临床试验进展 - 89bio启动了两项III期临床试验,分别针对非肝硬化的代谢相关性脂肪肝炎(ENLIGHTEN-Fibrosis)和代谢相关性脂肪肝炎合并代偿性肝硬化(ENLIGHTEN-Cirrhosis)[2][6] - ENLIGHTEN-Cirrhosis III期试验将入组约760名患者,评估pegozafermin治疗代谢相关性脂肪肝炎合并代偿性肝硬化的疗效[6] - ENTRUST III期试验正在持续入组,评估pegozafermin治疗严重高三酰甘油血症的疗效和安全性,预计2025年公布结果[7] 财务状况 - 公司现金、现金等价物和可流通证券余额为5.314亿美元[9] - 研发费用同比增加28.5%至4489万美元,主要由于临床试验、合同生产和人员相关费用增加[10] - 管理费用同比增加19.4%至860万美元,主要由于专业服务费和人员相关费用增加[11] - 净亏损同比增加25.0%至4797万美元,主要由于研发和管理费用增加,部分被利息收入增加所抵消[12]

SAN FRANCISCO, Aug. 05, 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 the appointment of Dr. Charles McWherter to its Board of Directors, effective July 30, 2024. Dr. McWherter most recently served as Chief Scientific Officer and President of Research and Development of CymaBay Therapeutics until it was acquired by ...

mi-viri 89bio, Inc. (NASDAQ:ETNB) is a clinical-stage biopharmaceutical company based in San Francisco, California. The company focuses on developing therapies for liver and cardiometabolic conditions with its drug candidate, pegozafermin. This medicine is a fibroblast growth factor 21 (FGF21) analog used to regulate metabolic processes like glucose and lipid metabolism. It is indicated for metabolic dysfunction-associated steatohepatitis [MASH] and severe hypertriglyceridemia [SHTG]. Pegozafermin has s ...

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 Euro ...

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 ...

—With the initiation of ENLIGHTEN-Cirrhosis, pegozafermin is the first FGF21 analog to enter a Phase 3 trial in MASH patients with compensated cirrhosis (F4)— —Regression of fibrosis by histology at month 24 will serve as the basis for potential accelerated approval with clinical outcomes to support the potential for confirmatory or full approval— SAN FRANCISCO, May 14, 2024 (GLOBE NEWSWIRE) -- 89bio, Inc. (NASDAQ:ETNB), a clinical-stage biopharmaceutical company focused on the development and commercializa ...

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 89bio Reports First Quarter 2024 Financial Results and Provides Corporate Update –Initiated Phase 3 ENLIGHTEN-Fibrosis trial in non-cirrhotic (F2-F3) metabolic dysfunction-associated steatohepatitis (MASH) patients– –Expect to initiate ENLIGHTEN-Cirrhosis trial this quarter in MASH patients with compensated cirrhosis (F4)– –Granted Priority Medicines (PRIME) status from the European Medicines Agency (EMA) for pegozafermin in the treatment of MASH with fibrosis and compensated cirrhosis– –Data f ...

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 ...