq: ETNB) announced positive topline results from the ENTRIGUE Phase 2 trial of pegozafermin for severe hypertriglyceridemia (SHTG) patients, with significant triglyceride reductions (up to 63%). The company plans to initiate a Phase 3 trial in the first half of 2023. They raised $94.5 million from a public offering, bolstering their financial position with a cash balance of approximately $200 million. However, R&D expenses increased to $19.7 million, and net loss widened to $25.1 million. Topline data from the ENLIVEN Phase 2b trial for NASH is anticipated in early 2023.
89bio, Inc. (Nasdaq: ETNB) announced the completion of its underwritten public offering, raising approximately $94.5 million. The offering included 18,675,466 shares of common stock and warrants for 9,337,733 shares, priced at $3.55 per share. Additionally, pre-funded warrants for 7,944,252 shares were issued at $3.549 each. Key institutional investors participated, including BVF Partners and Deep Track Capital. The offering is supported by a valid SEC registration statement effective since April 2021.
89bio, Inc. (Nasdaq: ETNB) announced the pricing of a public offering of 18,675,466 shares of common stock at $3.55 per share, along with warrants for 9,337,733 additional shares. The offering also includes pre-funded warrants for 7,944,252 shares at $3.549 each. The anticipated gross proceeds are approximately $94.5 million, expected to close around July 1, 2022. BofA Securities and SVB Securities are leading the offering. The securities are available through a filed shelf registration statement with the SEC.
On June 28, 2022, 89bio (Nasdaq: ETNB) announced a public offering of $75 million in common stock, including pre-funded warrants for select investors. The offering is contingent on market conditions and entails no guarantees regarding completion terms. Proceeds are earmarked for ongoing clinical development of pegozafermin and other corporate purposes. BofA Securities and SVB Securities are the book-running managers for this initiative. A registration statement has been filed with the SEC, allowing potential investors to access detailed offering information.
89bio announced positive results from the ENTRIGUE trial, which evaluated pegozafermin for severe hypertriglyceridemia. The primary endpoint was met, showing a statistically significant reduction in triglycerides by 63% at the highest dose (p<0.001). Additionally, improvements were observed in non-HDL-C and liver fat. The trial included 85 patients, and pegozafermin demonstrated a favorable safety profile with mild side effects. The company plans to initiate a Phase 3 trial in the first half of 2023, highlighting the potential for pegozafermin as a leading treatment option in the market.
89bio, a clinical-stage biopharmaceutical company, has announced that additional data on pegozafermin for treating non-alcoholic steatohepatitis (NASH) will be presented at the EASL International Liver Congress™ 2022 in London from June 22-26, 2022. Key presentations include:
- Abstract 3535: Improved liver histology and metabolic profile.
- Abstract 3654: Significant metabolic benefits alongside liver improvements.
- Abstract 1520: Pharmacokinetics of BIO89-100 in NASH patients.
Presentations are on June 25, 2022.
89bio, Inc. (Nasdaq: ETNB) reported Q1 2022 financial results, showing a net loss of $25.6 million, up from $14.8 million in Q1 2021, primarily due to increased R&D and G&A expenses. The company aims to report topline data from its ENTRIGUE trial for severe hypertriglyceridemia (SHTG) in Q2 2022 and complete enrollment for its ENLIVEN trial for NASH by Q3 2022. As of March 31, 2022, 89bio held $126.1 million in cash, sufficient to fund operations into the second half of 2023.
89bio, a clinical-stage biopharmaceutical company focused on innovative therapies for liver and cardio-metabolic diseases, will participate in several investor conferences in May 2022. Key events include:
- BofA Securities Healthcare Conference on May 10, 2022, at 4:20 p.m. EST.
- RBC Capital Markets Global Healthcare Conference on May 18, 2022, at 10:30 a.m. EST.
- H.C. Wainwright Global Investment Conference on May 24, 2022, starting at 7:00 a.m. EST.
Webcasts of these presentations will be available on 89bio’s investor website.
89bio to Host KOL Webinar on Severe Hypertriglyceridemia
SAN FRANCISCO, April 26, 2022 – 89bio, a clinical-stage biopharmaceutical company (Nasdaq: ETNB), has announced a webinar scheduled for May 4, 2022, at 11:00 a.m. PT/2:00 p.m. ET. The event will feature presentations from renowned experts Harold Bays, MD, and Deepak L. Bhatt, MD, covering the treatment landscape for severe hypertriglyceridemia (SHTG) and the ENTRIGUE Phase 2 clinical trial of 89bio’s candidate pegozafermin. A Q&A session will also be included, emphasizing the clinical and regulatory development pathway for this innovative therapy.
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