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Invivyd | 8-K: Current report

Invivyd | 8-K: Current report

Invivyd | 8-K：重大事件
SEC announcement ·  04/04 17:27
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On April 4, 2024, Invivyd, Inc., a biopharmaceutical company, announced the commercial availability of PEMGARDA™ in the United States for pre-exposure prophylaxis (PrEP) of COVID-19 in certain adults and adolescents with moderate-to-severe immune compromise. The announcement follows the emergency use authorization (EUA) granted by the U.S. Food and Drug Administration (FDA) on March 22, 2024. Invivyd also provided net product revenue guidance for 2024, projecting $150 million to $200 million, and expects to end the year with at least $55 million in cash and cash equivalents. A conference call was scheduled for the same day to discuss the launch progress of PEMGARDA. Additionally, Invivyd updated its corporate presentation on its website and filed it as Exhibit 99.2. PEMGARDA, which targets the SARS-CoV-2 spike protein, is available by prescription through a network of authorized specialty distributors. Invivyd's proprietary INVYMAB™ platform combines viral surveillance and predictive modeling with advanced antibody engineering to rapidly generate new monoclonal antibodies to combat evolving viral threats.
On April 4, 2024, Invivyd, Inc., a biopharmaceutical company, announced the commercial availability of PEMGARDA™ in the United States for pre-exposure prophylaxis (PrEP) of COVID-19 in certain adults and adolescents with moderate-to-severe immune compromise. The announcement follows the emergency use authorization (EUA) granted by the U.S. Food and Drug Administration (FDA) on March 22, 2024. Invivyd also provided net product revenue guidance for 2024, projecting $150 million to $200 million, and expects to end the year with at least $55 million in cash and cash equivalents. A conference call was scheduled for the same day to discuss the launch progress of PEMGARDA. Additionally, Invivyd updated its corporate presentation on its website and filed it as Exhibit 99.2. PEMGARDA, which targets the SARS-CoV-2 spike protein, is available by prescription through a network of authorized specialty distributors. Invivyd's proprietary INVYMAB™ platform combines viral surveillance and predictive modeling with advanced antibody engineering to rapidly generate new monoclonal antibodies to combat evolving viral threats.
2024 年 4 月 4 日，生物制药公司 Invivyd, Inc. 宣布 PEMGARDA™ 在美国商业上市，用于某些中度至重度免疫受损的成人和青少年 COVID-19 的暴露前预防 (PrEP)。该公告是在美国食品药品监督管理局（FDA）于2024年3月22日批准的紧急使用授权（EUA）之后发布的。Invivyd还提供了2024年的净产品收入指导，预计为1.5亿至2亿美元，并预计到年底将有至少5500万美元的现金和现金等价物。计划在同一天举行电话会议，讨论PEMGARDA的发布进度。此外，Invivyd在其网站上更新了其公司介绍，并将其作为附录99.2提交。以SARS-CoV-2刺突蛋白为目标的PEMGARDA可通过授权专业分销商网络通过处方获得。Invivyd 专有的 INVYMAB™ 平台将病毒监测和预测建模与先进的抗体工程相结合，可快速生成新的单克隆抗体，以应对不断变化的病毒威胁。
2024 年 4 月 4 日，生物制药公司 Invivyd, Inc. 宣布 PEMGARDA™ 在美国商业上市，用于某些中度至重度免疫受损的成人和青少年 COVID-19 的暴露前预防 (PrEP)。该公告是在美国食品药品监督管理局（FDA）于2024年3月22日批准的紧急使用授权（EUA）之后发布的。Invivyd还提供了2024年的净产品收入指导，预计为1.5亿至2亿美元，并预计到年底将有至少5500万美元的现金和现金等价物。计划在同一天举行电话会议，讨论PEMGARDA的发布进度。此外，Invivyd在其网站上更新了其公司介绍，并将其作为附录99.2提交。以SARS-CoV-2刺突蛋白为目标的PEMGARDA可通过授权专业分销商网络通过处方获得。Invivyd 专有的 INVYMAB™ 平台将病毒监测和预测建模与先进的抗体工程相结合，可快速生成新的单克隆抗体，以应对不断变化的病毒威胁。
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