牛牛AI助理已提取核心訊息
On May 7, 2024, Invivyd, Inc., a biopharmaceutical company, announced its plan to submit an Emergency Use Authorization (EUA) application to the U.S. FDA for its investigational monoclonal antibody, PEMGARDA (pemivibart), for the treatment of COVID-19 in moderately to severely immunocompromised individuals. This submission is based on a rapid immunobridging pathway, which leverages serum virus neutralizing antibody titers from prior successful clinical trials. Invivyd anticipates the EUA application to be submitted imminently, with the goal of addressing the critical treatment needs of immunocompromised patients in the U.S. who have limited access to or are not suitable for existing COVID-19 treatments. The company plans to initiate a compact clinical trial focused on confirmatory safety and efficacy following the EUA submission. Despite...Show More
On May 7, 2024, Invivyd, Inc., a biopharmaceutical company, announced its plan to submit an Emergency Use Authorization (EUA) application to the U.S. FDA for its investigational monoclonal antibody, PEMGARDA (pemivibart), for the treatment of COVID-19 in moderately to severely immunocompromised individuals. This submission is based on a rapid immunobridging pathway, which leverages serum virus neutralizing antibody titers from prior successful clinical trials. Invivyd anticipates the EUA application to be submitted imminently, with the goal of addressing the critical treatment needs of immunocompromised patients in the U.S. who have limited access to or are not suitable for existing COVID-19 treatments. The company plans to initiate a compact clinical trial focused on confirmatory safety and efficacy following the EUA submission. Despite this development, Invivyd has left its 2024 net product revenue and year-end cash guidance unchanged, as the potential EUA and commercial dynamics for COVID-19 treatment were not previously accounted for. Further details are expected to be discussed in the upcoming 1Q 2024 results call on May 9, 2024. PEMGARDA, which is currently authorized for pre-exposure prophylaxis (PrEP) of COVID-19 in certain immunocompromised individuals, has shown in vitro neutralizing activity against major SARS-CoV-2 variants. Invivyd's INVYMAB platform has been instrumental in the rapid development of new monoclonal antibodies to address evolving viral threats.
2024年5月7日，生物製藥公司Invivyd, Inc. 宣佈計劃向美國食品藥品管理局提交緊急使用授權（EUA）申請，申請其在研單克隆抗體PEMGARDA（pemivibart），用於治療中度至重度免疫功能低下的人群 COVID-19。本次提交的文件基於快速免疫橋接途徑，該途徑利用了先前成功臨床試驗中的血清病毒中和抗體滴度。Invivyd 預計 EUA 申請將很快提交，目標是滿足美國免疫功能低下患者的關鍵治療需求，這些患者獲得現有 COVID-19 治療的機會有限或不適合接受現有治療。該公司計劃在提交EUA後啓動一項以確認安全性和有效性的緊湊型臨床試驗。儘管取得了這一進展，但Invivyd仍...展開全部
2024年5月7日，生物製藥公司Invivyd, Inc. 宣佈計劃向美國食品藥品管理局提交緊急使用授權（EUA）申請，申請其在研單克隆抗體PEMGARDA（pemivibart），用於治療中度至重度免疫功能低下的人群 COVID-19。本次提交的文件基於快速免疫橋接途徑，該途徑利用了先前成功臨床試驗中的血清病毒中和抗體滴度。Invivyd 預計 EUA 申請將很快提交，目標是滿足美國免疫功能低下患者的關鍵治療需求，這些患者獲得現有 COVID-19 治療的機會有限或不適合接受現有治療。該公司計劃在提交EUA後啓動一項以確認安全性和有效性的緊湊型臨床試驗。儘管取得了這一進展，但Invivyd仍保持其2024年的淨產品收入和年終現金預期不變，因爲此前沒有考慮到 COVID-19 治療的潛在歐盟和商業動態。預計將在即將於2024年5月9日舉行的2024年第一季度業績電話會議上討論更多細節。PEMGARDA目前獲准對某些免疫功能低下的人進行 COVID-19 的暴露前預防（PrEP），它已顯示出對主要SARS-CoV-2變種的體外中和活性。Invivyd 的 INVYMAB 平台在快速開發新的單克隆抗體以應對不斷變化的病毒威脅方面發揮了重要作用。
有用
沒用
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。
以上內容僅用作資訊或教育之目的，不構成與富途相關的任何投資建議。富途竭力但無法保證上述全部內容的真實性、準確性和原創性。
風險及免責聲明
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。
以上內容僅用作資訊或教育之目的，不構成與富途相關的任何投資建議。富途竭力但無法保證上述全部內容的真實性、準確性和原創性。
我知道了
風險及免責聲明
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。
以上內容僅用作資訊或教育之目的，不構成與富途相關的任何投資建議。富途竭力但無法保證上述全部內容的真實性、準確性和原創性。
我知道了