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CRISPR Therapeutics | 8-K: Current report

CRISPR Therapeutics | 8-K:重大事件

美股sec公告 ·  02/13 06:34
Moomoo AI 已提取核心信息
CRISPR Therapeutics AG, in collaboration with Vertex Pharmaceuticals Incorporated, has received conditional marketing authorization from the European Commission for its gene-edited therapy, CASGEVY™ (exagamglogene autotemcel [exa-cel]). Announced on February 13, 2024, the authorization allows the treatment of patients 12 years and older with severe sickle cell disease and transfusion-dependent beta thalassemia, where no matched stem cell donor is available. Conditional marketing authorizations are issued for treatments that address significant unmet medical needs and are subject to annual renewal based on ongoing data review.
CRISPR Therapeutics AG, in collaboration with Vertex Pharmaceuticals Incorporated, has received conditional marketing authorization from the European Commission for its gene-edited therapy, CASGEVY™ (exagamglogene autotemcel [exa-cel]). Announced on February 13, 2024, the authorization allows the treatment of patients 12 years and older with severe sickle cell disease and transfusion-dependent beta thalassemia, where no matched stem cell donor is available. Conditional marketing authorizations are issued for treatments that address significant unmet medical needs and are subject to annual renewal based on ongoing data review.
CRISPR Therapeutics AG与Vertex Pharmicals Incorporated合作,其基因编辑疗法CASGEVY™(exa-gamglogene autotemcel [exa-cel])已获得欧盟委员会的有条件上市许可。该授权于2024年2月13日宣布,允许在没有匹配干细胞捐赠者的情况下,治疗12岁及以上的严重镰状细胞病和输血依赖性β地中海贫血患者。有条件的上市许可是为满足重大未满足的医疗需求的治疗签发的,并且根据持续的数据审查,每年都会续订。
CRISPR Therapeutics AG与Vertex Pharmicals Incorporated合作,其基因编辑疗法CASGEVY™(exa-gamglogene autotemcel [exa-cel])已获得欧盟委员会的有条件上市许可。该授权于2024年2月13日宣布,允许在没有匹配干细胞捐赠者的情况下,治疗12岁及以上的严重镰状细胞病和输血依赖性β地中海贫血患者。有条件的上市许可是为满足重大未满足的医疗需求的治疗签发的,并且根据持续的数据审查,每年都会续订。
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