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89bio, Inc. - ETNB STOCK NEWS

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.

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89bio, a clinical-stage biopharmaceutical company, announced participation in the virtual H.C. Wainwright Global Life Sciences Conference on March 9-10, 2021. The presentation will be available on-demand starting at 7 a.m. EST on March 9, with an archived webcast accessible on 89bio’s website. The company focuses on innovative therapies for liver and cardio-metabolic diseases, notably their lead candidate BIO89-100, targeting nonalcoholic steatohepatitis (NASH) and severe hypertriglyceridemia (SHTG). 89bio is based in San Francisco.

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89bio, a clinical-stage biopharmaceutical company, announced it will provide a corporate update and engage in one-on-one investor meetings at the Raymond James 42nd Annual Institutional Investors Conference on March 3, 2021, at 12:30 PM ET. The presentation will be accessible via the conference portal. 89bio focuses on therapies for liver and cardio-metabolic diseases, with its lead product BIO89-100 targeting NASH and severe hypertriglyceridemia.

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89bio, a clinical-stage biopharmaceutical company specializing in treatments for liver and cardio-metabolic diseases, announced a corporate update at the SVB Leerink 10th Annual Global Healthcare Conference on February 25, 2021, at 5:00 PM ET. The event will feature one-on-one investor meetings and a presentation accessible via the conference portal. The company's lead candidate, BIO89-100, targets nonalcoholic steatohepatitis (NASH) and severe hypertriglyceridemia (SHTG). For more details, the webcast will be archived on 89bio’s investor section.

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89bio, Inc. (Nasdaq: ETNB) announced significant advancements in its clinical development program for BIO89-100, targeted at liver and cardio-metabolic diseases. The company is set to initiate a Phase 2b NASH trial in 1H21 and expects topline data from the open-label histology cohort by year-end 2021. The Phase 2 SHTG trial is also underway, with results anticipated in 2H21. Encouraging data from a previous Phase 1b/2a trial indicated reductions in liver fat of up to 70% and significant improvements in ALT and triglycerides, showcasing the positive risk-benefit profile of BIO89-100.

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89bio, Inc. (Nasdaq: ETNB), a clinical-stage biopharmaceutical company focused on innovative therapies for liver and cardio-metabolic diseases, will present a corporate update at the virtual H.C. Wainwright BioConnect 2021 Conference from January 11-14, 2021. CEO Rohan Palekar's presentation will be available on-demand starting at 6 a.m. EST on January 11. The archived webcast can be accessed in the investor section of 89bio’s website. The company’s lead product, BIO89-100, targets nonalcoholic steatohepatitis (NASH) and severe hypertriglyceridemia (SHTG).

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89bio, Inc (Nasdaq: ETNB), a clinical-stage biopharmaceutical company, will have its CEO, Rohan Palekar, participate in investor meetings at the Piper Sandler 32nd Annual Virtual Healthcare Conference on December 2, 2020. The conference runs from December 1-3, 2020. An archived webcast of the discussion will be available on 89bio’s website.

89bio is focused on therapies for liver and cardio-metabolic diseases, with its lead candidate, BIO89-100, aimed at treating nonalcoholic steatohepatitis (NASH) and severe hypertriglyceridemia (SHTG).

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89bio, Inc. (Nasdaq: ETNB) announced updated positive data from its Phase 1b/2a study of BIO89-100, a treatment for nonalcoholic steatohepatitis (NASH). The study demonstrates significant reductions in liver fat, ALT levels, and triglycerides across various dosing groups with favorable tolerability. Notably, 88% of patients achieved a ≥30% reduction in liver fat. The company plans to initiate a Phase 2b study in early 2021, emphasizing its commitment to addressing NASH's unmet medical needs.

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89bio, Inc. (Nasdaq: ETNB) announced significant advancements in its clinical development program during Q3 2020. Positive results from the Phase 1b/2a trial of BIO89-100 for NASH highlighted a 70% liver fat reduction and excellent tolerability. The company is set to present data at the AASLD Liver Meeting and initiate a Phase 2b trial in NASH in H1 2021. Financially, 89bio reported a net loss of $14.6 million, improving from $18.7 million year-over-year, with cash reserves at $219.2 million, supporting ongoing research initiatives.

