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Recap Of Wednesday's Biotech Catalysts - End Of the Day Summary

Recap Of Wednesday's Biotech Catalysts - End Of the Day Summary

周三生物技术催化剂综述-当天结束摘要
Benzinga Real-time News ·  2022/08/17 18:34
  • The U.S. Food and Drug Administration (FDA) has approved Bluebird bio's (NASDAQ:BLUE) lead asset ZYNTEGLO (betibeglogene autotemcel) to treat the underlying genetic cause of beta‑thalassemia in adult and pediatric patients who require regular red blood cell (RBC) transfusions. Bluebird shares traded in a range of $6.13 to $8.18 on a day volume of 27.26 million shares, closed regular trading session at $6.78. The company shares are currently trading at $7.25, up 6.93 percent in the after-hours trading session.
  • 美国食品和药物管理局(FDA)已批准蓝鸟传记蓝鸟公司(纳斯达克代码：BLUE)的领先资产ZYNTEGLO(贝贝格基因自体)用于治疗需要定期输血的成人和儿童患者贝塔-地中海贫血的潜在遗传原因。蓝鸟公司的股票价格在6.13美元到8.18美元之间，一天成交量为2,726万股，常规交易时段收于6.78美元。该公司股票目前为7.25美元，在盘后交易中上涨6.93%。
  • Samsung Bioepis and Organon (NYSE:OGN) announced the U.S. Food and Drug Administration (FDA) has approved the citrate-free, high-concentration (100 mg/mL) formulation of HADLIMA (adalimumab-bwwd), a biosimilar referencing HUMIRA® (adalimumab). HADLIMA will be available in pre-filled syringe and autoinjector options, and the autoinjector was specifically designed with the patient in mind. Organon shares traded in a range of $30.61 to $31.13 on a day volume of 1.09 million shares, closed regular trading session at $30.87.
  • 三星生物科技和有机体(纽约证券交易所股票代码：OGN)宣布，美国食品和药物管理局(FDA)已经批准了HADLIMA(adalimumab-bwwd)的无柠檬酸、高浓度(100毫克/毫升)配方，这是一种生物相似的参考HUMIRA®(阿达利单抗)。HADLIMA将提供预充式注射器和自动注射器选项，自动注射器是专门为患者设计的。Organon的股价在30.61美元至31.13美元的范围内交易，当日成交量为109万股，常规交易时段收于30.87美元。
  • The European Commission has granted Orphan Drug Designation to RedHill Biopharma's  (NASDAQ:RDHL) lead asset RHB-204 for the treatment of nontuberculous mycobacteria (NTM) disease. RedHill shares traded in a range of $1.01 to $1.12 on a day volume of 4.25 million shares, closed regular trading session at $1.07.
  • 欧盟委员会已批准将孤儿药物指定给红山生物口服液纳斯达克(Sequoia Capital：RDHL)治疗非结核分枝杆菌疾病的主要资产RHB-204的股票价格在1.01美元至1.12美元之间，当日成交量为425万股，常规交易时段收于1.07美元。
  • The New Zealand's Medsafe has granted expanded provisional approval for Novavax's (NASDAQ:NVAX) lead asset  Nuvaxovid (NVX-CoV2373) COVID-19 vaccine for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) as a heterologous and homologous booster dose in adults aged 18 and older. Novavax shares traded in a range of $39.26 to $42.65 on a day volume of 5.79 million shares, closed regular trading session at $39.37.
  • 新西兰医疗安全局已批准扩大临时批准范围诺华纳斯达克(Sequoia Capital：NVAX)的主要资产新诺沃韦(Nuvaxovid-CoV2373)新冠肺炎主动免疫疫苗预防2019年冠状病毒病(新冠肺炎)是由18岁及以上成年人使用的异源和同源强化剂严重急性呼吸综合征冠状病毒2(SARS-CoV-2)引起的。新华三的股价在39.26美元至42.65美元的范围内交易，日成交量为579万股，常规交易时段收盘报39.37美元。
  • Palisade Bio (NASDAQ:PALI) has dosed first patient in its Phase 3 study evaluating lead asset LB1148 to accelerate the return of bowel function in adult patients undergoing gastrointestinal surgery. Palisade shares traded in a range of $0.15 to $0.19 on a day volume of 34.44 million shares, closed regular trading session at $0.16.
  • Palisade Bio纳斯达克公司(Temasek Holdings：PALI)在其评估铅资产LB1148的第三阶段研究中给第一名患者服用了加速接受胃肠道手术的成年患者的肠道功能恢复的药物。Palisade的股价在0.15美元至0.19美元的范围内交易，当日成交量为3444万股，常规交易时段收于0.16美元。
  • Blueprint Medicines (NASDAQ:BPMC) announced positive top-line results from the registrational Part 2 of the PIONEER clinical trial of AYVAKIT (avapritinib) in patients with non-advanced systemic mastocytosis (SM). Blueprint shares traded in a range of $52 to $64.44 on a day volume of 6.96 milion shares, closed regular trading session at $61.17. The company shares are currently trading at $59.08, down 3.42 percent in the after-hours trading session.
  • 蓝图药品纳斯达克：BPMC宣布了AYVAKIT先锋临床试验第二部分注册的正面结果(Avapritinib)治疗非进展期系统性肥大细胞增多症(SM)。BluePrint的股价在52美元至64.44美元的范围内交易，当日成交量为696万股，常规交易时段收于61.17美元。该公司股票目前的交易价格为59.08美元，在盘后交易中下跌3.42%。
  • The United States Food and Drug Administration (FDA) provided an interim response to Omeros' (NASDAQ:OMER) formal dispute resolution request submitted to the Agency, appealing the earlier decision by the FDA review division to issue a complete response letter for the biologics license application (BLA) for narsoplimab in the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy (HSCT-TMA). Omeros shares traded in a range of $6.37 to $7.2 on a day volume of 950.28 thousand shares, closed regular trading session at $6.63.
  • 美国食品和药物管理局(FDA)对Omeros纳斯达克(JD：OMER)向FDA提交了正式的争议解决请求，对FDA审查部门早些时候决定为那索普利单抗治疗造血干细胞移植相关血栓性微血管病(HSCT-TMA)的生物制品许可证申请(BLA)发出完整的回复函提出上诉。Omeros的股价在6.37美元至7.2美元的范围内交易，当日成交量为950.28万股，常规交易时段收于6.63美元。
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