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.
89bio, Inc. (Nasdaq: ETNB) is a clinical-stage biopharmaceutical company headquartered in San Francisco, California. Since its founding in 2018, 89bio has been committed to developing and commercializing innovative therapies for the treatment of liver and cardio-metabolic diseases, addressing critical unmet medical needs.
The company’s lead product candidate is pegozafermin (formerly BIO89-100), a specifically engineered glycoPEGylated analog of fibroblast growth factor 21 (FGF21). Pegozafermin has shown promise in treating nonalcoholic steatohepatitis (NASH) and severe hypertriglyceridemia (SHTG). This candidate targets metabolic dysfunction-associated steatohepatitis (MASH), which can lead to severe liver complications, including cirrhosis and liver failure.
89bio is actively advancing pegozafermin through various phases of clinical trials. Recently, the company announced a successful end-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA), allowing them to proceed to Phase 3 trials. Two Phase 3 trials, ENLIGHTEN-Cirrhosis and ENLIGHTEN-Fibrosis, are set to enroll patients in 2024. The ENLIGHTEN program aims to evaluate the efficacy and safety of pegozafermin in patients with different stages of liver fibrosis.
Pegozafermin has demonstrated strong anti-fibrotic and anti-inflammatory properties in the liver, as well as improved lipid metabolism, insulin resistance, and glycemic control. It has received Breakthrough Therapy designation from the FDA and Priority Medicines (PRIME) status from the European Medicines Agency (EMA), emphasizing its therapeutic potential and the urgency for such treatments.
Financially, 89bio reported substantial cash reserves, ensuring robust support for ongoing clinical activities. As of December 31, 2023, the company had $578.9 million in cash and equivalents. This strong financial position enables continued development and potential scaling up for commercial production.
89bio maintains strategic partnerships to bolster its clinical and commercialization efforts. These collaborations are crucial as the company aims to bring pegozafermin to market, providing solutions for patients with liver and cardio-metabolic diseases who lack effective treatment options.
For more detailed updates, recent financial results, and upcoming milestones, visit their official website or follow their LinkedIn profile.
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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