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89bio, Inc. (Nasdaq: ETNB) announced the presentation of promising clinical data for its drug BIO89-100 targeted at treating nonalcoholic steatohepatitis (NASH) during The Liver Meeting Digital Experience™ 2020 from November 13-16. Results from a Phase 1b/2a study revealed significant reductions in liver fat via MRI-PDFF, with favorable safety and tolerability profiles, suggesting potential best-in-class dosing. The study demonstrated robust efficacy with both weekly and biweekly dosing, highlighting the drug's potential as a treatment in a field lacking approved options.

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89bio, a clinical-stage biopharmaceutical company focused on liver and cardio-metabolic diseases, announced that CEO Rohan Palekar will present at the H.C. Wainwright 4th Annual NASH Investor Conference on October 5, 2020, at 11:30 AM ET. The presentation will be available via live and archived webcast on the company’s website. 89bio's lead product, BIO89-100, targets nonalcoholic steatohepatitis (NASH) and severe hypertriglyceridemia (SHTG). The company is headquartered in San Francisco with operations in Herzliya, Israel.

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FAQ

What is the current stock price of 89bio (ETNB)?

The current stock price of 89bio (ETNB) is $7.93 as of November 15, 2024.

What is the market cap of 89bio (ETNB)?

The market cap of 89bio (ETNB) is approximately 857.0M.

What is 89bio, Inc.'s lead product candidate?

89bio's lead product candidate is pegozafermin, a glycoPEGylated analog of fibroblast growth factor 21 (FGF21) for treating nonalcoholic steatohepatitis (NASH) and severe hypertriglyceridemia (SHTG).

What diseases is 89bio focusing on?

89bio focuses on developing therapies for liver and cardio-metabolic diseases, particularly nonalcoholic steatohepatitis (NASH) and severe hypertriglyceridemia (SHTG).

What recent regulatory milestones has 89bio achieved?

89bio has successfully completed an end-of-Phase 2 meeting with the FDA, allowing them to advance pegozafermin into Phase 3 trials. They have also received Breakthrough Therapy designation from the FDA and PRIME status from the EMA.

When are the Phase 3 trials for pegozafermin expected to begin?

The Phase 3 trials, ENLIGHTEN-Cirrhosis and ENLIGHTEN-Fibrosis, are expected to commence in the first and second quarters of 2024, respectively.

What financial position is 89bio currently in?

As of December 31, 2023, 89bio had cash, cash equivalents, and marketable securities totaling $578.9 million, supporting their ongoing clinical activities and development efforts.

What are some key features of pegozafermin?

Pegozafermin has demonstrated direct anti-fibrotic and anti-inflammatory effects on the liver, reduced triglyceride levels, improved insulin resistance, and maintained a favorable safety and tolerability profile.

How does 89bio plan to use proceeds from recent offerings?

The proceeds will fund ongoing clinical activities, development of pegozafermin, manufacturing scale-up, and general corporate purposes, including working capital and operating expenses.

What is the ENLIGHTEN program?

The ENLIGHTEN program consists of two Phase 3 trials evaluating the efficacy and safety of pegozafermin in patients with nonalcoholic steatohepatitis (NASH), targeting different stages of liver fibrosis.

What makes pegozafermin potentially best-in-class?

Pegozafermin is a specifically engineered, glycoPEGylated FGF21 analog with an extended half-life, optimizing its biological activity and providing strong therapeutic benefits.

Where can I find more information about 89bio's updates and milestones?

For detailed updates, recent financial results, and upcoming milestones, visit 89bio's official website or follow their LinkedIn profile.

89bio, Inc.

Nasdaq:ETNB

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856.97M
106.13M
0.64%
101.13%
5.08%
Biotechnology
Pharmaceutical Preparations
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United States of America
SAN FRANCISCO