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 headquartered in San Francisco, California. Since its founding in 2018, 89bio has been committed to developing and commercializing innovative therapies for the treatment of liver and cardio-metabolic diseases, addressing critical unmet medical needs.
The company’s lead product candidate is pegozafermin (formerly BIO89-100), a specifically engineered glycoPEGylated analog of fibroblast growth factor 21 (FGF21). Pegozafermin has shown promise in treating nonalcoholic steatohepatitis (NASH) and severe hypertriglyceridemia (SHTG). This candidate targets metabolic dysfunction-associated steatohepatitis (MASH), which can lead to severe liver complications, including cirrhosis and liver failure.
89bio is actively advancing pegozafermin through various phases of clinical trials. Recently, the company announced a successful end-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA), allowing them to proceed to Phase 3 trials. Two Phase 3 trials, ENLIGHTEN-Cirrhosis and ENLIGHTEN-Fibrosis, are set to enroll patients in 2024. The ENLIGHTEN program aims to evaluate the efficacy and safety of pegozafermin in patients with different stages of liver fibrosis.
Pegozafermin has demonstrated strong anti-fibrotic and anti-inflammatory properties in the liver, as well as improved lipid metabolism, insulin resistance, and glycemic control. It has received Breakthrough Therapy designation from the FDA and Priority Medicines (PRIME) status from the European Medicines Agency (EMA), emphasizing its therapeutic potential and the urgency for such treatments.
Financially, 89bio reported substantial cash reserves, ensuring robust support for ongoing clinical activities. As of December 31, 2023, the company had $578.9 million in cash and equivalents. This strong financial position enables continued development and potential scaling up for commercial production.
89bio maintains strategic partnerships to bolster its clinical and commercialization efforts. These collaborations are crucial as the company aims to bring pegozafermin to market, providing solutions for patients with liver and cardio-metabolic diseases who lack effective treatment options.
For more detailed updates, recent financial results, and upcoming milestones, visit their official website or follow their LinkedIn profile.
89bio, Inc. (Nasdaq: ETNB) has announced the pricing of its public offering of 16,923,077 shares of common stock at $16.25 per share, which will raise approximately $275 million in gross proceeds. The offering includes a 30-day option for underwriters to purchase an additional 2,538,461 shares. The offering is expected to close around March 28, 2023, subject to customary conditions. BofA Securities, SVB Securities, and Evercore ISI are acting as lead book-running managers. 89bio focuses on innovative therapies for liver and cardio-metabolic diseases, with its lead candidate targeting non-alcoholic steatohepatitis (NASH).
89bio, a clinical-stage biopharmaceutical company (Nasdaq: ETNB), announced a public offering of $200 million in common stock or pre-funded warrants. The offering includes a 30-day option for underwriters to purchase an additional $30 million. Proceeds will support clinical activities for pegozafermin, focusing on liver and cardio-metabolic diseases. The offering is subject to market conditions. BofA Securities, SVB Securities, and Evercore ISI are the book-running managers. The company emphasizes that this press release is not an offer to sell securities, as per SEC regulations.
89bio, Inc. (ETNB) announced positive results from its Phase 2b ENLIVEN trial of pegozafermin in patients with nonalcoholic steatohepatitis (NASH). The trial demonstrated statistically significant improvements in fibrosis and NASH resolution, with the 44mg Q2W and 30mg QW doses achieving placebo-adjusted effect sizes of 20% and 19% for fibrosis improvement, and 24% and 21% for NASH resolution, respectively. The study's results support progression to Phase 3 trials, highlighting pegozafermin’s potential as a differentiated treatment for NASH. The company’s rigorous methodology adds credibility to the findings.
89bio, a clinical-stage biopharmaceutical company, reported significant advancements in its late-stage development program for pegozafermin. Key updates include topline results from the ENLIVEN Phase 2b trial for NASH, anticipated in Q1 2023, and FDA feedback supporting a Phase 3 program for severe hypertriglyceridemia (SHTG), with trials set to begin in Q2 2023. Financially, the company held $188.2 million in cash as of December 31, 2022, a rise from $150.7 million in 2021. However, net losses increased to $102 million for the year, driven by higher R&D and G&A expenses.
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.
FAQ
What is the current stock price of 89bio (ETNB)?
What is the market cap of 89bio (ETNB)?
What is 89bio, Inc.'s lead product candidate?
What diseases is 89bio focusing on?
What recent regulatory milestones has 89bio achieved?
When are the Phase 3 trials for pegozafermin expected to begin?
What financial position is 89bio currently in?
What are some key features of pegozafermin?
How does 89bio plan to use proceeds from recent offerings?
What is the ENLIGHTEN program?
What makes pegozafermin potentially best-in-class?
Where can I find more information about 89bio's updates and milestones?
