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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.

Rhea-AI Summary
89bio, Inc. (ETNB) has been granted Breakthrough Therapy Designation (BTD) for pegozafermin in treating NASH with fibrosis. The company expects regulatory feedback on its Phase 3 development program this quarter. Data from ENLIVEN in patients with cirrhotic (F4) NASH will be presented at AASLD. Financial results for Q3 2023 show $448.3 million in cash and a net loss of $34.7 million.
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89bio to participate in H.C. Wainwright NASH Investor Conference
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89bio approves grant of non-qualified stock options to new employees
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FDA grants Breakthrough Therapy Designation to pegozafermin in NASH patients, positive data from Phase 2b trial
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89bio, Inc. to participate in fireside chat and investor meetings at Cantor Global Healthcare Conference
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89bio, Inc. announces participation in H.C. Wainwright conference
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89bio, Inc. (Nasdaq: ETNB) reported positive results from Phase 2 trials of pegozafermin in NASH and SHTG, with plans to initiate Phase 3 trials. The company published data from the ENLIVEN Phase 2b trial in The New England Journal of Medicine, validating the therapeutic utility of pegozafermin. Discussions with regulatory agencies for Phase 3 NASH program are planned for the second half of 2023. The ENTRUST Phase 3 trial of pegozafermin in patients with severe hypertriglyceridemia (SHTG) has been initiated, and the Phase 2 ENTRIGUE trial results were published in Nature Medicine.
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89bio, Inc. announced that positive data from the Phase 2 ENTRIGUE trial of pegozafermin in patients with severe hypertriglyceridemia (SHTG) were published online in Nature Medicine. The data showed significant reductions in triglycerides, atherogenic lipoproteins, and liver fat. The trial also met multiple secondary endpoints, demonstrating improvements in metabolic measures and markers of liver inflammation. Pegozafermin was well tolerated with a favorable safety profile.
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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

ETNB Rankings

ETNB Stock Data

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