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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), a clinical-stage biopharmaceutical company, 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 event will be available via live and archived webcast on the company's website. 89bio is focused on developing innovative therapies for liver and cardio-metabolic diseases, with its lead product candidate, BIO89-100, targeting NASH and severe hypertriglyceridemia. The company is based in San Francisco and has operations in Israel.

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89bio, Inc. (Nasdaq: ETNB) has announced the pricing of an upsized public offering of 3,300,000 shares at $28.00 each, aiming for gross proceeds of approximately $84.7 million. The offering consists of 3,025,000 shares from 89bio and 275,000 shares from a selling stockholder. Additionally, the underwriters have a 30-day option to purchase up to 495,000 additional shares. The offering is expected to close on September 21, 2020, pending customary conditions. BofA Securities, SVB Leerink, and RBC Capital Markets are leading the offering.

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89bio, a clinical-stage biopharmaceutical company (Nasdaq: ETNB), announced a public offering of 3,000,000 shares of common stock. This includes 2,700,000 shares from the company and 300,000 shares from stockholders. There is also an option for underwriters to purchase an additional 450,000 shares. The proceeds will support the BIO89-100 programs targeting nonalcoholic steatohepatitis (NASH) and severe hypertriglyceridemia (SHTG). The offering depends on market conditions and a registration statement that has yet to become effective.

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89bio (Nasdaq: ETNB) announced positive topline results from its Phase 1b/2a trial of BIO89-100, an investigational FGF21 analog for nonalcoholic steatohepatitis (NASH). All dose groups achieved significant liver fat reductions, with up to 70% versus placebo. Notably, 88% of subjects had at least a 30% reduction in liver fat. The treatment demonstrated a strong safety profile, with low adverse event incidence. BIO89-100 is positioned as a promising therapy for NASH, with further trials planned in 2021.

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89bio, Inc. (Nasdaq: ETNB) announced plans to share topline safety, tolerability, and efficacy data from its Phase 1b/2a study of BIO89-100 for NASH on September 14, 2020. The presentation will take place during a pre-market conference call at 8:30 AM PT, featuring a live webcast accessible through the company’s website. BIO89-100 is a glycoPEGylated analog of FGF21 aimed at treating NASH and severe hypertriglyceridemia. Investors can find further information on the event and future developments on the company’s investor relations page.

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89bio, Inc. (Nasdaq: ETNB) announced the initiation of a Phase 2 trial for BIO89-100, targeting severe hypertriglyceridemia (SHTG), with enrollment of approximately 90 participants. This double-blind, placebo-controlled study seeks to evaluate the safety and efficacy of BIO89-100, a glycoPEGylated analog of FGF21. The primary endpoint focuses on reducing fasting triglycerides, while secondary endpoints include effects on other lipids and liver fat reduction. This study builds on promising early clinical data suggesting significant metabolic benefits, addressing a crucial need for alternative therapies.

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89bio, a clinical-stage biopharmaceutical company (Nasdaq: ETNB), announced CEO Rohan Palekar's participation in two upcoming conferences. He will speak at the BTIG Virtual Biotechnology Conference on August 10, 2020, at 11:30 AM ET, and at the Canaccord Genuity 40th Annual Growth Conference on August 12, 2020, at 10:00 AM ET. The company is developing therapies for liver and cardio-metabolic diseases, including its lead candidate, BIO89-100, targeted for NASH treatment. Webcasts will be available on their website after the events.

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89bio, Inc. (Nasdaq: ETNB) has completed its upsized public offering of 3,047,040 shares of common stock, including the underwriters' additional purchase option. The offering price was $27.50 per share, generating approximately $83.8 million in gross proceeds, before expenses. This fundraise will support the development of innovative therapies for liver and cardio-metabolic diseases, particularly their lead candidate, BIO89-100, which is currently in clinical trials for NASH and NAFLD. The offering was led by BofA Securities, SVB Leerink, and RBC Capital Markets.

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89bio, a clinical-stage biopharmaceutical company, announced an upsized public offering of 2,649,600 shares at $27.50 each, totaling approximately $72.9 million in gross proceeds. The underwriters also have a 30-day option to buy an additional 397,440 shares. The offering is expected to close on July 10, 2020. Major financial institutions, including BofA Securities and SVB Leerink, are managing the offering. The proceeds are aimed at advancing 89bio’s development of innovative therapies for liver and cardio-metabolic diseases, specifically targeting NASH and SHTG.

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89bio, a clinical-stage biopharmaceutical company (Nasdaq: ETNB), has announced a public offering of 2,200,000 shares of its common stock, with an option for underwriters to purchase an additional 330,000 shares. Proceeds will support the acceleration of its BIO89-100 programs for treating nonalcoholic steatohepatitis (NASH) and severe hypertriglyceridemia (SHTG). The offering is contingent on market conditions, and full details will be available in the prospectus.

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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