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Invivyd Announces U.S. FDA Has Updated the PEMGARDA™ EUA Fact Sheet with Accurate SARS-CoV-2 Variant Susceptibility and PEMGARDA Activity Data
GlobeNewswire News Room· 2024-10-01 11:01
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 ...
Invivyd Provides Detailed Virology Data and Analysis of SARS-CoV-2 Structural Biology Predicting Anticipated Neutralization Activity for PEMGARDA™ (pemivibart)
GlobeNewswire News Room· 2024-09-23 11:01
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 ...
Invivyd at the Ready for Upcoming Respiratory Virus Season with PEMGARDA™ (pemivibart) to Help Protect Vulnerable Immunocompromised Persons from COVID-19
GlobeNewswire News Room· 2024-09-12 11:01
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 ...
Invivyd to Participate in Upcoming Investor Conferences
GlobeNewswire News Room· 2024-09-05 11:01
WALTHAM, Mass., Sept. 05, 2024 (GLOBE NEWSWIRE) -- Invivyd, Inc. (Nasdaq: IVVD), a biopharmaceutical company devoted to delivering protection from serious viral infectious diseases, today announced that it will present at the following investor conferences: Morgan Stanley 22nd Annual Global Healthcare Conference Fireside Chat Date: Friday, September 6, 2024 Fireside Chat Time: 10:00 AM ET Location: New York, NY H.C. Wainwright 26th Annual Global Investment Conference Fireside Chat Date: Monday, September 9, ...
Invivyd Doses First Participants in Phase 1 Clinical Trial of VYD2311, a Next Generation Monoclonal Antibody Candidate for COVID-19, Building on the Success of PEMGARDA™
GlobeNewswire News Room· 2024-09-04 11:01
WALTHAM, Mass., Sept. 04, 2024 (GLOBE NEWSWIRE) -- Invivyd, Inc. (Nasdaq: IVVD), a biopharmaceutical company devoted to delivering protection from serious viral infectious diseases, today announced dosing of the first participants in the Phase 1 healthy volunteer clinical trial of VYD2311, a next generation monoclonal antibody (mAb) candidate for COVID-19. VYD2311 is a mAb with high in vitro neutralization potency shown against post-Omicron COVID-19 variants tested to date. The Phase 1 randomized, blinded, ...
Invivyd Announces Continued Neutralizing Activity of PEMGARDA™ (pemivibart) Against Dominant SARS-CoV-2 Variants KP.3.1.1 and LB.1, and Other Variants of Interest
GlobeNewswire News Room· 2024-09-03 11:01
New pseudovirus in vitro neutralization data show continued neutralizing activity of PEMGARDA™ (pemivibart) against KP.3.1.1, LB.1, and other SARS-CoV-2 variants tested Center for Disease Control reports KP.3.1.1 is the only major variant increasing in proportionality nationally Variants confirmed as susceptible to pemivibart in independent analyses contain key Q493E, s31del, and other mutations that are prominent in circulating SARS-CoV-2 variants Data submitted to FDA for anticipated timely updates to PEM ...
Invivyd Announces PEMGARDA™ (pemivibart) Demonstrated 84% Relative Risk Reduction in Symptomatic COVID-19 Compared to Placebo in an Exploratory Analysis from Ongoing CANOPY Phase 3 Clinical Trial
GlobeNewswire News Room· 2024-08-27 11:01
In all-comer cohort of immunocompetent individuals at risk of contracting symptomatic COVID-19 in their everyday social interactions, participants receiving pemivibart experienced a 1.9% rate of confirmed symptomatic COVID-19 compared to an 11.9% rate for participants receiving placebo, an 84% relative risk reduction (nominal p= 0.000061) In immunocompromised participants, pemivibart demonstrated a rate of 3% of confirmed symptomatic COVID-19, an encouraging potential signal of protection during the assesse ...
Invivyd, Inc. (IVVD) Reports Q2 Loss, Lags Revenue Estimates
ZACKS· 2024-08-14 14:11
Invivyd, Inc. (IVVD) came out with a quarterly loss of $0.40 per share versus the Zacks Consensus Estimate of a loss of $0.37. This compares to loss of $0.46 per share a year ago. These figures are adjusted for non-recurring items. This quarterly report represents an earnings surprise of -8.11%. A quarter ago, it was expected that this company would post a loss of $0.51 per share when it actually produced a loss of $0.38, delivering a surprise of 25.49%. Over the last four quarters, the company has surpasse ...
Invivyd Reports Second Quarter 2024 Financial Results and Recent Business Highlights
GlobeNewswire News Room· 2024-08-14 12:01
PEMGARDA™ launched commercially in Q2 2024 with $2.3 million of net product revenue Notable acceleration of commercial results in early Q3 2024, with the anticipated peak fall/winter respiratory virus season approaching New commercial leadership with Chief Commercial Officer, Tim Lee, an experienced biopharmaceutical leader with demonstrated commercial success Achieved Medicare and Medicaid coverage, rapid growth in commercial coverage across national and regional plans, and strong growth in infusion center ...
Invivyd to Host Conference Call Discussing Second Quarter 2024 Financial Results and Business Highlights
GlobeNewswire News Room· 2024-08-12 20:01
WALTHAM, Mass., Aug. 12, 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 Wednesday, August 14, 2024, at 8:30 a.m. ET to discuss its financial results for the second quarter ended June 30, 2024, and recent business highlights. Listeners can register for the webcast via this link. Analysts wishing to participate in the question and answer session sh ...