Invivyd Emergency Use of PEMGARDA for Pre-exposure Prophylaxis (PrEP) of COVID OKd

 

• PEMGARDA (pemivibart) is authorized in the U.S. for PrEP of COVID-19 in certain adults and adolescents with moderate-to-severe immune compromise
• Emergency use authorization based on positive immunobridging data and on safety data from the CANOPY clinical trial along with ongoing in vitro neutralizing activity against major SARS-CoV-2 variants, including JN.1
• PEMGARDA is the first PrEP monoclonal antibody (mAb) to receive EUA from the U.S. FDA based on a novel, rapid, repeatable immunobridging trial design
• PEMGARDA is the first authorized mAb from Invivyd’s novel technology platform approach designed to address the challenge of rapid viral evolution
• Product availability in the U.S. anticipated imminently
• Estimated cash and cash equivalents of $200.6 million as of December 31, 2023
• In February 2024, the Company sold shares totaling $40.5 million in gross proceeds under its At-the-Market facility further strengthening its balance sheet ahead of PEMGARDA launch
• Conference call today at 4pm ET to discuss the EUA and commercial launch of PEMGARDA

Invivyd will host a conference call and webcast today, Friday, March 22 at 4pm ET. A live audio webcast will be available at https://investors.invivyd.com/. Listeners can register for the webcast via this link. Analysts wishing to participate in the question-and-answer session should use this link. A replay of the webcast will be available in the investor section of the company’s website approximately two hours after the end of the call. Those who plan on participating are advised to join 15 minutes prior to the start time.

https://www.globenewswire.com/news-release/2024/03/22/2851117/0/en/Invivyd-Announces-FDA-Authorization-for-Emergency-Use-of-PEMGARDA-Formerly-VYD222-for-Pre-exposure-Prophylaxis-PrEP-of-COVID-19.html