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 ...

Group 1 - Invivyd, Inc. is a biopharmaceutical company focused on providing protection against serious viral infectious diseases, starting with SARS-CoV-2 [2] - The company utilizes its proprietary INVYMAB™ platform, which integrates advanced viral surveillance, predictive modeling, and antibody engineering to rapidly generate new monoclonal antibodies [2] - In March 2024, Invivyd received emergency use authorization (EUA) from the U.S. FDA for its first monoclonal antibody in a series of innovative candidates [2] Group 2 - Invivyd will present at several upcoming investor conferences, including the Morgan Stanley 22nd Annual Global Healthcare Conference on September 6, 2024, and the H.C. Wainwright 26th Annual Global Investment Conference on September 9, 2024 [1] - Live webcasts of the presentations will be available on the company's investor website and archived for approximately 90 days [1]

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, ...

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 ...

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 ...

Company Performance - Invivyd, Inc. reported a quarterly loss of $0.40 per share, which was worse than the Zacks Consensus Estimate of a loss of $0.37, and an improvement from a loss of $0.46 per share a year ago [1] - The company posted revenues of $2.26 million for the quarter ended June 2024, missing the Zacks Consensus Estimate by 53.85%, compared to zero revenues a year ago [2] - The stock has lost approximately 73.1% since the beginning of the year, contrasting with the S&P 500's gain of 13.9% [3] Earnings Outlook - The current consensus EPS estimate for the upcoming quarter is -$0.20 on revenues of $43.01 million, and for the current fiscal year, it is -$0.60 on revenues of $173.95 million [7] - The estimate revisions trend for Invivyd, Inc. is mixed, resulting in a Zacks Rank 3 (Hold), indicating expected performance in line with the market in the near future [6] Industry Context - The Medical - Biomedical and Genetics industry, to which Invivyd belongs, is currently in the top 29% of over 250 Zacks industries, suggesting a favorable outlook compared to lower-ranked industries [8]

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 ...