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Invivyd | 8-K: Current report

Invivyd | 8-K:重大事件

SEC announcement ·  01/08 13:00
牛牛AI助手已提取核心信息
On January 8, 2024, Invivyd, Inc., a biotechnology company, filed a Form 8-K with the SEC, reporting the posting of an updated corporate presentation on its website. The presentation, now filed as Exhibit 99.1, details Invivyd's progress and future plans, particularly focusing on VYD222, a monoclonal antibody candidate for the pre-exposure prevention of COVID-19 in immunocompromised adults and adolescents. The company has submitted a request for Emergency Use Authorization (EUA) to the U.S. FDA for VYD222, based on positive initial results from the ongoing CANOPY Phase 3 pivotal clinical trial and its in vitro neutralization activity against major SARS-CoV-2 variants. Invivyd's presentation also outlines the potential market opportunity for VYD222, emphasizing the significant number of immunocompromised individuals who may benefit from the drug. The company is preparing for a potential commercial launch of VYD222 if the EUA is granted, with plans to focus initially on the highest risk immunocompromised populations.
On January 8, 2024, Invivyd, Inc., a biotechnology company, filed a Form 8-K with the SEC, reporting the posting of an updated corporate presentation on its website. The presentation, now filed as Exhibit 99.1, details Invivyd's progress and future plans, particularly focusing on VYD222, a monoclonal antibody candidate for the pre-exposure prevention of COVID-19 in immunocompromised adults and adolescents. The company has submitted a request for Emergency Use Authorization (EUA) to the U.S. FDA for VYD222, based on positive initial results from the ongoing CANOPY Phase 3 pivotal clinical trial and its in vitro neutralization activity against major SARS-CoV-2 variants. Invivyd's presentation also outlines the potential market opportunity for VYD222, emphasizing the significant number of immunocompromised individuals who may benefit from the drug. The company is preparing for a potential commercial launch of VYD222 if the EUA is granted, with plans to focus initially on the highest risk immunocompromised populations.
2024年1月8日,生物技术公司Invivyd, Inc. 向美国证券交易委员会提交了8-K表格,报告了在其网站上发布的最新公司简报。该演示文稿现作为附录 99.1 提交,详细介绍了 Invivyd 的进展和未来计划,特别侧重于 VYD222,一种用于在免疫功能低下的成人和青少年中预防 COVID-19 暴露前预防的单克隆抗体。基于正在进行的CANOPY 3期关键临床试验的积极初步结果及其对主要SARS-CoV-2变体的体外中和活性,该公司已向美国食品药品管理局提交了 VYD222 的紧急使用授权(EUA)申请。Invivyd 的演讲还概述了 VYD222 的潜在市场机会,强调了大量可能从该药物中受益的免疫功能低下的人。如果 EUA 获得批准,该公司正在为 VYD222 的潜在商业发布做准备,并计划最初将重点放在风险最高的免疫功能低下人群上。
2024年1月8日,生物技术公司Invivyd, Inc. 向美国证券交易委员会提交了8-K表格,报告了在其网站上发布的最新公司简报。该演示文稿现作为附录 99.1 提交,详细介绍了 Invivyd 的进展和未来计划,特别侧重于 VYD222,一种用于在免疫功能低下的成人和青少年中预防 COVID-19 暴露前预防的单克隆抗体。基于正在进行的CANOPY 3期关键临床试验的积极初步结果及其对主要SARS-CoV-2变体的体外中和活性,该公司已向美国食品药品管理局提交了 VYD222 的紧急使用授权(EUA)申请。Invivyd 的演讲还概述了 VYD222 的潜在市场机会,强调了大量可能从该药物中受益的免疫功能低下的人。如果 EUA 获得批准,该公司正在为 VYD222 的潜在商业发布做准备,并计划最初将重点放在风险最高的免疫功能低下人群上。

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