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Invivyd | 8-K: Current report

Invivyd | 8-K: Current report

Invivyd | 8-K:重大事件
SEC announcement ·  03/28 19:09
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On March 28, 2024, Invivyd, Inc., a biopharmaceutical company, announced its financial results for the year ended December 31, 2023, and highlighted recent business achievements. The announcement was made through a press release which was furnished as Exhibit 99.1 to the company's Current Report on Form 8-K filed with the SEC. Invivyd reported significant progress, including the emergency use authorization (EUA) granted by the FDA for PEMGARDA, a monoclonal antibody for pre-exposure prophylaxis of COVID-19 in certain immunocompromised adults and adolescents. The company anticipates immediate availability of PEMGARDA in the U.S. and is preparing for a full commercial launch. Invivyd leveraged its INVYMAB platform to design VYD2311, the next anti-SARS-CoV-2 monoclonal antibody candidate. Financially, Invivyd ended the year with $200.6 million in...Show More
On March 28, 2024, Invivyd, Inc., a biopharmaceutical company, announced its financial results for the year ended December 31, 2023, and highlighted recent business achievements. The announcement was made through a press release which was furnished as Exhibit 99.1 to the company's Current Report on Form 8-K filed with the SEC. Invivyd reported significant progress, including the emergency use authorization (EUA) granted by the FDA for PEMGARDA, a monoclonal antibody for pre-exposure prophylaxis of COVID-19 in certain immunocompromised adults and adolescents. The company anticipates immediate availability of PEMGARDA in the U.S. and is preparing for a full commercial launch. Invivyd leveraged its INVYMAB platform to design VYD2311, the next anti-SARS-CoV-2 monoclonal antibody candidate. Financially, Invivyd ended the year with $200.6 million in cash and cash equivalents and raised an additional $40.5 million in February 2024 through its At-the-Market facility. The company expects its funds to cover expenses into the fourth quarter of 2024. R&D expenses decreased to $163.6 million in 2023 from $183.6 million in 2022, while SG&A expenses increased slightly to $49.1 million. The net loss for the year was $198.6 million, with a basic and diluted net loss per share of $1.81. Invivyd's CEO, Dave Hering, expressed pride in the company's achievements and focus on executing the commercial launch plan for PEMGARDA.
2024年3月28日,生物制药公司Invivyd, Inc. 公布了截至2023年12月31日的年度财务业绩,并重点介绍了最近的业务成就。该公告是通过一份新闻稿发布的,该新闻稿作为该公司向美国证券交易委员会提交的8-K表最新报告的附录99.1提供。Invivyd 报告了重大进展,包括美国食品药品管理局授予 PEMGARDA 的紧急使用授权 (EUA),这是一种单克隆抗体,用于对某些免疫功能低下的成人和青少年进行 COVID-19 的暴露前预防。该公司预计PEMGARDA将立即在美国上市,并正在为全面的商业发布做准备。Invivyd 利用其 INVYMAB 平台设计了 VYD2311,这是下一个...展开全部
2024年3月28日,生物制药公司Invivyd, Inc. 公布了截至2023年12月31日的年度财务业绩,并重点介绍了最近的业务成就。该公告是通过一份新闻稿发布的,该新闻稿作为该公司向美国证券交易委员会提交的8-K表最新报告的附录99.1提供。Invivyd 报告了重大进展,包括美国食品药品管理局授予 PEMGARDA 的紧急使用授权 (EUA),这是一种单克隆抗体,用于对某些免疫功能低下的成人和青少年进行 COVID-19 的暴露前预防。该公司预计PEMGARDA将立即在美国上市,并正在为全面的商业发布做准备。Invivyd 利用其 INVYMAB 平台设计了 VYD2311,这是下一个抗SARS-CoV-2单克隆抗体候选药物。财务方面,Invivyd在年底获得了2.06亿美元的现金及现金等价物,并于2024年2月通过其市场融资又筹集了4,050万美元。该公司预计,其资金将用于支付2024年第四季度的费用。研发费用从2022年的1.836亿美元下降至2023年的1.636亿美元,而销售和并购支出略有增加至4,910万美元。该年度的净亏损为1.986亿美元,基本和摊薄后的每股净亏损为1.81美元。Invivyd的首席执行官戴夫·赫林对公司取得的成就表示自豪,并专注于执行PEMGARDA的商业发布计划。

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