Treatment immunobridging analysis, routinely updated for contemporary SARS-CoV-2 variants, compares pemivibart antiviral titers to adintrevimab antiviral titers from the company’s previous Phase 2/3 clinical trial of adintrevimab for the treatment of COVID-19 (STAMP), in which adintrevimab conferred a 66% to 74% reduction in risk of hospitalization or death from COVID-19 compared to placebo depending on time of therapy startMost recent updated analysis provided to FDA, incorporating current dominant SARS-Co ...

Core Findings - New in vitro neutralization data show continued neutralizing activity of PEMGARDA™ (pemivibart) and pipeline candidate VYD2311 against dominant SARS-CoV-2 variant XEC, consistent with previous data for KP 3 1 1 [1][2] - XEC and KP 3 1 1 accounted for 69% of U S circulating SARS-CoV-2 variants for the two weeks ended December 21, 2024 [1] - PEMGARDA has demonstrated neutralizing activity against over 75% of currently circulating U S variants and all prior variants tested to date [6] - Data submitted to FDA, with timely update to PEMGARDA™ Fact Sheet for Healthcare Providers anticipated [2][7] Product Details - PEMGARDA (pemivibart) is an investigational monoclonal antibody (mAb) authorized for emergency use by the U S FDA for pre-exposure prophylaxis of COVID-19 in certain adults and adolescents with moderate-to-severe immune compromise [3][11] - PEMGARDA targets the SARS-CoV-2 spike protein receptor binding domain (RBD), inhibiting virus attachment to the human ACE2 receptor on host cells [11] - VYD2311, a novel mAb candidate, is being developed for COVID-19 to address the urgent need for new therapeutic options for vulnerable populations, including immunocompromised individuals [15][16] Research and Development - Invivyd leverages a consistent, high-quality, independent, third-party pseudoviral system for testing pemivibart, supported by extensive structure-based and proprietary analytics [1][9] - The company's INVYMAB™ platform combines viral surveillance, predictive modeling, and advanced antibody engineering to facilitate the rapid, serial generation of new mAbs to address evolving viral threats [17] - Pemivibart has demonstrated antiviral activity in neutralization assays representing 39 distinct SARS-CoV-2 variants across almost three years of rapid virus evolution [10] Market and Industry Context - The emergency use of PEMGARDA is authorized only when the combined national frequency of variants with substantially reduced susceptibility to PEMGARDA is ≤90% [14] - Invivyd received emergency use authorization (EUA) from the U S FDA for PEMGARDA in March 2024, marking its first mAb in a planned series of innovative antibody candidates [17]

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. These figures are adjusted for non-recurring items.This quarterly report represents an earnings surprise of -54.55%. A quarter ago, it was expected that this company would post a loss of $0.37 per share when it actually produced a loss of $0.40, delivering a surprise of -8.11%.Over the last four quarters, the company has surpassed ...

Q3 2024 PEMGARDA™ (pemivibart) net product revenue of $9.3 million; Invivyd ended Q3 2024 with $106.9 million in cash and cash equivalentsTargets near-term (1H 2025) profitability with existing cash and cash equivalents, anticipated growth of net product revenue, and various operational efficiency improvementsPEMGARDA Fact Sheet updated to properly reflect neutralization activity of PEMGARDA against current circulating variants tested; on track for continued growth now reflective of ongoing commercial optim ...

The New England Journal of Medicine (NEJM) Letter to the Editor outlines the novel, rapid immunobridging authorization pathway for PEMGARDA and provides an updated correlate of protection curve for monoclonal antibody protection from symptomatic COVID-19The updated correlate of protection analysis published in the Letter to the Editor indicates the potential for strong protection from symptomatic COVID-19 at titer levels well below doses explored clinically with pemivibart, consistent with recently disclose ...

WALTHAM, Mass., Nov. 06, 2024 (GLOBE NEWSWIRE) -- Invivyd, Inc. (Nasdaq: IVVD), a biopharmaceutical company devoted to delivering protection from serious viral infectious diseases, today announced that management will participate in a fireside chat and 1x1 investor meetings at the Guggenheim Securities Healthcare Innovation Conference taking place November 11-13, 2024. Fireside Chat: Wednesday, November 13, 2024 at 2:30 PM ET Location: Boston, MA The live webcast link will be available in the investor secti ...

WALTHAM, Mass., Nov. 06, 2024 (GLOBE NEWSWIRE) -- Invivyd, Inc. (Nasdaq: IVVD), a biopharmaceutical company devoted to delivering protection from serious viral infectious diseases, today announced that it will host a conference call on Thursday, November 14, 2024, at 8:30 a.m. ET to discuss its financial results for the third quarter ended September 30, 2024, and provide recent business highlights. Invivyd reported preliminary third quarter 2024 results via press release on October 29, 2024. Listeners can r ...

Preliminary Q3 2024 PEMGARDA™ (pemivibart) net product revenue of $9.3 million; Invivyd ended Q3 2024 with approximately $107 million in cash and cash equivalents Expects to finish 2024 with $65 million or more in cash and cash equivalents Withdraws formal revenue guidance due to recent growth headwind from U.S. FDA's late-Q3 2024 warning on potential for substantially reduced activity of pemivibart through the PEMGARDA Fact Sheet and other media based on contested, third-party, non-peer-reviewed, non-repro ...

Following strong protection (84% relative risk reduction versus placebo) demonstrated through month 6 with pemivibart, CANOPY clinical trial participants were followed for an additional six-month period (months 7-12), with no additional doses, to assess safety and efficacy as drug concentrations declined over time In the six-month off-drug follow-up period (months 7-12), substantially reduced concentrations of PEMGARDA reduced the risk of symptomatic COVID-19 by 64% compared to placebo in an immunocompetent ...

WALTHAM, Mass., Oct. 16, 2024 (GLOBE NEWSWIRE) -- Invivyd, Inc. (Nasdaq: IVVD), a biopharmaceutical company devoted to delivering protection from serious viral infectious diseases, today announced the upcoming presentations of pemivibart data from its Phase 1 and Phase 3 clinical trials at IDWeek 2024. The conference is being held in Los Angeles, October 16-19, 2024. Poster: Pharmacokinetics (PK) and Serum Virus Neutralizing Antibody (sVNA) Titers Following the 2nd dose of Pemivibart in the Phase 3 CANOPY T ...