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On January 3, 2024, Invivyd, Inc., a biopharmaceutical company, announced the submission of a request for Emergency Use Authorization (EUA) to the U.S. Food and Drug Administration (FDA) for its monoclonal antibody candidate, VYD222, aimed at the pre-exposure prevention of COVID-19 in immunocompromised adults and adolescents. The EUA request is supported by positive initial results from the ongoing CANOPY Phase 3 pivotal clinical trial and in vitro neutralization activity against current SARS-CoV-2 variants, including the rapidly spreading JN.1 variant. Invivyd's CEO, Dave Hering, expressed confidence in VYD222's continued neutralization activity and the company's strategic approach to targeting conserved epitopes to keep pace with viral evolution. The company is also preparing for a potential commercial launch of VYD222, should the EUA...Show More
On January 3, 2024, Invivyd, Inc., a biopharmaceutical company, announced the submission of a request for Emergency Use Authorization (EUA) to the U.S. Food and Drug Administration (FDA) for its monoclonal antibody candidate, VYD222, aimed at the pre-exposure prevention of COVID-19 in immunocompromised adults and adolescents. The EUA request is supported by positive initial results from the ongoing CANOPY Phase 3 pivotal clinical trial and in vitro neutralization activity against current SARS-CoV-2 variants, including the rapidly spreading JN.1 variant. Invivyd's CEO, Dave Hering, expressed confidence in VYD222's continued neutralization activity and the company's strategic approach to targeting conserved epitopes to keep pace with viral evolution. The company is also preparing for a potential commercial launch of VYD222, should the EUA be granted. The CANOPY trial, which completed enrollment in November 2023, is evaluating VYD222's efficacy in preventing symptomatic COVID-19 and has shown promising early signs of clinical protection and a favorable safety profile. VYD222 has demonstrated in vitro potency against various SARS-CoV-2 variants, and if authorized, Invivyd plans to make it commercially available shortly thereafter.
2024 年 1 月 3 日，生物製藥公司 Invivyd, Inc. 宣佈向美國食品藥品監督管理局 (FDA) 提交了其單克隆抗體候選物 VYD222 的緊急使用授權 (EUA) 申請，該單克隆抗體候選藥物旨在預防免疫功能低下的成人和青少年 COVID-19 的暴露前預防。EUA的請求得到了正在進行的CANOPY 3期關鍵臨床試驗的積極初步結果以及針對當前SARS-CoV-2變體（包括快速傳播的JN.1變體）的體外中和活性的支持。Invivyd 的首席執行官戴夫·赫林對 VYD222 的持續中和活動以及該公司針對保守表位以跟上病毒進化的步伐的戰略方針表示了信心。如果獲得歐盟許可，該公司還在爲...展開全部
2024 年 1 月 3 日，生物製藥公司 Invivyd, Inc. 宣佈向美國食品藥品監督管理局 (FDA) 提交了其單克隆抗體候選物 VYD222 的緊急使用授權 (EUA) 申請，該單克隆抗體候選藥物旨在預防免疫功能低下的成人和青少年 COVID-19 的暴露前預防。EUA的請求得到了正在進行的CANOPY 3期關鍵臨床試驗的積極初步結果以及針對當前SARS-CoV-2變體（包括快速傳播的JN.1變體）的體外中和活性的支持。Invivyd 的首席執行官戴夫·赫林對 VYD222 的持續中和活動以及該公司針對保守表位以跟上病毒進化的步伐的戰略方針表示了信心。如果獲得歐盟許可，該公司還在爲可能的 VYD222 商業發佈做準備。CANOPY 試驗於 2023 年 11 月完成註冊，正在評估 VYD222 在預防有症狀的 COVID-19 方面的功效，並顯示出令人鼓舞的臨床保護早期跡象和良好的安全性。VYD222 已顯示出對抗各種 SARS-CoV-2 變體的體外效力，如果獲得授權，Invivyd 計劃在此後不久將其上市。
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