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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 07:11

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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,生物制药公司Invivyd宣布其研究性单克隆抗体PEMGARDA™(pemivibart)对SARS-CoV-2变种KP.3.1.1和Lb.1以及其他相关病毒具有持续的中和活性。这一公告通过新闻稿发布,并作为8-k报告的一部分提交给美国证券交易委员会(SEC)。疾病控制中心(CDC)表示,KP.3.1.1目前是美国唯一一种比例增长的重要变种。Invivyd的工业病毒学研究,包括独立第三方假病毒测试,证实这些变种对pemivibart敏感。该公司已向美国食品药品监督管理局(FDA)提交了数据,以更新PEMGARDA医疗服务提供者说明书。Invivyd还强调了另一个研究候选药物...展开全部
2024年9月3日,生物制药公司Invivyd宣布其研究性单克隆抗体PEMGARDA™(pemivibart)对SARS-CoV-2变种KP.3.1.1和Lb.1以及其他相关病毒具有持续的中和活性。这一公告通过新闻稿发布,并作为8-k报告的一部分提交给美国证券交易委员会(SEC)。疾病控制中心(CDC)表示,KP.3.1.1目前是美国唯一一种比例增长的重要变种。Invivyd的工业病毒学研究,包括独立第三方假病毒测试,证实这些变种对pemivibart敏感。该公司已向美国食品药品监督管理局(FDA)提交了数据,以更新PEMGARDA医疗服务提供者说明书。Invivyd还强调了另一个研究候选药物VYD2311的潜力,该药物显示出对相同病毒的中和效果。PEMGARDA针对SARS-CoV-2的刺突蛋白并已被FDA授权用于某些免疫受损个体的预防性应急使用。Invivyd的首席科学官兼董事会主席强调了数据的稳健性和可靠的抗体中和评估的重要性。该公司的INVYMAB™平台旨在快速生成新的单克隆抗体,以应对不断演变的病毒威胁。
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