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 presented new analyses from the Phase 2b ENLIVEN trial evaluating pegozafermin in MASH patients with advanced fibrosis at The Liver Meeting® 2024. The post-hoc analyses demonstrate pegozafermin's potential anti-fibrotic effects and the utility of non-invasive tests (NITs) in correlating with histological endpoints. The data, presented in four poster sessions, showed that pegozafermin improved FAST scores and achieved both MASH resolution and fibrosis improvement, suggesting its effectiveness in preventing progression to cirrhosis in advanced MASH patients. The findings support the design of upcoming Phase 3 trials for both cirrhotic and non-cirrhotic MASH.
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.
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