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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

週三生物技術催化劑綜述-當天結束摘要
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.
  • 美國食品和藥物管理局(FDA)已批准藍鳥傳記藍鳥公司(納斯達克代碼：BLUE)的領先資產ZYNTEGLO(貝貝格基因自體)用於治療需要定期輸血的成人和兒童患者貝塔-地中海貧血的潛在遺傳原因。藍鳥公司的股票價格在6.13美元到8.18美元之間，一天成交量為2,726萬股，常規交易時段收於6.78美元。該公司股票目前為7.25美元，在盤後交易中上漲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.
  • 三星生物科技和有機體(紐約證券交易所股票代碼：OGN)宣佈，美國食品和藥物管理局(FDA)已經批准了HADLIMA(adalimumab-bwwd)的無檸檬酸、高濃度(100毫克/毫升)配方，這是一種生物相似的參考HUMIRA®(阿達利單抗)。HADLIMA將提供預充式注射器和自動注射器選項，自動注射器是專門為患者設計的。Organon的股價在30.61美元至31.13美元的範圍內交易，當日成交量為109萬股，常規交易時段收於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.
  • 歐盟委員會已批准將孤兒藥物指定給紅山生物口服液納斯達克(Sequoia Capital：RDHL)治療非結核分枝桿菌疾病的主要資產RHB-204的股票價格在1.01美元至1.12美元之間，當日成交量為425萬股，常規交易時段收於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.
  • 新西蘭醫療安全局已批准擴大臨時批准範圍諾華納斯達克(Sequoia Capital：NVAX)的主要資產新諾沃韋(Nuvaxovid-CoV2373)新冠肺炎主動免疫疫苗預防2019年冠狀病毒病(新冠肺炎)是由18歲及以上成年人使用的異源和同源強化劑嚴重急性呼吸綜合徵冠狀病毒2(SARS-CoV-2)引起的。新華三的股價在39.26美元至42.65美元的範圍內交易，日成交量為579萬股，常規交易時段收盤報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納斯達克公司(Temasek Holdings：PALI)在其評估鉛資產LB1148的第三階段研究中給第一名患者服用了加速接受胃腸道手術的成年患者的腸道功能恢復的藥物。Palisade的股價在0.15美元至0.19美元的範圍內交易，當日成交量為3444萬股，常規交易時段收於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.
  • 藍圖藥品納斯達克：BPMC宣佈了AYVAKIT先鋒臨牀試驗第二部分註冊的正面結果(Avapritinib)治療非進展期系統性肥大細胞增多症(SM)。BluePrint的股價在52美元至64.44美元的範圍內交易，當日成交量為696萬股，常規交易時段收於61.17美元。該公司股票目前的交易價格為59.08美元，在盤後交易中下跌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.
  • 美國食品和藥物管理局(FDA)對Omeros納斯達克(JD：OMER)向FDA提交了正式的爭議解決請求，對FDA審查部門早些時候決定為那索普利單抗治療造血幹細胞移植相關血栓性微血管病(HSCT-TMA)的生物製品許可證申請(BLA)發出完整的回覆函提出上訴。Omeros的股價在6.37美元至7.2美元的範圍內交易，當日成交量為950.28萬股，常規交易時段收於6.63美元。
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