SAN FRANCISCO, May 22, 2024 (GLOBE NEWSWIRE) -- 89bio, Inc. (Nasdaq: ETNB), a clinical-stage biopharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of liver and cardiometabolic diseases, today announced that data from the 48-week extension phase of the Phase 2b ENLIVEN trial evaluating pegozafermin in patients with metabolic dysfunction-associated steatohepatitis (MASH) with fibrosis will be presented in an oral and poster presentation at the Eur ...

SAN FRANCISCO, May 22, 2024 (GLOBE NEWSWIRE) -- 89bio, Inc. (Nasdaq: ETNB), a clinical-stage biopharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of liver and cardiometabolic diseases, today announced that data from the 48-week extension phase of the Phase 2b ENLIVEN trial evaluating pegozafermin in patients with metabolic dysfunction-associated steatohepatitis (MASH) with fibrosis will be presented in an oral and poster presentation at the Eur ...

Core Insights - 89bio, Inc. has initiated the ENLIGHTEN-Cirrhosis trial, marking pegozafermin as the first FGF21 analog to enter a Phase 3 trial for MASH patients with compensated cirrhosis (F4) [1][3] - The trial aims to evaluate the efficacy of pegozafermin in reversing fibrosis, with potential for accelerated approval based on histological evidence [2][3] Company Overview - 89bio is a clinical-stage biopharmaceutical company focused on developing therapies for liver and cardiometabolic diseases, particularly MASH and severe hypertriglyceridemia [7] - The company is headquartered in San Francisco and is dedicated to advancing its lead candidate, pegozafermin, through clinical development [7] Trial Details - The ENLIGHTEN-Cirrhosis trial is a global, randomized, double-blind, placebo-controlled study enrolling approximately 760 patients, with a 1:1 randomization to receive either 30mg of pegozafermin weekly or a placebo [2][5] - The primary endpoint is defined as fibrosis regression from F4 to an earlier stage, with an interim analysis at 24 months to support potential accelerated approval in the U.S. and conditional approval in Europe [2][3] Disease Context - MASH, also known as nonalcoholic steatohepatitis (NASH), is a chronic condition characterized by liver fat accumulation, inflammation, and potential progression to fibrosis and cirrhosis [4] - By 2030, MASH is projected to affect over 27 million people in the U.S., with approximately 20% of patients potentially developing cirrhosis [4] Pegozafermin Profile - Pegozafermin is a glycoPEGylated analog of FGF21, demonstrating anti-fibrotic and anti-inflammatory effects, along with improvements in triglyceride levels and insulin resistance [6] - The drug has received Breakthrough Therapy designation from the FDA and Priority Medicines status from the EMA for treating MASH with fibrosis [6] ENLIGHTEN Program - The ENLIGHTEN program consists of two Phase 3 trials: ENLIGHTEN-Cirrhosis for compensated cirrhosis (F4) and ENLIGHTEN-Fibrosis for non-cirrhotic MASH (F2-F3) [5] - The co-primary endpoints for ENLIGHTEN-Fibrosis include a one-point improvement in fibrosis and MASH resolution without worsening fibrosis, assessed at week 52 [5]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _______________to ____________ Commission File Number: 001-39122 89bio, Inc. (Exact Name of Registrant as Specified in its Charter) Delaware 36-4946844 (State ...

Exhibit 99.1 –Granted Priority Medicines (PRIME) status from the European Medicines Agency (EMA) for pegozafermin in the treatment of MASH with fibrosis and compensated cirrhosis– –Data from the 48-Week Extension Phase of the ENLIVEN Phase 2b Trial to be presented at the European Association for the Study of the Liver Congress (EASL)– SAN FRANCISCO, May 9, 2024 (GLOBE NEWSWIRE) – 89bio, Inc. (Nasdaq: ETNB), a clinical-stage biopharmaceutical company focused on the development and commercialization of innova ...

Investors might want to bet on 89BIO (ETNB) , as it has been recently upgraded to a Zacks Rank #2 (Buy). This upgrade primarily reflects an upward trend in earnings estimates, which is one of the most powerful forces impacting stock prices.A company's changing earnings picture is at the core of the Zacks rating. The system tracks the Zacks Consensus Estimate -- the consensus measure of EPS estimates from the sell-side analysts covering the stock -- for the current and following years.Since a changing earnin ...

—Co-primary endpoints in ENLIGHTEN-Fibrosis assessed at week 52 will potentially support accelerated approval in non-cirrhotic MASH (fibrosis stage F2-F3) patients— —ENLIGHTEN-Cirrhosis, the second trial in the program, is planned to evaluate patients with compensated cirrhosis (F4) and is expected to initiate in the second quarter of 2024— SAN FRANCISCO, March 12, 2024 (GLOBE NEWSWIRE) -- 89bio, Inc. (NASDAQ:ETNB), a clinical-stage biopharmaceutical company focused on the development and commercialization ...

Shares of 89BIO (ETNB) have gained 40.5% over the past four weeks to close the last trading session at $13.77, but there could still be a solid upside left in the stock if short-term price targets of Wall Street analysts are any indication. Going by the price targets, the mean estimate of $30.50 indicates a potential upside of 121.5%.The average comprises 10 short-term price targets ranging from a low of $15 to a high of $50, with a standard deviation of $9.07. While the lowest estimate indicates an increas ...

After reaching an important support level, 89BIO (ETNB) could be a good stock pick from a technical perspective. ETNB surpassed resistance at the 200-day moving average, suggesting a long-term bullish trend.The 200-day simple moving average is widely-used by traders and analysts, and helps establish market trends for stocks, commodities, indexes, and other financial instruments over the long term. The indicator moves higher or lower together with longer-term price moves, serving as a support or resistance l ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD FROM TO Commission File Number 001-39122 89bio, Inc. (Exact name of registrant as specified in its Charter) Delaware 36-4946844 (State or other jurisdiction of incorpor ...