Business
Invivyd Reports Third Quarter 2023 Financial Results and Recent Business Highlights
Enrollment completed in CANOPY Phase 3 pivotal clinical trial investigating VYD222 for the prevention of symptomatic COVID-19Company expects to have initial
About this update from Invivyd, Inc.
[{"type":"text","content":"Enrollment completed in CANOPY Phase 3 pivotal clinical trial investigating VYD222 for the prevention of symptomatic COVID-19Company expects to have initial CANOPY primary endpoint data by late 2023 or early Q1 2024Company aims to submit an application for Emergency Use Authorization (EUA) in the U.S. as soon as practicableCompany continues to advance INVYMABTM, its proprietary platform approach designed for rapid, serial generation of new antibodies to address viral threatsCash, cash equivalents and marketable securities of $264.9 million expected to support operating runway remains into the fourth quarter of 2024, excluding potential contribution of commercial product revenue Conference call scheduled for Thursday, November 9th at 4:30 p.m. ET WALTHAM, Mass., Nov. 09, 2023 (GLOBE NEWSWIRE) -- Invivyd, Inc. (Nasdaq: IVVD), a clinical-stage biopharmaceutical company on a mission to protect the vulnerable from serious viral infectious diseases, today announced financial results for the quarter ended September 30, 2023, and recent business highlights. “I am immensely proud of our team and their remarkable performance throughout the third quarter. In September, less than six months after initiating a Phase 1 clinical trial, we announced we had dosed the first participant in CANOPY, our Phase 3 pivotal clinical trial investigating VYD222 for the prevention of symptomatic COVID-19. Today we are pleased to announce that we have completed enrollment in the CANOPY trial and continue to expect to have initial primary endpoint data in late 2023 or early Q1 2024,” said Dave Hering, Chief Executive Officer of Invivyd. “Given the urgent unmet medical need, we continue to aim to submit an application for EUA to the U.S. Food and Drug Administration (FDA) as soon as practicable.” Mr. Hering added, “In preparation for a potential EUA, we have been engaged in commercial planning for an anticipated market entry of VYD222 in 2024. With an estimated total addressable market of more than 9 million immunocompromised individuals in the U.S., our teams have been developing and refining our strategy, which will initially focus on serving the highest risk immunocompromised people. Furthermore, we continue to have constructive dialogue with the FDA regarding potential pathways that would enable us to fully leverage our INVYMAB platform approach to rapidly...