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Bristol Myers' (BMY) Abecma Gets ODAC Votes for Label Expansion
Zacks Investment Research· 2024-03-18 22:36
FDA审批 - Bristol Myers Squibb (BMY) 和合作伙伴 2seventy bio, Inc (TSVT) 宣布,FDA 肿瘤药物咨询委员会 (ODAC) 投票支持 Abecma (idecabtagene vicleucel) 对于三类药物暴露的复发性或难治性多发性骨髓瘤 (RRMM) 患者的益处/风险概况[1] - Abecma 是一种嵌合抗原受体 (CAR) T细胞疗法,已经适用于接受过四种或更多先前治疗线路的成年患者,包括免疫调节剂、蛋白酶体抑制剂和抗CD38单克隆抗体[2] - ODAC 中的 8 名成员中有 12 名支持 Abecma,称其在早期治疗中对三类药物暴露的多发性骨髓瘤患者展示了有利的益处/风险概况[3] - 基于 KarMMa-3 研究的结果,包括总生存期 (OS) 的关键次要终点,ODAC 对 Abecma 投票持有有利态度[4]
Bristol Myers Squibb Completes Acquisition of PureTech's Founded Entity Karuna Therapeutics for $14 Billion
Businesswire· 2024-03-18 21:52
PureTech Health plc收购Karuna Therapeutics, Inc. - PureTech Health plc宣布完成了其子公司Karuna Therapeutics, Inc.的收购交易,被Bristol Myers Squibb以每股330美元的价格收购,总股权价值约为140亿美元[1] - KarXT有望成为50年来首个为精神分裂症患者提供新治疗机制的药物,对于需要新疗法的数百万精神分裂症患者具有巨大潜力[2] - PureTech在Karuna的持股比例约为2.3%,预计交易完成后将获得约2.93亿美元的总收益,同时保留了在达到某些监管批准里程碑时获得里程碑付款的权利[3]
Bristol Myers Squibb Completes Acquisition of Karuna Therapeutics, Strengthening Neuroscience Portfolio
Businesswire· 2024-03-18 20:44
宝姿斯公司收购Karuna Therapeutics, Inc. - 宝姿斯公司成功完成对Karuna Therapeutics, Inc.的收购,Karuna现在是宝姿斯的全资子公司[1] - 宝姿斯公司通过此次交易获得了KarXT(xanomeline-trospium),一种具有新颖作用机制和差异化疗效和安全性概况的抗精神病药物,以及Karuna的早期和临床前管线[2] 交易影响 - 此次交易预计将对宝姿斯公司2024年的非GAAP摊薄每股收益产生约30美分的稀释效应,主要来自最近完成的新债务发行[3] - 此次交易将作为资产收购进行会计处理,导致约120亿美元的一次性、不可抵扣的收购前研发费用(Acquired IPR&D)支出,预计将影响2024年第一季度和全年的GAAP和非GAAP每股收益约5.93美元[4]
Perspective Therapeutics Announces Clinical Collaboration Agreement with Bristol Myers Squibb to Evaluate [(212)Pb]VMT01 in Combination with Nivolumab in MC1R-Positive Metastatic Melanoma
Newsfilter· 2024-03-18 20:00
Perspective Therapeutics, Inc.与Bristol Myers Squibb合作 - Perspective Therapeutics, Inc.将赞助和资助组合研究,Bristol Myers Squibb将提供nivolumab供研究使用[2] - Perspective Therapeutics, Inc.的首席医疗官Markus Puhlmann表示,对[212Pb]VMT01与nivolumab的联合治疗效果充满潜力[3] 潜在治疗效果 - [212Pb]VMT01与免疫检查点抑制剂的组合在PD-1/CTLA-4耐药的前临床黑色素瘤模型中表现出潜力[4]
FDA Advisory Committee Votes in Favor of Bristol Myers Squibb's and 2seventy bio's Abecma for Triple-Class Exposed Multiple Myeloma in Earlier Lines of Therapy
Businesswire· 2024-03-16 06:27
Abecma CAR T细胞疗法 - 美国食品药品监督管理局(FDA)肿瘤药品咨询委员会(ODAC)对Abecma在三类药物暴露后复发或难治性多发性骨髓瘤患者中表现出有利的风险/效益比例进行了积极投票[1] - Abecma是一种CAR T细胞疗法,通过识别和结合多发性骨髓瘤细胞表面的B细胞成熟抗原(BCMA),导致CAR T细胞增殖、细胞因子分泌和随后对表达BCMA的细胞的溶解杀伤[4] - Abecma已在日本和瑞士获得批准,用于接受至少两种先前疗法(包括免疫调节剂、蛋白酶体抑制剂和抗CD38抗体)的复发和/或难治性多发性骨髓瘤患者,使其成为首个获得批准用于早期疗法线的CAR T细胞疗法[3] ABECMA治疗注意事项 - ABECMA治疗可能导致患者出现继发性恶性肿瘤,建议终身监测[30][31] - ABECMA治疗后8周内患者可能出现神经事件,需避免驾驶和操作危险机械[31] - ABECMA治疗可能引起的常见非实验室不良反应包括CRS、感染、疲劳、肌肉骨骼疼痛等[32]
Bristol Myers (BMY) Gets FDA Nod for Breyanzi's Label Expansion
Zacks Investment Research· 2024-03-15 22:16
Bristol Myers Squibb (BMY) announced that the FDA has granted accelerated approval to chimeric antigen receptor (CAR) T cell therapy, Breyanzi (lisocabtagene maraleucel), for one more indication.The approval was granted for the treatment of adult patients with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who have received at least two prior lines of therapy, including a Bruton tyrosine kinase (BTK) inhibitor and a B-cell lymphoma 2 (BCL-2) inhibitor. The acce ...
