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CRISPR Therapeutics | 8-K: Current report

CRISPR Therapeutics | 8-K:重大事件

SEC announcement ·  02/13 19:34
牛牛AI助理已提取核心訊息
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與Vertex Pharmicals Incorporated合作,其基因編輯療法CASGEVY™(exa-gamglogene autotemcel [exa-cel])已獲得歐盟委員會的有條件上市許可。該授權於2024年2月13日宣佈,允許在沒有匹配幹細胞捐贈者的情況下,治療12歲及以上的嚴重鐮狀細胞病和輸血依賴性β地中海貧血患者。有條件的上市許可是爲滿足重大未滿足的醫療需求的治療簽發的,並且根據持續的數據審查,每年都會續訂。
CRISPR Therapeutics AG與Vertex Pharmicals Incorporated合作,其基因編輯療法CASGEVY™(exa-gamglogene autotemcel [exa-cel])已獲得歐盟委員會的有條件上市許可。該授權於2024年2月13日宣佈,允許在沒有匹配幹細胞捐贈者的情況下,治療12歲及以上的嚴重鐮狀細胞病和輸血依賴性β地中海貧血患者。有條件的上市許可是爲滿足重大未滿足的醫療需求的治療簽發的,並且根據持續的數據審查,每年都會續訂。

譯文內容由第三人軟體翻譯。


牛牛AI助手部分由第三方人工智慧模型基於資訊內容自動產生,只对除中国内地以外的地区提供。


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