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.
About 89bio, Inc.
89bio, Inc. (Nasdaq: ETNB) is a clinical-stage biopharmaceutical company headquartered in San Francisco, California, dedicated to the development and commercialization of innovative therapies for liver and cardiometabolic diseases. The company’s mission is to address unmet medical needs in these areas by advancing its lead product candidate, pegozafermin, a glycoPEGylated analog of fibroblast growth factor 21 (FGF21). Pegozafermin is specifically engineered to optimize biological activity through an extended half-life, making it a promising therapeutic option for complex conditions such as metabolic dysfunction-associated steatohepatitis (MASH)—formerly known as nonalcoholic steatohepatitis (NASH)—and severe hypertriglyceridemia (SHTG).
Core Focus and Product Pipeline
The company’s primary focus is on developing pegozafermin for the treatment of MASH, a chronic and progressive liver disease characterized by fat accumulation, inflammation, and fibrosis, which can lead to cirrhosis, liver failure, or hepatocellular carcinoma. Pegozafermin is also being developed for SHTG, a condition marked by dangerously high triglyceride levels that increase the risk of pancreatitis and cardiovascular disease. Both indications represent significant unmet medical needs, with limited treatment options available.
Pegozafermin has demonstrated encouraging results in clinical trials, showing potential anti-fibrotic, anti-inflammatory, and metabolic benefits. The company is currently advancing pegozafermin through multiple Phase 3 clinical trials under its ENLIGHTEN and ENTRUST programs. These trials aim to evaluate the efficacy and safety of pegozafermin in both non-cirrhotic and cirrhotic MASH patients, as well as in individuals with SHTG. The company’s clinical strategy is bolstered by regulatory designations such as Breakthrough Therapy status from the U.S. FDA and PRIME designation from the European Medicines Agency (EMA), which underscore the potential of pegozafermin to address critical unmet needs.
Competitive Positioning
89bio operates in a competitive biopharmaceutical landscape, with other companies also pursuing therapies for NASH/MASH and SHTG. However, the company differentiates itself through its proprietary glycoPEGylation technology, which enhances the pharmacokinetics and therapeutic potential of pegozafermin. Clinical data from the Phase 2b ENLIVEN trial demonstrated statistically significant improvements in liver histology, non-invasive biomarkers, and metabolic parameters, positioning pegozafermin as a potentially best-in-class FGF21 analog.
Challenges and Opportunities
Like other clinical-stage biopharmaceutical companies, 89bio faces challenges such as clinical trial risks, regulatory approval processes, and the need for substantial capital to fund its development programs. The competitive landscape for MASH and SHTG therapies also necessitates differentiation through clinical efficacy, safety, and patient convenience. Nonetheless, the company’s robust clinical pipeline, strategic focus on high-need indications, and strong regulatory support provide a solid foundation for potential success.
Conclusion
89bio, Inc. is at the forefront of developing transformative therapies for liver and cardiometabolic diseases. By leveraging its expertise in FGF21 biology and glycoPEGylation technology, the company aims to deliver innovative solutions for patients with MASH and SHTG, addressing significant gaps in current treatment paradigms. With its lead candidate pegozafermin progressing through late-stage clinical trials, 89bio is well-positioned to make a meaningful impact in the biopharmaceutical industry.
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.
89bio reported significant advancements in its clinical programs, revealing positive topline results from cohort 7 in the Phase 1b/2a NASH trial for pegozafermin. The data showed that 74% of patients achieved a 2-point or greater improvement in NAFLD Activity Score. The company anticipates topline data from the ENLIVEN Phase 2b NASH trial in the first half of 2023 and has closed enrollment in the ENTRIGUE trial, with results expected in Q2 2022. Financially, the company reported a net loss of $90.1 million for 2021, an increase attributed to higher R&D and G&A expenses.
FAQ
What is the current stock price of 89Bio (ETNB)?
What is the market cap of 89Bio (ETNB)?
What is 89bio's primary focus?
What is pegozafermin?
What differentiates 89bio from competitors?
What clinical trials is 89bio currently conducting?
What regulatory designations has pegozafermin received?
What are the key benefits of pegozafermin?
What challenges does 89bio face?
Where is 89bio headquartered?
What is the significance of glycoPEGylation technology?
What is MASH, and why is it significant?
