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.
Overview
89Bio, Inc. (symbol: ETNB) is a United States-based clinical-stage biopharmaceutical company committed to advancing innovative therapies for patients with liver and cardiometabolic diseases. Employing cutting-edge glycoPEGylation technology, the company is focused on enhancing the biological activity and prolonging the half-life of its therapeutic candidates through advanced drug engineering. With a robust pipeline centered on conditions such as metabolic dysfunction-associated steatohepatitis (MASH) and severe hypertriglyceridemia (SHTG), 89Bio is addressing significant unmet clinical needs with precision and scientific rigor.
Core Business and Product Pipeline
The company’s primary focus is on the development and eventual commercialization of pegozafermin, a specifically engineered fibroblast growth factor 21 (FGF21) analog. This molecule, enhanced by unique glycoPEGylated technology, has been designed to exert potent anti-fibrotic and metabolic effects. It aims to treat advanced liver conditions by reducing fibrosis and ameliorating metabolic dysregulation, a dual approach that positions 89Bio uniquely in the biotech landscape. Beyond its lead candidate, the company continues to explore additional therapeutic avenues within the liver and cardiometabolic realms, ensuring a diversified approach to clinical development.
Clinical Development and Research
89Bio has structured its clinical research around rigorous Phase 3 trials, notably the ENLIGHTEN program, which encompasses pivotal studies in both non-cirrhotic MASH (with fibrosis stages F2-F3) and MASH with compensated cirrhosis (F4). These randomized, double-blind, placebo-controlled trials are designed to evaluate key endpoints such as histological improvements in liver fibrosis and resolution of steatohepatitis. By integrating noninvasive diagnostic tools alongside traditional biopsy assessments, the company aims to streamline patient evaluation and enhance the sensitivity of therapeutic response measurement. Moreover, the advanced design of these trials reflects 89Bio's commitment to scientific excellence and clear regulatory communication, as evidenced by recent supportive designations from global regulatory bodies.
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.