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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宣佈其研究性單克隆抗體PEMGARDA™(pemivibart)對主要的SARS-CoV-2變異株KP.3.1.1和Lb.1以及其他感興趣的變異株持續呈中和活性。該公告通過新聞稿發佈,並作爲8-k報告的一部分提交給證券交易委員會(SEC)。美國疾病控制中心(CDC)報告稱,KP.3.1.1目前是唯一在美國比例增加的主要變異株。Invivyd的工業病毒學工作包括獨立第三方假病毒測試,確認這些變異株對pemivibart具有敏感性。該公司已向FDA提交數據,以更新PEMGARDA醫療服務提供者信息表。Invivyd還強調了另一種研發候選藥VYD2311...展開全部
2024年9月3日,生物製藥公司Invivyd宣佈其研究性單克隆抗體PEMGARDA™(pemivibart)對主要的SARS-CoV-2變異株KP.3.1.1和Lb.1以及其他感興趣的變異株持續呈中和活性。該公告通過新聞稿發佈,並作爲8-k報告的一部分提交給證券交易委員會(SEC)。美國疾病控制中心(CDC)報告稱,KP.3.1.1目前是唯一在美國比例增加的主要變異株。Invivyd的工業病毒學工作包括獨立第三方假病毒測試,確認這些變異株對pemivibart具有敏感性。該公司已向FDA提交數據,以更新PEMGARDA醫療服務提供者信息表。Invivyd還強調了另一種研發候選藥VYD2311的潛力,該藥顯示出對相同病毒的中和效力有希望。PEMGARDA以瞄準SARS-CoV-2尖刺蛋白而聞名,已被FDA授權用於特定免疫受損個體的預暴露預防。Invivyd的首席科學官和董事會主席強調了數據的健壯性以及可靠的抗體中和評估的重要性。該公司的INVYMAB™平台旨在迅速生成新的單克隆抗體,以應對不斷髮展的病毒威脅。

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