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Invivyd | 8-K: Current report

Invivyd | 8-K: Current report

Invivyd | 8-K:重大事件
SEC announcement ·  04/05 05:27
牛牛AI助理已提取核心訊息
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,生物製藥公司 Invivyd, Inc. 宣佈 PEMGARDA™ 在美國商業上市,用於某些中度至重度免疫受損的成人和青少年 COVID-19 的暴露前預防 (PrEP)。該公告是在美國食品藥品監督管理局(FDA)於2024年3月22日批准的緊急使用授權(EUA)之後發佈的。Invivyd還提供了2024年的淨產品收入指導,預計爲1.5億至2億美元,並預計到年底將有至少5500萬美元的現金和現金等價物。計劃在同一天舉行電話會議,討論PEMGARDA的發佈進度。此外,Invivyd在其網站上更新了其公司介紹,並將其作爲附錄99.2提交。以SARS-CoV-2刺突蛋白爲目標的PEMGARDA可通過授權專業分銷商網絡通過處方獲得。Invivyd 專有的 INVYMAB™ 平台將病毒監測和預測建模與先進的抗體工程相結合,可快速生成新的單克隆抗體,以應對不斷變化的病毒威脅。
2024 年 4 月 4 日,生物製藥公司 Invivyd, Inc. 宣佈 PEMGARDA™ 在美國商業上市,用於某些中度至重度免疫受損的成人和青少年 COVID-19 的暴露前預防 (PrEP)。該公告是在美國食品藥品監督管理局(FDA)於2024年3月22日批准的緊急使用授權(EUA)之後發佈的。Invivyd還提供了2024年的淨產品收入指導,預計爲1.5億至2億美元,並預計到年底將有至少5500萬美元的現金和現金等價物。計劃在同一天舉行電話會議,討論PEMGARDA的發佈進度。此外,Invivyd在其網站上更新了其公司介紹,並將其作爲附錄99.2提交。以SARS-CoV-2刺突蛋白爲目標的PEMGARDA可通過授權專業分銷商網絡通過處方獲得。Invivyd 專有的 INVYMAB™ 平台將病毒監測和預測建模與先進的抗體工程相結合,可快速生成新的單克隆抗體,以應對不斷變化的病毒威脅。

譯文內容由第三人軟體翻譯。


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