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Invivyd | 8-K: Current report

Invivyd | 8-K: Current report

Invivyd | 8-K:重大事件
美股SEC公告 ·  09/03 19:11

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On September 3, 2024, Invivyd, Inc., a biopharmaceutical company, announced the continued neutralizing activity of its investigational monoclonal antibody, PEMGARDA™ (pemivibart), against dominant SARS-CoV-2 variants KP.3.1.1 and LB.1, as well as other variants of interest. The announcement was made through a press release and filed with the SEC as part of a Form 8-K report. The Center for Disease Control (CDC) reported that KP.3.1.1 is currently the only major variant increasing in proportionality across the U.S. Invivyd's industrial virology effort, which includes independent third-party pseudoviral testing, confirmed that these variants are susceptible to pemivibart. The company has submitted the data to the FDA for updates to the PEMGARDA Healthcare Providers Fact Sheet. Invivyd also highlighted the potential of...Show More
On September 3, 2024, Invivyd, Inc., a biopharmaceutical company, announced the continued neutralizing activity of its investigational monoclonal antibody, PEMGARDA™ (pemivibart), against dominant SARS-CoV-2 variants KP.3.1.1 and LB.1, as well as other variants of interest. The announcement was made through a press release and filed with the SEC as part of a Form 8-K report. The Center for Disease Control (CDC) reported that KP.3.1.1 is currently the only major variant increasing in proportionality across the U.S. Invivyd's industrial virology effort, which includes independent third-party pseudoviral testing, confirmed that these variants are susceptible to pemivibart. The company has submitted the data to the FDA for updates to the PEMGARDA Healthcare Providers Fact Sheet. Invivyd also highlighted the potential of another pipeline candidate, VYD2311, which shows promising neutralization potency against the same viruses. PEMGARDA, which targets the SARS-CoV-2 spike protein, has been authorized for emergency use by the FDA for pre-exposure prophylaxis in certain immunocompromised individuals. Invivyd's Chief Scientific Officer and Chairman of the Board emphasized the robustness of the data and the importance of reliable antibody neutralization assessments. The company's INVYMAB™ platform is designed to rapidly generate new monoclonal antibodies to address evolving viral threats.
2024年9月3日,生物製藥公司Invivyd公司宣佈其研究用單克隆抗體PEMGARDA™(pemivibart)繼續對主要SARS-CoV-2變體KP.3.1.1和Lb.1,以及其他感興趣的變體具有中和活性。該公告通過新聞稿發佈,並作爲8-k報告的一部分提交給美國證券交易委員會。疾病控制中心(CDC)報告稱,KP.3.1.1目前是美國唯一一個在整體比例上增加的重要變體。Invivyd的工業病毒學工作,包括獨立第三方僞病毒測試,確認這些變體對pemivibart具有敏感性。公司已將數據提交給FDA,用於更新PEMGARDA醫護人員說明書。Invivyd還強調了另一候選藥物VYD2311的潛力,...展開全部
2024年9月3日,生物製藥公司Invivyd公司宣佈其研究用單克隆抗體PEMGARDA™(pemivibart)繼續對主要SARS-CoV-2變體KP.3.1.1和Lb.1,以及其他感興趣的變體具有中和活性。該公告通過新聞稿發佈,並作爲8-k報告的一部分提交給美國證券交易委員會。疾病控制中心(CDC)報告稱,KP.3.1.1目前是美國唯一一個在整體比例上增加的重要變體。Invivyd的工業病毒學工作,包括獨立第三方僞病毒測試,確認這些變體對pemivibart具有敏感性。公司已將數據提交給FDA,用於更新PEMGARDA醫護人員說明書。Invivyd還強調了另一候選藥物VYD2311的潛力,該藥物顯示出對同一病毒的中和效能。PEMGARDA以瞄準SARS-CoV-2尖刺蛋白而著稱,已獲得FDA授權在特定免疫受損個體中預防接觸前暴露。Invivyd的首席科學官兼董事長強調了數據的可靠性和可靠的抗體中和評估的重要性。該公司的INVYMAB™平台旨在快速生成新的單克隆抗體,以應對不斷演變的病毒威脅。
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