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), 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.
89bio (Nasdaq: ETNB) has announced the approval of Inducement Grants by its Compensation Committee. These grants include non-qualified stock options for 19,800 shares to two new employees and 350,000 shares to the newly-hired Chief Operating Officer, Francis Sarena. The grants, made on August 5, 2024, are part of the company's 2023 Inducement Plan and comply with Nasdaq Listing Rule 5635(c)(4).
The exercise price of the options is equal to 89bio's closing stock price on the grant date. The vesting schedule spans 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 Francis Sarena as Chief Operating Officer, effective August 5, 2024. This strategic move comes as the company advances its Phase 3 clinical program for pegozafermin and prepares for potential scale-up, regulatory filings, and commercialization. Sarena brings 25 years of experience in the biotech industry, including leadership roles at Apexigen, Five Prime Therapeutics, and PDL BioPharma.
Pegozafermin, 89bio's lead candidate, is positioned as a potentially best-in-class FGF21 therapy for MASH patients with advanced fibrosis and compensated cirrhosis, as well as for SHTG patients. The company aims to capitalize on pegozafermin's promising clinical data to address significant unmet medical needs and capture substantial market opportunities.
89bio (Nasdaq: ETNB) reported Q2 2024 financial results and corporate updates. The company is advancing three Phase 3 trials for pegozafermin in MASH (metabolic dysfunction-associated steatohepatitis) and SHTG (severe hypertriglyceridemia). Key highlights include:
1. Initiated ENLIGHTEN-Cirrhosis Phase 3 trial for MASH patients with compensated cirrhosis (F4).
2. Ongoing enrollment in ENLIGHTEN-Fibrosis for non-cirrhotic MASH and ENTRUST for SHTG.
3. Cash position of $531.4 million as of June 30, 2024.
4. Q2 2024 net loss of $48.0 million, up from $38.4 million in Q2 2023.
5. R&D expenses increased to $44.9 million in Q2 2024 from $34.9 million in Q2 2023.
The company expects topline data from the ENTRUST trial in 2025 and is preparing for potential commercialization of pegozafermin.
89bio, Inc. (Nasdaq: ETNB) has appointed Dr. Charles McWherter to its Board of Directors, effective July 30, 2024. Dr. McWherter, former Chief Scientific Officer and President of Research and Development at CymaBay Therapeutics, brings extensive expertise in drug development and liver disease. His appointment comes as 89bio advances Phase 3 trials for pegozafermin in non-cirrhotic and cirrhotic MASH (Metabolic dysfunction-Associated SteatoHepatitis) and SHTG (Severe HyperTriglyceridemia).
CEO Rohan Palekar highlighted Dr. McWherter's valuable experience in liver inflammation and fibrosis, which aligns with 89bio's goal to establish pegozafermin as a potential cornerstone therapy. Dr. McWherter expressed enthusiasm about joining 89bio, citing pegozafermin's promising potential based on the Phase 2b ENLIVEN trial results, including benefits in fibrosis reduction and metabolic improvement.
On July 12, 2024, 89bio, a clinical-stage biopharmaceutical firm, announced the approval of non-qualified stock options for six new employees. The compensation committee of the board of directors granted these options on July 9, 2024, under the 2023 Inducement Plan, aligning with Nasdaq Listing Rule 5635(c)(4). The options allow the purchase of 125,000 shares at the closing price of the company's stock on the grant date. These options will vest over four years: 25% after one year of employment and the remaining shares in 12 equal quarterly installments, contingent on continued employment.
89bio announced the approval of inducement grants under Nasdaq Listing Rule 5635(c)(4) by its Compensation Committee. The grants, totaling 25,500 shares of common stock, were extended to two new employees on June 10, 2024, as part of the company's 2023 Inducement Plan. The exercise price for these stock options matches 89bio's closing stock price on the grant date. These grants will vest over four years, with 25% vesting after one year, followed by quarterly vesting contingent upon continued employment.
89bio, a clinical-stage biopharmaceutical company, will present 48-week data from its Phase 2b ENLIVEN trial evaluating pegozafermin in patients with metabolic dysfunction-associated steatohepatitis (MASH) at the EASL International Liver Congress in Milan, Italy, from June 5 to 8, 2024. The data highlights pegozafermin as the first FGF21 analog showing positive, sustained benefits over 48 weeks in patients with advanced MASH. The presentation will cover the drug's efficacy, tolerability, and improvements in liver health markers, and will be delivered by Dr. Rohit Loomba on June 8.
89bio has initiated the Phase 3 ENLIGHTEN-Cirrhosis trial for pegozafermin in patients with MASH and compensated cirrhosis (F4). This is the first FGF21 analog to reach this trial stage for this patient subset. The trial will involve 760 patients, assessing fibrosis regression at 24 months, potentially supporting accelerated approval in the U.S. and Europe. The trial's primary goal is to observe clinical outcome events for confirmatory or full approval. The ENLIGHTEN-Cirrhosis trial builds on promising Phase 2b results showing improvements in liver health markers, aiming to meet the urgent need for effective therapies in MASH with compensated cirrhosis.
89bio, Inc. announced the approval of non-qualified stock options for four new employees under the 2023 Inducement Plan. The options allow the purchase of 48,150 shares of the Company's common stock at the closing price on May 6, 2024. The options will vest over a four-year period, contingent on continued employment.