WALTHAM, Mass., March 05, 2025 (GLOBE NEWSWIRE) -- Invivyd, Inc. (Nasdaq: IVVD) today announced positive, continued, clinically meaningful in vitro neutralization data for PEMGARDA™ (pemivibart) against the currently dominant LP.8.1 variant of SARS-CoV-2. Notably, and consistent with all dominant variants for the past three years, LP.8.1 did not generate any meaningful change to the neutralization activity of pemivibart or VYD2311, the company's next generation COVID-19 monoclonal antibody (mAb) candidate, as the epitope these mAbs target remains structurally intact. PEMGARDA (pemivibart) is authorized in the U.S. for pre-exposure prophylaxis of COVID-19 in certain immunocompromised patients.
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On Monday, the FDA declined Invivyd, Inc.'s IVVD request to expand the existing emergency use authorization (EUA) for pre-exposure prophylaxis of COVID-19 EUA for Pemgarda (pemivibart) for mild-to-moderate COVID-19 in adults and adolescents who have moderate-to-severe immune compromise.
WALTHAM, Mass., Feb. 24, 2025 (GLOBE NEWSWIRE) -- Invivyd, Inc. (Nasdaq: IVVD) today announced that Invivyd's request to expand the existing emergency use authorization (EUA) for pre-exposure prophylaxis of COVID-19 EUA for PEMGARDA™ (pemivibart) to provide a treatment option for mild-to-moderate COVID-19 in adults and adolescents who have moderate-to-severe immune compromise due to certain medical conditions such as cancer and organ transplant, and for whom alternative COVID-19 treatment options are not accessible or clinically appropriate, was declined by the U.S. Food and Drug Administration (FDA). Existing PEMGARDA™ (pemivibart) EUA for pre-exposure prophylaxis of COVID-19 in certain immunocompromised patients remains in effect.
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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.