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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, Inc. (Nasdaq: ETNB) reported its Q1 2024 financial results, highlighting the initiation of Phase 3 trials for pegozafermin in MASH patients, EMA's PRIME status, and positive data from the ENLIVEN Phase 2b Trial. The company also entered a collaboration agreement for commercial supply and appointed a new Board member. Financially, 89bio had $562.3 million in cash, R&D expenses increased to $47.4 million, G&A expenses rose to $9.8 million, resulting in a net loss of $51.7 million.

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89bio, Inc. (Nasdaq: ETNB) will participate in the BofA Securities 2024 Health Care Conference to present their innovative therapies for liver and cardiometabolic diseases. The presentation is scheduled for May 15, 2024, at 2:20 PM PDT.

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89bio, Inc. (Nasdaq: ETNB) will host a key opinion leader event discussing pegozafermin's potential in advanced metabolic dysfunction-associated steatohepatitis (MASH) on May 16, 2024, featuring expert hepatologist Arun Sanyal, M.D. The webinar will cover the ENLIGHTEN-Cirrhosis trial and the commercial prospects for pegozafermin in advanced MASH.

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89bio, Inc. appoints Martin Babler, a biotech industry veteran, to its Board of Directors. Babler brings over 30 years of pharmaceutical and biotech experience to the company. His successful track record in building and leading companies through commercialization will be valuable as 89bio progresses with its Phase 3 programs for pegozafermin, a treatment for liver and cardiometabolic diseases.
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89bio, Inc. announced the approval of non-qualified stock options for eight new employees under the 2023 Inducement Plan. The options grant a total of 138,550 shares of common stock, with a four-year vesting period. The exercise price matches the closing price on the grant date, following Nasdaq Listing Rule 5635(c)(4).
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89bio, Inc. (ETNB) receives PRIME status from EMA for pegozafermin in MASH patients. Positive data from Phase 2b trial supports the status. Phase 3 trials for non-cirrhotic and cirrhotic patients underway. CEO Rohan Palekar emphasizes pegozafermin's potential in treating MASH patients with advanced fibrosis.
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89bio, Inc. initiates Phase 3 ENLIGHTEN Program for pegozafermin in MASH patients. The program includes two trials, with the first focusing on non-cirrhotic MASH patients with fibrosis stage F2-F3. Co-primary endpoints at week 52 aim to support accelerated approval. The second trial will evaluate patients with compensated cirrhosis. Pegozafermin shows promising anti-fibrotic and metabolic effects, with potential for full approval.
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89bio, Inc. (ETNB) announces the grant of non-qualified stock options to a new employee as an inducement for joining the company. The grant includes 10,800 shares of common stock, with a four-year vesting period based on continued employment.
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89bio, Inc. (ETNB) to participate in Leerink Partners Global Biopharma Conference for investor meetings and fireside chat on March 12, 2024.
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89bio, Inc. (ETNB) plans to initiate Phase 3 trials for NASH patients in 2024, with positive long-term data from Phase 2b trials. The company completed a follow-on offering for $172.5 million, with a strong financial position of $578.9 million in cash and securities by December 31, 2023.
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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