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百时美施贵宝-270 Bio-Halt 3期试验用于新诊断骨髓瘤患者的Abecma,加快了盈利途径

Bristol Myers-2seventy Bio Halt Phase 3 Trial For Abecma In Newly Diagnosed Myeloma Patients, Speeds Path To Profitability

benzinga 等信源发布 2024-09-25 11:56

可切换为仅中文


2seventy bio, Inc TSVT and its partner Bristol Myers Squibb & Co BMY, will discontinue enrollment in its ongoing Phase 3 KarMMa-9 study of Abecma (idecabtagene vicleucel; ide-cel) with lenalidomide maintenance versus lenalidomide maintenance alone for newly diagnosed multiple myeloma (NDMM) who have suboptimal response to autologous stem cell transplant..

2seventy bio,Inc TSVT及其合作伙伴百时美施贵宝公司(Bristol-Myers Squibb&Co BMY)将停止正在进行的Abecma(idecabtagene Vicluecel;ide cel)的3期KarMMa-9研究,来那度胺维持治疗与来那度胺单独维持治疗对自体干细胞移植反应不佳的新诊断多发性骨髓瘤(NDMM)。。

'Consistent with our focus on capital allocation and creating value for all stakeholders, we anticipate this decision will conserve over $80 million in near-term expenditures and accelerate our path to breakeven in 2025,' said Chip Baird, CEO of 2seventy bio.

2seventy bio首席执行官奇普·贝尔德(ChipBaird)说,与我们专注于资本配置和为所有利益相关者创造价值的目标一致,我们预计这一决定将节省8000多万美元的短期支出,并加速我们在2025年实现盈亏平衡。

Also Read: FDA Approves Bristol-Myers/2seventy Bio's Abecma For Earlier Use In Pretreated Blood Cancer Patients With Updated Boxed Warning On Secondary Cancer.

另请阅读:FDA批准Bristol-Myers/2seventy Bio的Abecma早期用于预处理的血癌患者,并更新了继发性癌症的盒装警告。

2seventy also reported continued positive momentum in Abecma's expected return to growth in the earlier line setting following the FDA's approval in April 2024.

2seventy还报告称,在2024年4月FDA批准后,Abecma预计将恢复早期的增长势头。

The company expects third-quarter Abecma U.S. revenue growth of approximately 30% from second-quarter revenue of $54 million. Demand, as measured by new patients undergoing apheresis in the third quarter, is also expected to reflect double-digit growth compared to the second quarter of 2024.

该公司预计第三季度Abecma U。S、 第二季度收入为5400万美元,收入增长约30%。与2024年第二季度相比,第三季度接受单采血液的新患者的需求预计也将出现两位数的增长。

William Blair says while expectations for Abecma are generally low for investors at this point, the ability to maximize the opportunity in the current label would offset concerns about the fixed costs of the cell therapy franchise.

2seventy bio and BMS share equally in all profits and losses related to the development, manufacturing, and commercialization of Abecma in the U.S.

2seventy bio和BMS在与Abecma在美国的开发、制造和商业化有关的所有损益中平均分配。

Overall, the announcement suggests moving CAR-T therapies into the earliest lines of treatment may have headwinds given the strong current standard of care. Therefore, we think thoughtful trial designs that reflect the changing standard of care will have the greatest potential of maximizing the CAR-T total addressable market.'.

总体而言,该公告表明,鉴于目前强大的护理标准,将CAR-T疗法转移到最早的治疗线可能会产生阻力。因此,我们认为反映不断变化的护理标准的深思熟虑的试验设计将具有最大限度地扩大CAR-T总可寻址市场的潜力。”。

Recently, Novo Nordisk A/S NVO acquired the Hemophilia A program and rights to 2seventy's in vivo gene editing technology outside of oncology and gene editing for autologous or allogeneic cell therapies of immune cells for autoimmune disease.

最近,诺和诺德A/S NVO收购了血友病A计划,并获得了2seventy在肿瘤学和基因编辑之外的体内基因编辑技术的权利,用于自体免疫疾病免疫细胞的自体或同种异体细胞疗法。

2seventy bio will focus exclusively on the commercialization and continued development of Abecma.

2seventy bio将专注于Abecma的商业化和持续发展。

Price Action: TSVT stock is down 7.65% at $4.41, and BMY stock is down 2.90% at $49.47 at last check Wednesday.

价格走势:TSVT股价下跌7.65%,至4.41美元,BMY股价下跌2.90%,至49.47美元。

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