U.S. FDA Approves Bristol Myers Squibb's Breyanzi® as the First and Only CAR T Cell Therapy for Adults with Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL)
Businesswire· 2024-03-15 09:35
Bristol Myers Squibb宣布FDA批准Breyanzi用于治疗CLL/SLL - Bristol Myers Squibb宣布FDA已加速批准Breyanzi用于治疗成人复发性或难治性慢性淋巴细胞白血病(CLL)或小淋巴细胞淋巴瘤(SLL)[1] - Breyanzi是第一个获得批准用于复发性或难治性CLL或SLL的CAR T细胞疗法,为患者提供个性化选择[2] - TRANSCEND CLL 004研究显示,Breyanzi治疗的CR率为20%,响应持续时间较长[3] FDA批准liso-cel用于CLL和SLL治疗 - FDA批准liso-cel在复发性或难治性CLL和SLL中的使用是一项重大突破,有望为患者提供完全和持久的缓解[4] BREYANZI治疗CLL/SLL患者的神经毒性反应 - BREYANZI治疗CLL/SLL患者时,46%出现CAR T细胞相关的神经毒性反应[31] - 神经毒性反应中最常见的包括脑病、震颤、失语症、头痛、眩晕和谵妄[32] - 对于CRS和神经毒性反应,需要在BREYANZI输注后至少监测7天[33] - 在BREYANZI输注后至少监测4周,及时治疗CRS和神经毒性反应[34]
Get Paid To Wait: 13 Potential Dividend Opportunities
Seeking Alpha· 2024-03-15 00:15
SIphotography/iStock via Getty Images Get Paid To Wait The Efficient Market Hypothesis tells us that share prices reflect all available information and therefore it is effectively impossible to consistently generate alpha. Academics have long accepted this theory and provided sufficient data to prove that it's true. While there certainly are proponents of the theory, it also has its critics. Many famous investors disagree with the hypothesis and have track records that prove it cannot be true. Regardles ...
Bristol-Myers Squibb Company (BMY) Barclays 26th Annual Global Healthcare Conference (Transcript)
2024-03-14 23:02
产品展示 - 公司对Abecma的临床益处感到非常自信,已在日本获得批准,并在欧洲和瑞士取得成功[5] - Abecma在早期治疗中展现出了临床益处,通过KarMMa-3试验的结果得以证实[6] - 公司对Abecma在长期商业竞争力持乐观态度,特别强调了其在早期治疗中的优势[10] - 公司相信Abecma的安全性特点将在早期治疗中发挥重要作用,与竞争对手相比具有优势[12] 新产品和技术研发 - 公司对LAG-3项目的结果感到兴奋,计划在年底前启动第三阶段研究[14] - 通过LAG-3项目,公司确定了20%至30%的患者群体将从LAG-3加PD-1加化疗中获益[14] - 公司在肺癌领域持续扩大产品组合,致力于满足不同患者的治疗需求[19] 市场扩张和并购 - RayzeBio的收购为BMS带来了资产、IND引擎和制造能力,将有助于细胞疗法平台的发展[57] - BMS对于SystImmune的合作机会感到兴奋,这将有助于公司在肺癌和乳腺癌领域进一步发展[58]
Bristol Myers Squibb Company (BMY) is Attracting Investor Attention: Here is What You Should Know
Zacks Investment Research· 2024-03-14 22:06
Bristol Myers Squibb (BMY) has recently been on Zacks.com's list of the most searched stocks. Therefore, you might want to consider some of the key factors that could influence the stock's performance in the near future.Shares of this biopharmaceutical company have returned +7.7% over the past month versus the Zacks S&P 500 composite's +4.4% change. The Zacks Medical - Biomedical and Genetics industry, to which Bristol Myers belongs, has gained 4% over this period. Now the key question is: Where could the s ...