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 ...

KP.3.1.1 and LB.1 in vitro neutralization potency values now reflected in the PEMGARDA Fact Sheet for Healthcare Providers are in-line with prior variants, including variants represented in the CANOPY Phase 3 clinical trial Invivyd continues active variant monitoring using validated, robust methods and is not aware of any circulating variants not susceptible to PEMGARDA at this time WALTHAM, Mass., Oct. 01, 2024 (GLOBE NEWSWIRE) -- Invivyd, Inc. (Nasdaq: IVVD), a biopharmaceutical company devoted to deliver ...

Independent evaluation of KP.3.1.1 and LB.1 variants shows in vitro pseudovirus neutralization potency of PEMGARDA in-line with prior variants tested Proprietary, ongoing SARS-CoV-2 spike analyses demonstrate consistent structural stability of the pemivibart binding site to date, which has routinely predicted sustained pemivibart in vitro neutralization activity Potential emerging variants, such as XEC and LP.1, encode mutations that are distal from the pemivibart binding site, and, therefore, are also not ...

Centers for Disease Control and Prevention (CDC) reports death rate due to COVID-19 has continued to increase throughout 2024 Immunocompromised patients at greatest risk for serious infections or even death due to COVID-19 PEMGARDA™ available under Emergency Use Authorization (EUA) for certain immunocompromised adults and adolescents; recommended by Infectious Disease Society of Americas (IDSA) guidelines Covered by Medicare and Medicaid and has achieved rapid growth in commercial coverage across national a ...