Invivyd (IVVD) Company Overview

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WALTHAM, Mass., Jan. 27, 2025 (GLOBE NEWSWIRE) -- Invivyd, Inc. (Nasdaq: IVVD), a biopharmaceutical company devoted to delivering protection from serious viral infectious diseases, today announced the submission to the U.S. Food and Drug Administration (FDA) of an updated immunobridging analysis of pemivibart as ongoing support of a potential amendment to the Emergency Use Authorization (EUA) for pemivibart, a half-life extended investigational monoclonal antibody (mAb), to include the treatment of mild-to-moderate symptomatic COVID-19 in certain immunocompromised patients for whom alternative COVID-19 treatment options are not accessible or clinically appropriate. PEMGARDA™ (pemivibart) received an EUA from the FDA in March 2024 for pre-exposure prophylaxis (PrEP) of COVID-19 in certain adults and adolescents with moderate-to-severe immune compromise.

WALTHAM, Mass., Jan. 10, 2025 (GLOBE NEWSWIRE) -- Invivyd, Inc. (Nasdaq: IVVD), a biopharmaceutical company devoted to delivering protection from serious viral infectious diseases, today announced that new in vitro neutralization data show continued neutralizing activity of PEMGARDA™ (pemivibart) and pipeline candidate VYD2311 against dominant SARS-CoV-2 variant XEC. As anticipated based on the structural biology of pemivibart and VYD2311, the data are largely consistent with those previously reported for KP.3.1.1. The Centers for Disease Control (CDC) estimates that XEC and KP.3.1.1 accounted for an aggregate 69% of U.S. circulating variants of SARS-CoV-2 for the two weeks ended December 21, 2024. Invivyd generated these new data as part of its ongoing industrial virology effort, which leverages a consistent, high-quality, independent, third-party pseudoviral system that routinely tests authentic Invivyd-produced pemivibart and is supported by extensive structure-based and proprietary analytics.

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Start Time: 08:30 January 1, 0000 9:18 AM ET Invivyd, Inc. (NASDAQ:IVVD ) Q3 2024 Earnings Conference Call November 14, 2024, 08:30 AM ET Company Participants Marc Elia - Chairperson, Board of Directors and Executive Committee Tim Lee - COO Bill Duke - CFO Robert Allen - CSO Mark Wingertzahn - SVP of Clinical Development and Medical Affairs Katie Falzone - VP, Corporate Controller Conference Call Participants Maxwell Skor - Morgan Stanley Michael Yee - Jefferies Jason Kolbert - D. Boral Capital Luis Santos - H.C.

Invivyd, Inc. (IVVD) came out with a quarterly loss of $0.51 per share versus the Zacks Consensus Estimate of a loss of $0.33. This compares to loss of $0.36 per share a year ago.

WALTHAM, Mass., Nov. 14, 2024 (GLOBE NEWSWIRE) -- Invivyd, Inc. (Nasdaq: IVVD), a biopharmaceutical company devoted to delivering protection from serious viral infectious diseases, today announced financial results for the quarter ended September 30, 2024, and recent business highlights.

WALTHAM, Mass., Nov. 14, 2024 (GLOBE NEWSWIRE) -- Invivyd, Inc. (Nasdaq: IVVD), a biopharmaceutical company devoted to delivering protection from serious viral infectious diseases, today announces that The New England Journal of Medicine (NEJM) has published a peer-reviewed Letter to the Editor describing the PEMGARDA™ (pemivibart) immunobridging emergency use authorization (EUA) pathway, as well as an updated correlate of protection (CoP) curve for prevention of symptomatic COVID-19 via recombinant monoclonal antibodies (mAbs) such as pemivibart.

WALTHAM, Mass., Nov. 12, 2024 (GLOBE NEWSWIRE) -- Invivyd, Inc. (Nasdaq: IVVD), a biopharmaceutical company devoted to delivering protection from serious viral infectious diseases, today announced that a manuscript preprint conveying data from the CANOPY Phase 3 clinical trial of pemivibart, a half-life extended investigational monoclonal antibody (mAb) for the pre-exposure prophylaxis (PrEP) of COVID-19, including long-term protection shown versus recent JN.1 sublineages at low residual titers, was uploaded to MedRxiv, and a preprint describing a novel approach for predicting mAb activity was uploaded to BioRxiv.