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) has announced the pricing of an upsized public offering of 3,300,000 shares at $28.00 each, aiming for gross proceeds of approximately $84.7 million. The offering consists of 3,025,000 shares from 89bio and 275,000 shares from a selling stockholder. Additionally, the underwriters have a 30-day option to purchase up to 495,000 additional shares. The offering is expected to close on September 21, 2020, pending customary conditions. BofA Securities, SVB Leerink, and RBC Capital Markets are leading the offering.
89bio, a clinical-stage biopharmaceutical company (Nasdaq: ETNB), announced a public offering of 3,000,000 shares of common stock. This includes 2,700,000 shares from the company and 300,000 shares from stockholders. There is also an option for underwriters to purchase an additional 450,000 shares. The proceeds will support the BIO89-100 programs targeting nonalcoholic steatohepatitis (NASH) and severe hypertriglyceridemia (SHTG). The offering depends on market conditions and a registration statement that has yet to become effective.
89bio (Nasdaq: ETNB) announced positive topline results from its Phase 1b/2a trial of BIO89-100, an investigational FGF21 analog for nonalcoholic steatohepatitis (NASH). All dose groups achieved significant liver fat reductions, with up to 70% versus placebo. Notably, 88% of subjects had at least a 30% reduction in liver fat. The treatment demonstrated a strong safety profile, with low adverse event incidence. BIO89-100 is positioned as a promising therapy for NASH, with further trials planned in 2021.
89bio, Inc. (Nasdaq: ETNB) announced plans to share topline safety, tolerability, and efficacy data from its Phase 1b/2a study of BIO89-100 for NASH on September 14, 2020. The presentation will take place during a pre-market conference call at 8:30 AM PT, featuring a live webcast accessible through the company’s website. BIO89-100 is a glycoPEGylated analog of FGF21 aimed at treating NASH and severe hypertriglyceridemia. Investors can find further information on the event and future developments on the company’s investor relations page.
89bio, Inc. (Nasdaq: ETNB) announced the initiation of a Phase 2 trial for BIO89-100, targeting severe hypertriglyceridemia (SHTG), with enrollment of approximately 90 participants. This double-blind, placebo-controlled study seeks to evaluate the safety and efficacy of BIO89-100, a glycoPEGylated analog of FGF21. The primary endpoint focuses on reducing fasting triglycerides, while secondary endpoints include effects on other lipids and liver fat reduction. This study builds on promising early clinical data suggesting significant metabolic benefits, addressing a crucial need for alternative therapies.
89bio, a clinical-stage biopharmaceutical company (Nasdaq: ETNB), announced CEO Rohan Palekar's participation in two upcoming conferences. He will speak at the BTIG Virtual Biotechnology Conference on August 10, 2020, at 11:30 AM ET, and at the Canaccord Genuity 40th Annual Growth Conference on August 12, 2020, at 10:00 AM ET. The company is developing therapies for liver and cardio-metabolic diseases, including its lead candidate, BIO89-100, targeted for NASH treatment. Webcasts will be available on their website after the events.
89bio, Inc. (Nasdaq: ETNB) has completed its upsized public offering of 3,047,040 shares of common stock, including the underwriters' additional purchase option. The offering price was $27.50 per share, generating approximately $83.8 million in gross proceeds, before expenses. This fundraise will support the development of innovative therapies for liver and cardio-metabolic diseases, particularly their lead candidate, BIO89-100, which is currently in clinical trials for NASH and NAFLD. The offering was led by BofA Securities, SVB Leerink, and RBC Capital Markets.
89bio, a clinical-stage biopharmaceutical company, announced an upsized public offering of 2,649,600 shares at $27.50 each, totaling approximately $72.9 million in gross proceeds. The underwriters also have a 30-day option to buy an additional 397,440 shares. The offering is expected to close on July 10, 2020. Major financial institutions, including BofA Securities and SVB Leerink, are managing the offering. The proceeds are aimed at advancing 89bio’s development of innovative therapies for liver and cardio-metabolic diseases, specifically targeting NASH and SHTG.
89bio, a clinical-stage biopharmaceutical company (Nasdaq: ETNB), has announced a public offering of 2,200,000 shares of its common stock, with an option for underwriters to purchase an additional 330,000 shares. Proceeds will support the acceleration of its BIO89-100 programs for treating nonalcoholic steatohepatitis (NASH) and severe hypertriglyceridemia (SHTG). The offering is contingent on market conditions, and full details will be available in the prospectus.
89bio, Inc. (Nasdaq: ETNB) announced its Q1 2020 financial results, reporting a net loss of $10.5 million compared to $4.4 million in Q1 2019. The increase in loss is linked to higher R&D expenses of $7.8 million, up from $4.3 million a year earlier, and G&A expenses rising to $2.9 million from $0.5 million. The company closed enrollment in its Phase 1b/2a NASH trial with 98% of patients enrolled, expecting topline results in 2H20. Additionally, the FDA cleared its IND application for BIO89-100 targeting severe hypertriglyceridemia, paving the way for a Phase 2 trial when conditions allow.
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