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 ...

公司概况 - 公司是一家专注于开发和商业化治疗肝脏和心脏代谢疾病创新疗法的临床阶段生物制药公司[8] - 公司的主要产品候选药物pegozafermin是一种特异性工程化的glycoPEG化的FGF21类似物，目前正在开发用于治疗非酒精性脂肪肝病（NASH）和严重高三酰甘油血症（SHTG）[8] - 公司的战略重点包括快速推进pegozafermin在NASH治疗领域的临床开发，推进pegozafermin在SHTG治疗领域的开发，扩大和优化pegozafermin的生产，以及在关键地区建立商业基础设施[11] NASH治疗 - NASH是非酒精性脂肪肝病的严重形式，目前没有治疗该疾病的批准产品，而pegozafermin在NASH患者中显示出积极的结果[8][13] - NASH的发病机制包括脂质代谢能力降低、胰岛素抵抗增加、肝细胞损伤和肝纤维化等，患者通常伴有其他代谢性共病，如肥胖、高血糖、血脂异常和高血压，增加心血管疾病风险[13][14] - Pegozafermin可能成为NASH治疗的重要选择，因为它不仅可以改善肝脏病变，还可以影响恶化NASH的多种共病症[9][12] SHTG治疗 - SHTG是指血清甘油三酯水平≥500 mg/dL，美国有约400万患者，其中约80万患者未得到充分治疗[15] - SHTG患者中高达100%存在临床意义的肝脂肪，70%患有2型糖尿病，65%患有高LDL，市场潜力随着对高甘油三酯水平治疗重要性认识提高而扩大[15] - Pegozafermin是唯一一种用于治疗SHTG的FGF21类似物，其广泛的代谢效应可能使其在市场上有差异化优势[10] 临床试验和研发 - 公司在 NASH 患者中进行的 Phase 1b/2a 临床试验显示，使用 pegozafermin 可以显著减少肝脂肪含量，相对基线减少高达 60%，相对安慰剂减少高达 70%[33] - 公司成功与 FDA 结束了 Phase 2 会议，支持将 pegozafermin 推进至 NASH 的 Phase 3 项目，计划包括两个评估 NASH 患者的 Phase 3 试验[48] - 公司计划的 ENLIGHTEN 程序将包括两个 Phase 3 试验，分别评估 F4 级别的代偿性肝硬化患者和 F2-F3 级别的纤维化患者[49] 生产和监管 - 生物制品在美国受到《联邦食品、药品和化妆品法》等法规监管[69] - 制造过程的变更受到严格监管，可能需要FDA的事先批准[81] - 制造商必须继续投入时间、金钱和精力以保持符合cGMP和其他监管要求[82] 法规和政策 - 美国政府通过了Inflation Reduction Act of 2022（IRA），授权美国卫生与公众服务部与参与的制药公司就联邦医疗保健计划中的某些药物进行价格谈判[94] - IRA为CMS提供了重要的新权力，旨在遏制药品成本并鼓励市场竞争[94] - 如果没有生物类似药物的生物制剂药物延迟了生物类似药物的市场进入超过两年，CMS将被授权对生物制剂制造商进行价格谈判，以确保公平竞争[95]

Exhibit 99.1 89bio Reports Fourth Quarter and Full Year 2023 Financial Results and Provides Corporate Updates – Plan to initiate the Phase 3 ENLIGHTEN NASH program for non-cirrhotic (F2-F3) and cirrhotic (F4) patients in the first and second quarters of 2024, respectively – – Long-term data from Phase 2b ENLIVEN trial demonstrated sustained benefits of pegozafermin at week 48 in patients with advanced NASH, which was consistent across patient sub-groups – – Data from Phase 2b ENLIVEN trial in patients with ...

公司动态 - 89bio公司宣布董事会薪酬委员会批准向两名新员工授予非限制性股票期权[1] - 这些诱因授予的股票期权的行权价格等于89bio公司股票在授予日期的收盘价[2] - 89bio公司致力于为患有肝脏和心脏代谢疾病的患者开发最佳疗法，重点推进其主力候选药物pegozafermin的临床开发[3]

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 September 30, 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 (S ...

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 June 30, 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 ...

产品信息 - Pegozafermin是一种FGF21类似物，通过优化工程实现了平衡疗效和长效间隔[7] - Pegozafermin在NASH患者中展示出显著的NASH解决率，无肝纤维化恶化[22] - Pegozafermin在F4肝硬化患者中表现出肝脂肪显著减少[27] - Pegozafermin在不同剂量下对甘油三酯的降低效果明显，尤其在每周一次的剂量下[43] - Pegozafermin在改善非HDL-C和Apo-B方面表现出临床意义[44] 市场机会 - Pegozafermin在治疗NASH和SHTG方面具有巨大的商业机会[34] - SHTG患者群体庞大，存在高度未满足的需求[51] 未来展望 - 公司计划在2023年上半年启动第三阶段项目[50] 公司信息 - 公司进入NASH和SHTG的第三阶段临床开发，拥有强劲的资产负债表（4.809亿美元现金、现金等价物和短期投资）[6] - 公司管理团队经验丰富，为公司成功奠定基础[56]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 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, 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 o ...

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, 2022 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 (I.R.S. ...