Invivyd, INC 8-K filings

Invivyd announces that PEMGARDA (pemivibart) continues to demonstrate neutralizing activity against the dominant SARS-CoV-2 variant XEC, according to new in vitro data.

Invivyd, Inc. has been notified by Nasdaq that its stock price has fallen below the minimum required for continued listing, triggering a potential delisting process.

Sara Cotter has resigned from Invivyd Inc.'s Board of Directors and all committees, effective November 27, 2024.

Invivyd announced Q3 2024 financial results, recent business highlights, and the publication of their immunobridging approach for PEMGARDA in the New England Journal of Medicine.

Invivyd announced preliminary Q3 2024 results, including $9.3 million in PEMGARDA net product revenue, withdrew prior financial guidance due to an FDA warning, and released positive long-term clinical efficacy data for PEMGARDA.

Invivyd reports that its antibody treatment, PEMGARDA, maintains consistent neutralization potency against recent SARS-CoV-2 variants, supported by structural analysis showing stability in the antibody's binding site.

Invivyd Inc. released an updated corporate presentation detailing the ongoing launch of their COVID-19 preventative antibody, PEMGARDA, and progress on their next-generation antibody, VYD2311.

Invivyd has begun a Phase 1 clinical trial for VYD2311, a new monoclonal antibody designed to combat evolving COVID-19 variants, building on the success of their previous treatment, PEMGARDA.

Invivyd announced that PEMGARDA (pemivibart) continues to demonstrate neutralizing activity against the dominant SARS-CoV-2 variants KP.3.1.1 and LB.1, as well as other variants of interest.

Invivyd's pemivibart demonstrated an 84% relative risk reduction in symptomatic COVID-19 compared to placebo in an exploratory analysis of its Phase 3 CANOPY trial.

Invivyd launched PEMGARDA commercially in Q2 2024, generating $2.3 million in net product revenue and is preparing for the upcoming respiratory virus season.

Invivyd announced that its monoclonal antibody, VYD222 (pemivibart), demonstrates continued in vitro neutralizing activity against the KP.1.1 FLiRT and KP.3 variants of SARS-CoV-2.

Invivyd appoints a new Chief Commercial Officer and Principal Executive Officer, while also securing FDA alignment on a streamlined pathway for future COVID-19 antibody authorizations.

Invivyd, Inc. announces the election of two new independent directors and provides updates on its commercialization efforts for its first monoclonal antibody.

Invivyd, Inc. announced its first quarter 2024 financial results, the commercial launch of PEMGARDA for COVID-19 pre-exposure prophylaxis, and progress in its pipeline, including plans for a rapid pathway to potential treatment authorization.

Invivyd plans to submit an Emergency Use Authorization (EUA) application for pemivibart as a COVID-19 treatment for immunocompromised individuals, leveraging a rapid immunobridging pathway.

Invivyd has announced a leadership transition, with the CEO stepping down and the Chief Operating Officer appointed as interim CEO, as the company positions itself for its next phase of growth.

Invivyd's PEMGARDA is now commercially available in the U.S., with the company projecting net product revenue between $150 million and $200 million for 2024.

Invivyd, Inc. announced that its monoclonal antibody PEMGARDA has received emergency use authorization from the FDA for the prevention of COVID-19 in certain immunocompromised individuals, marking a significant milestone in the company's efforts to address the evolving virus.

Invivyd's PEMGARDA, a monoclonal antibody, has received FDA emergency use authorization for pre-exposure prophylaxis of COVID-19 in certain immunocompromised individuals, marking a significant milestone for the company.

Invivyd Inc. refiled its 2022 financial statements due to concerns about its ability to continue as a going concern, despite having sufficient funds into the fourth quarter of 2024.