登录

美国食品药品监督管理局解除对癌症试验的临床搁置后,Iovance股价上涨

Iovance stock rises after FDA lifts clinical hold on lung cancer trial

seekingalpha 2024-03-04 20:04 翻译由动脉网AI生成,点击反馈

可切换为仅中文


Grandbrothers/iStock Editorial via Getty Images Shares of Iovance Biotherapeutics (NASDAQ:IOVA) gained 8% premarket on Monday after it said that the U.S. Food and Drug Administration (FDA) lifted a partial clinical hold placed on a Phase 2 study evaluating its experimental lung cancer cell therapy, LN-145.

Grandbrothers/iStock通过Getty Images发表社论Iovance Biotherapeutics(纳斯达克:IOVA)的股票周一上市前上涨8%,此前该公司表示,美国食品和药物管理局(FDA)解除了对其实验性肺癌细胞治疗LN-145的2期研究的部分临床搁置。

Back in December, the U.S. drug regulator placed Iovance’s (IOVA) Phase 2 IOV-LUN-202 trial for LN-145 on clinical hold following the death of a trial participant. The study was designed to evaluate LN-145, a tumor-infiltrating lymphocyte (TIL) therapy, as a late-line option for certain patients with non-small cell lung cancer (NSCLC).

早在12月,美国药物监管机构在一名试验参与者死亡后,将Iovance(IOVA)针对LN-145的第二阶段IOV-LUN-202试验置于临床搁置状态。该研究旨在评估LN-145(一种肿瘤浸润淋巴细胞(TIL)疗法)作为某些非小细胞肺癌(NSCLC)患者的晚期选择。

Since then, the biotechnology company has worked with the FDA and an independent data monitoring committee to develop additional safety measures and monitoring. Upon reviewing this proposal, the FDA has cleared Iovance (IOVA) to resume patient enrollment in IOV-LUN-202. .

从那时起,该生物技术公司与FDA和一个独立的数据监测委员会合作,制定额外的安全措施和监测。在审查该提案后,FDA已批准Iovance(IOVA)恢复IOV-LUN-202中的患者登记。

Iovance (IOVA) expects to complete enrollment of approximately 120 patients in the IOV-LUN-202 registrational cohorts in 2025. Preliminary data from the IOV-LUN-202 trial supported the potential benefit of one-time TIL therapy, including the opportunity for more durable responses than available second line chemotherapies.

Iovance(IOVA)预计在2025年完成IOV-LUN-202登记队列中约120名患者的登记。来自IOV-LUN-202试验的初步数据支持一次性TIL治疗的潜在益处,包括比可用的二线化疗更持久的反应的机会。

More on Iovance Biotherapeutics Iovance Biotherapeutics, Inc. (IOVA) Q4 2023 Earnings Call Transcript A Close Look At Iovance Biotherapeutics' Accelerated Approval Iovance Biotherapeutics: Amtagvi's Pioneering Approval Sets New Standards In Melanoma Iovance Biotherapeutics Q4 2023 Earnings Preview Iovance rallies nearly 40% on FDA approval, stock offering .

有关Iovance Biotherapeutics的更多信息Iovance Biotherapeutics,Inc.(IOVA)2023年第四季度收益通话记录仔细查看Iovance Biotherapeutics的加速批准Iovance Biotherapeutics:Amtagvi的开创性批准为黑色素瘤设定了新标准Iovance Biotherapeutics 2023年第四季度收益预览Iovance在FDA批准,股票发行后上涨近40%。

推荐阅读

120多名医生参加了关于介入骨科和非手术治疗进展的会议

Medgate Today 2024-07-13 20:52

北京大学第三医院4个牵头项目荣获2023年北京医学科技奖

北京大学医学部 2024-07-13 20:23

与NeoRAS野生型转移性癌症相关的临床特征——SCRUM-Japan GOZILA亚研究

Nature 2024-07-13 19:13

seekingalpha

412篇

最近内容 查看更多

2024年迄今为止表现最好的10只生物技术股

2024-03-07

Creative Medical股价上涨18%,脆性1型糖尿病候选疗法获授予孤儿药称号

2024-03-06

Cyclacel Pharmaceuticals获得290万美元的研发税收抵免

2024-03-06

产业链接查看更多