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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.

News

89bio Announces Inducement Grant Under Nasdaq Listing Rule 5635(c)(4)

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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 to Participate in the Leerink Partners Global Biopharma Conference

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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 Reports Fourth Quarter and Full Year 2023 Financial Results and Provides Corporate Updates

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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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89bio to Participate in the Oppenheimer 34th Annual Healthcare Life Sciences Conference

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89bio, Inc. (ETNB) to present at Oppenheimer 34th Annual Healthcare Life Sciences Conference, showcasing their focus on innovative therapies for liver and cardiometabolic diseases. The webcast will be available on the company's website.
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89bio Announces Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)

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89bio, Inc. announced the approval of non-qualified stock options for two new employees as part of the 2023 Inducement Plan. The options allow the purchase of 28,400 shares of the company's common stock at the closing price on the grant date. The options will vest over a four-year period, subject to the employees' continued employment.
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89bio Announces Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)

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89bio, Inc. (ETNB) Announces Approval of Non-Qualified Stock Options for New Employees
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89bio Announces Closing of its Upsized Public Offering and Full Exercise of Underwriters’ Option to Purchase Additional Shares

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89bio, Inc. (ETNB) successfully closed an upsized underwritten public offering, raising approximately $172.5 million. The company sold 17,567,567 shares of its common stock and pre-funded warrants to purchase up to 1,081,081 shares. The offering was led by BofA Securities and Leerink Partners, with H.C. Wainwright & Co. as the lead manager. The gross proceeds will be used for the development and commercialization of innovative therapies for liver and cardiometabolic diseases.
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89bio, Inc. Announces Upsized Pricing of $150.0 Million Public Offering of Common Stock and Pre-Funded Warrants

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89bio, Inc. (ETNB) announces the pricing of an upsized underwritten public offering of 15,135,135 shares of its common stock at a public offering price per share of $9.25, with expected gross proceeds of approximately $150.0 million.
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89bio, Inc. Announces Proposed Underwritten Public Offering of Common Stock and Pre-Funded Warrants

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89bio, Inc. (ETNB) has announced a public offering of $125.0 million of its common stock or pre-funded warrants. The company aims to use the proceeds for clinical activities, development of pegozafermin, manufacturing scale-up, and general corporate purposes. The offering is subject to market conditions and will be managed by BofA Securities, Leerink Partners, Cantor, Raymond James, UBS Investment Bank, and H.C. Wainwright & Co.
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89bio Reaches Alignment with the FDA and EMA on Phase 3 Program for Pegozafermin in Nonalcoholic Steatohepatitis (NASH); Program Initiation Planned in the First Half of 2024

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89bio, Inc. (ETNB) successfully concluded an end-of-Phase 2 Meeting with the FDA, supporting the advancement of pegozafermin into Phase 3 in NASH. The program will include two Phase 3 trials evaluating patients with NASH: ENLIGHTEN-Cirrhosis for F4 patients and ENLIGHTEN-Fibrosis for F2-F3 patients. The FDA has agreed to an accelerated approval pathway for both F4 and F2-F3 NASH patients using histology. The safety database will include data from the ongoing SHTG Phase 3 program. The trials will include patients on background GLP-1 therapy to assess the potential combination with pegozafermin. The ENLIGHTEN program will evaluate the efficacy and safety of pegozafermin in patients with NASH, with the trials expected to initiate in the first and second quarter of 2024.
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FAQ

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

The current stock price of 89bio (ETNB) is $7.96 as of January 3, 2025.

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

The market cap of 89bio (ETNB) is approximately 937.1M.

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.
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89bio, Inc.

Nasdaq:ETNB

ETNB Rankings

#2603 Ranked by Market Cap
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ETNB Stock Data

937.13M
115.50M
0.76%
97.23%
5.9%
Biotechnology
Pharmaceutical Preparations
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United States of America
SAN FRANCISCO