bluebird bio (BLUE) Soars on FDA Approval of 'Abecma' Drug Developed Together with Bristol-Myers Squibb (BMY), Analysts Bullish
bluebird bio (BLUE) Soars on FDA Approval of 'Abecma' Drug Developed Together with Bristol-Myers Squibb (BMY), Analysts Bullish
Shares of bluebird bio (NASDAQ: BLUE) soared over 9% in pre-open Monday after the company’s “Abecma” therapy, developed together with Bristol-Myers Squibb (NYSE: BMY), received a green light from the U.S. Food and Drug Administration (FDA).
Abecma is the “first B-cell maturation antigen (BCMA)-directed chimeric antigen receptor (CAR) T cell immunotherapy for the treatment of adult patients with relapsed or refractory multiple myeloma after four or more prior lines of therapy, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody,” two companies said in a statement.
两家公司在一份声明中说，Abecma是“第一种B细胞成熟抗原(BCMA)导向的嵌合抗原受体(CAR)T细胞免疫疗法，用于治疗成人复发或难治性多发性骨髓瘤患者，此前已经进行了四种或更多的治疗，包括免疫调节剂、蛋白酶体抑制剂和抗CD38单克隆抗体。”
The therapy is a personalized immune cell therapy received as a one-time infusion.
这种疗法是一种个性化的免疫细胞疗法，作为一次性输液接受。
“CAR T cell therapies have shown transformational potential for the treatment of hematologic malignancies, and we, with our partners at bluebird bio, are proud to bring the first CAR T cell therapy to appropriate triple-class exposed patients with relapsed or refractory multiple myeloma, offering the chance for durable response,” said Samit Hirawat, M.D., chief medical officer, Bristol Myers Squibb.
百时美施贵宝(Bristol Myers Squibb)首席医疗官、医学博士萨米特·希拉瓦特(Samit Hirawat)说：“CAR T细胞疗法已显示出治疗血液恶性肿瘤的变革潜力，我们与蓝鸟生物公司的合作伙伴很自豪能将首个CAR T细胞疗法带给适当的三级复发或难治性多发性骨髓瘤患者，提供持久治疗的机会。
Mizuho’s analyst Difei Yang says the FDA approval represents an “important milestone ahead of multiple catalysts” in 2021 for BLUE.
瑞穗(Mizuho)分析师杨迪飞(Difei Yang)表示，FDA的批准代表着2021年蓝色多种催化剂之前的一个重要里程碑。
“This represents an important milestone for bluebird bio in our view, given recent setbacks surrounding the company's gene therapy programs as well as prior delays for Ide-Cel, and also in the context of multiple recent negative FDA decisions in the industry. We believe this approval could give renewed comfort to investors and improve sentiment around the stock,” Yang wrote in a note sent to clients.
在我们看来，这对蓝鸟生物公司来说是一个重要的里程碑，考虑到最近围绕该公司基因治疗计划的挫折以及IDE-CEL之前的延迟，以及FDA最近在该行业做出的多项负面决定的背景下，这对蓝鸟生物公司来说是一个重要的里程碑。我们相信，这一批准可以给投资者带来新的安慰，并改善围绕该股的情绪，“杨致远在发给客户的一份报告中写道。
Mizuho recently upgraded BLUE to “Buy” following a safety update earlier this year around a case of AML in the sickle cell disease gene therapy program, the analyst said. He also raised the price target to $70.00 per share, signaling an upside of over 130% compared to Friday’s closing price.
这位分析师说，今年早些时候，瑞穗(Mizuho)围绕镰状细胞病基因治疗计划中的一例急性髓细胞白血病(AML)病例进行了安全更新，最近将蓝色升级为“购买”(Buy)。他还将目标股价上调至每股70.00美元，表明与上周五收盘价相比上涨了130%以上。
BMO analyst Matthew Luchini also hiked the price target on BLUE to $35.00 per share from the old $31.00. The “Market Perform” rating is unchanged.
蒙特利尔银行分析师马修·卢奇尼(Matthew Luchini)也将Blue的目标价从原来的每股31.00美元上调至35.00美元。“市场表现”评级维持不变。
“We see no surprises in the label and expect focus to shift to commercial as well as label expansion opportunities into larger, earlier line multiple myeloma settings. We increase our target price to $35 from $31 as we increase our probability of success in 4L+ to 100% and update our model for Abecma's $419.5k cost. While Abecma's approval is positive, continued uncertainty around LentiGlobin and bluebird's ability to execute keep us on the sideline,” Luchini said in today's note.
我们在标签上看不到任何令人惊讶的地方，预计重点将转向商业和标签扩展机会，进入更大、更早的多发性骨髓瘤环境。我们将目标价格从31美元提高到35美元，因为我们将4L+的成功几率提高到100%，并根据阿贝玛419.5k美元的成本更新了我们的模型。虽然Abecma的批准是积极的，但围绕LentiGlobin和Bluebird执行能力的持续不确定性让我们保持观望，“卢奇尼在今天的报告中说。
译文内容由第三方软件翻译。