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 announced the pricing of its upsized public offering, consisting of 11,455,882 shares of common stock at $8.50 per share and pre-funded warrants to purchase 3,250,000 shares at $8.499 per share. The pre-funded warrants have an exercise price of $0.001 and are immediately exercisable. The company granted underwriters a 30-day option to purchase up to 2,205,882 additional shares. The offering, expected to close around November 14, 2024, aims to raise approximately $125.0 million in gross proceeds. Goldman Sachs, Leerink Partners, and Evercore ISI are serving as book-running managers.
89bio (Nasdaq: ETNB) announced a proposed underwritten public offering of $100 million of common stock and pre-funded warrants. The company will grant underwriters a 30-day option to purchase up to an additional $15 million of shares. The proceeds will fund ongoing clinical activities and development of pegozafermin, manufacturing costs, and general corporate purposes. Goldman Sachs, Leerink Partners, and Evercore ISI are acting as book-running managers for the offering.
89bio (ETNB) reported Q3 2024 financial results and corporate updates. The company continues to advance its Phase 3 ENLIGHTEN trials for MASH and ENTRUST trial for SHTG, with topline data expected in 2025. Key financial highlights include cash position of $423.8 million, R&D expenses of $141.4 million (up from $31.4 million in Q3 2023), and a net loss of $149.1 million (increased from $34.7 million). The company secured an amended credit facility up to $150 million with K2 HealthVentures. Notable appointments include Charles McWherter to Board of Directors, Francis Sarena as COO, and Teresa Perney as Chief Regulatory Officer.
89bio (Nasdaq: ETNB) has announced its participation in the upcoming UBS Global Healthcare Conference. The company's management will engage in a fireside chat on Tuesday, November 12, 2024, at 12:30 PM EST, along with one-on-one investor meetings. The presentation will be available via webcast on 89bio's investor website section, with replay access for approximately 30 days after the conference. 89bio is a clinical-stage biopharmaceutical company developing innovative therapies for liver and cardiometabolic diseases.
89bio (Nasdaq: ETNB) announced that new analyses from the Phase 2b ENLIVEN trial of pegozafermin in patients with metabolic dysfunction-associated steatohepatitis (MASH) with fibrosis will be presented at the 75th Annual AASLD The Liver Meeting® 2024. The presentations include four poster sessions focusing on:
- Biomarker response in high-risk MASH patients
- Reduction in progression to cirrhosis
- Machine learning integration for biomarker assessments
- Diagnostic potential of FAST and AGILE3+ scores for F2/F3 fibrosis
The presentations will take place on November 15-16, 2024, in San Diego, California, featuring research from prominent medical professionals in the field of liver health.
89bio, Inc. (Nasdaq: ETNB), a clinical-stage biopharmaceutical company focusing on liver and cardiometabolic diseases, has announced the approval of Inducement Grants by its Compensation Committee. These grants, made under the company's 2023 Inducement Plan, include non-qualified stock options to purchase 265,000 shares of common stock, awarded to two new employees on October 10, 2024.
The Inducement Grants, aligned with Nasdaq Listing Rule 5635(c)(4), have an exercise price equal to the closing price of 89bio's common stock on the grant date. They will vest over four years, with 25% vesting after one year and the remainder in 12 equal quarterly installments, contingent on continued employment.
89bio, Inc. (Nasdaq: ETNB), a clinical-stage biopharmaceutical company focused on developing innovative therapies for liver and cardiometabolic diseases, has announced its participation in the H.C. Wainwright 8th Annual MASH Investor Conference. The company's management will take part in a fireside chat and one-on-one investor meetings on Monday, October 7, 2024, at 11:30 AM ET.
Investors and interested parties can access the webcast of the presentation through the investor section of 89bio's website. A replay of the webcast will be available for approximately 30 days after the conference. This event provides an opportunity for 89bio to showcase its progress and engage with potential investors in the biopharmaceutical sector.
89bio, Inc. (Nasdaq: ETNB), a clinical-stage biopharmaceutical company focusing on liver and cardiometabolic diseases, has announced an inducement grant approved by its Compensation Committee. The grant includes non-qualified stock options to purchase 15,000 shares of the company's common stock, awarded to one new employee on September 13, 2024.
The grant, made under the company's 2023 Inducement Plan, complies with Nasdaq Listing Rule 5635(c)(4). The exercise price equals the closing price of 89bio's common stock on the grant date. The options will vest over four years, with 25% vesting after one year and the remainder vesting in 12 equal quarterly installments, contingent on continued employment.
89bio (Nasdaq: ETNB) has appointed Dr. Teresa Perney as Chief Regulatory and Quality Officer, effective immediately. Dr. Perney brings over 20 years of experience in the biotech and pharmaceutical industry, with expertise in regulatory affairs, product development, and quality assurance. This appointment comes as 89bio advances pegozafermin through multiple global Phase 3 studies for liver and cardiometabolic diseases.
CEO Rohan Palekar emphasized that Dr. Perney's expertise will be important in shaping the company's global regulatory strategy and potentially accelerating the delivery of pegozafermin to patients worldwide. Dr. Perney expressed excitement about joining 89bio at this pivotal moment and leveraging her experience to address unmet needs in liver and cardiometabolic diseases.
89bio, Inc. (Nasdaq: ETNB), a clinical-stage biopharmaceutical company focusing on liver and cardiometabolic diseases, has announced its participation in three upcoming investor conferences in September 2024:
- Wells Fargo 2024 Healthcare Conference on September 5 at 12:45 PM ET (Fireside Chat)
- H.C. Wainwright 26th Annual Global Investment Conference on September 9 at 11:30 AM ET (Presentation)
- 2024 Cantor Global Healthcare Conference on September 17 at 11:30 AM ET (Fireside Chat)
Webcasts of these presentations will be available on 89bio's website, with replays accessible for approximately 30 days after each conference.
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