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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, Inc. (Nasdaq: ETNB) announced positive topline results from the ENTRIGUE Phase 2 trial of pegozafermin for severe hypertriglyceridemia (SHTG) patients, with significant triglyceride reductions (up to 63%). The company plans to initiate a Phase 3 trial in the first half of 2023. They raised $94.5 million from a public offering, bolstering their financial position with a cash balance of approximately $200 million. However, R&D expenses increased to $19.7 million, and net loss widened to $25.1 million. Topline data from the ENLIVEN Phase 2b trial for NASH is anticipated in early 2023.
89bio, Inc. (Nasdaq: ETNB) announced the completion of its underwritten public offering, raising approximately $94.5 million. The offering included 18,675,466 shares of common stock and warrants for 9,337,733 shares, priced at $3.55 per share. Additionally, pre-funded warrants for 7,944,252 shares were issued at $3.549 each. Key institutional investors participated, including BVF Partners and Deep Track Capital. The offering is supported by a valid SEC registration statement effective since April 2021.
89bio, Inc. (Nasdaq: ETNB) announced the pricing of a public offering of 18,675,466 shares of common stock at $3.55 per share, along with warrants for 9,337,733 additional shares. The offering also includes pre-funded warrants for 7,944,252 shares at $3.549 each. The anticipated gross proceeds are approximately $94.5 million, expected to close around July 1, 2022. BofA Securities and SVB Securities are leading the offering. The securities are available through a filed shelf registration statement with the SEC.
On June 28, 2022, 89bio (Nasdaq: ETNB) announced a public offering of $75 million in common stock, including pre-funded warrants for select investors. The offering is contingent on market conditions and entails no guarantees regarding completion terms. Proceeds are earmarked for ongoing clinical development of pegozafermin and other corporate purposes. BofA Securities and SVB Securities are the book-running managers for this initiative. A registration statement has been filed with the SEC, allowing potential investors to access detailed offering information.
89bio announced positive results from the ENTRIGUE trial, which evaluated pegozafermin for severe hypertriglyceridemia. The primary endpoint was met, showing a statistically significant reduction in triglycerides by 63% at the highest dose (p<0.001). Additionally, improvements were observed in non-HDL-C and liver fat. The trial included 85 patients, and pegozafermin demonstrated a favorable safety profile with mild side effects. The company plans to initiate a Phase 3 trial in the first half of 2023, highlighting the potential for pegozafermin as a leading treatment option in the market.
89bio, a clinical-stage biopharmaceutical company, has announced that additional data on pegozafermin for treating non-alcoholic steatohepatitis (NASH) will be presented at the EASL International Liver Congress™ 2022 in London from June 22-26, 2022. Key presentations include:
- Abstract 3535: Improved liver histology and metabolic profile.
- Abstract 3654: Significant metabolic benefits alongside liver improvements.
- Abstract 1520: Pharmacokinetics of BIO89-100 in NASH patients.
Presentations are on June 25, 2022.
89bio, Inc. (Nasdaq: ETNB) reported Q1 2022 financial results, showing a net loss of $25.6 million, up from $14.8 million in Q1 2021, primarily due to increased R&D and G&A expenses. The company aims to report topline data from its ENTRIGUE trial for severe hypertriglyceridemia (SHTG) in Q2 2022 and complete enrollment for its ENLIVEN trial for NASH by Q3 2022. As of March 31, 2022, 89bio held $126.1 million in cash, sufficient to fund operations into the second half of 2023.
89bio, a clinical-stage biopharmaceutical company focused on innovative therapies for liver and cardio-metabolic diseases, will participate in several investor conferences in May 2022. Key events include:
- BofA Securities Healthcare Conference on May 10, 2022, at 4:20 p.m. EST.
- RBC Capital Markets Global Healthcare Conference on May 18, 2022, at 10:30 a.m. EST.
- H.C. Wainwright Global Investment Conference on May 24, 2022, starting at 7:00 a.m. EST.
Webcasts of these presentations will be available on 89bio’s investor website.
89bio to Host KOL Webinar on Severe Hypertriglyceridemia
SAN FRANCISCO, April 26, 2022 – 89bio, a clinical-stage biopharmaceutical company (Nasdaq: ETNB), has announced a webinar scheduled for May 4, 2022, at 11:00 a.m. PT/2:00 p.m. ET. The event will feature presentations from renowned experts Harold Bays, MD, and Deepak L. Bhatt, MD, covering the treatment landscape for severe hypertriglyceridemia (SHTG) and the ENTRIGUE Phase 2 clinical trial of 89bio’s candidate pegozafermin. A Q&A session will also be included, emphasizing the clinical and regulatory development pathway for this innovative therapy.
89bio reported significant advancements in its clinical programs, revealing positive topline results from cohort 7 in the Phase 1b/2a NASH trial for pegozafermin. The data showed that 74% of patients achieved a 2-point or greater improvement in NAFLD Activity Score. The company anticipates topline data from the ENLIVEN Phase 2b NASH trial in the first half of 2023 and has closed enrollment in the ENTRIGUE trial, with results expected in Q2 2022. Financially, the company reported a net loss of $90.1 million for 2021, an increase attributed to higher R&D and G&A expenses.
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