Business
Invivyd Reports Full Year 2023 Financial Results and Recent Business Highlights
Received emergency use authorization for PEMGARDA™, a monoclonal antibody (mAb) authorized in the U.S. for pre-exposure prophylaxis (PrEP) of COVID-19 in
About this update from Invivyd, Inc.
[{"type":"text","content":"Received emergency use authorization for PEMGARDA™, a monoclonal antibody (mAb) authorized in the U.S. for pre-exposure prophylaxis (PrEP) of COVID-19 in certain adults and adolescents with moderate-to-severe immune compromise PEMGARDA product availability in the U.S. anticipated imminentlyPEMGARDA is the first authorized mAb from Invivyd’s INVYMAB™ platform approach designed to address the challenge of rapid viral evolutionLeveraged INVYMAB platform approach to design VYD2311, the company’s next anticipated SARS-CoV-2 candidate Cash and cash equivalents of $200.6 million as of December 31, 2023In 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 WALTHAM, Mass., March 28, 2024 (GLOBE NEWSWIRE) -- Invivyd, Inc. (Nasdaq: IVVD), a biopharmaceutical company on a mission to protect the vulnerable from serious viral infectious diseases, today announced financial results for the full year ended December 31, 2023 and recent business highlights. “We made remarkable progress throughout 2023 and in recent months. Roughly one year ago we were initiating the Phase 1 clinical trial of VYD222, and today we are incredibly proud to have received emergency use authorization (EUA) of PEMGARDA for PrEP of COVID-19 in certain adults and adolescents (aged 12 or older weighing at least 40kg) in the U.S. with moderate-to-severe immune compromise who are unlikely to mount an adequate response to COVID-19 vaccination,” said Dave Hering, Chief Executive Officer of Invivyd. “PEMGARDA is the first PrEP mAb to receive an EUA using a rapid immunobridging trial design leveraging a biomarker as a surrogate of clinical efficacy and the first authorized mAb from our novel platform approach designed to rapidly and serially engineer durable mAbs targeting conserved viral epitopes. This exciting milestone is a testament to our team’s incredible dedication, skill, and ability to execute to plan.” Mr. Hering continued, “With PEMGARDA now authorized and anticipated to be available for order in the U.S. imminently, we are laser-focused on executing our commercial launch plan and look forward to providing insights on key launch metrics as time progresses. With a relatively compact field sales organization, we believe that we can efficiently reac...