Welcome to our dedicated page for Invivyd news (Ticker: IVVD), a resource for investors and traders seeking the latest updates and insights on Invivyd stock.
Invivyd, Inc. (Nasdaq: IVVD) is a clinical-stage biopharmaceutical company pioneering monoclonal antibody (mAb) therapies to combat evolving viral threats like COVID-19. This page provides investors and stakeholders with timely updates on Invivyd’s regulatory milestones, clinical trial progress, and strategic initiatives.
Discover the latest developments for PEMGARDA™, Invivyd’s EUA-authorized pre-exposure prophylaxis, and next-generation candidates like VYD2311. Our news collection covers critical updates including FDA communications, partnership announcements, and peer-reviewed data publications. All content is vetted for accuracy and relevance to ensure you stay informed on Invivyd’s progress in protecting immunocompromised populations.
Key focus areas include advancements from the proprietary INVYMAB™ platform, trial results demonstrating variant resistance, and manufacturing scalability updates. Bookmark this page for direct access to press releases, earnings call summaries, and analyses of Invivyd’s role in infectious disease innovation.
Invivyd (NASDAQ:IVVD) has established the SPEAR Study Group, a collaborative research initiative focused on investigating monoclonal antibody therapy for Long COVID and COVID-19 Post-Vaccination Syndrome (PVS). The group was formed following multiple reports of clinical benefits from PEMGARDA® (pemivibart) in Long COVID patients.
The initiative brings together leading researchers including Drs. Michael Peluso, Amy Proal, and David Putrino to conduct rigorous clinical trials evaluating anti-SARS-CoV-2 spike protein monoclonal antibody therapy. The research aims to address conditions believed to be caused by persistent viral reservoirs or circulating spike protein, affecting approximately 5% of Americans.
While PEMGARDA is currently only FDA-authorized for COVID-19 prevention in immunocompromised individuals, the SPEAR Study Group will investigate its potential therapeutic applications for Long COVID, including the use of next-generation candidates like VYD2311.
Invivyd (NASDAQ: IVVD) announced positive Phase 1/2 clinical data for VYD2311, its next-generation COVID-19 monoclonal antibody. The trial demonstrated an excellent safety profile across all dosing methods (IV, SC, and IM), with only mild to moderate adverse events reported.
Key highlights include extended serum concentration duration, with the IM dose showing the longest half-life of 76.0 days. The antibody showed potential for long-term COVID-19 protection lasting multiple quarters, potentially exceeding vaccine durability. VYD2311 builds upon Invivyd's first-generation mAb, pemivibart, with 99%+ structural similarity but improved potency and resistance profile.
The company has scheduled a Type C meeting with FDA in early Q3 2025 to discuss registration-directed next steps and approval pathways for both prevention and treatment applications.
Invivyd (NASDAQ: IVVD) has submitted a Citizen Petition to the FDA advocating for a shift in how COVID-19 preventative treatments are evaluated. The company argues that current vaccine efficacy data needs reassessment due to three key factors: the widespread immunity in the population, the emergence of immune-evasive Omicron variants, and better understanding of vaccine efficacy waning.
The petition urges the FDA to require new clinical trials for COVID-19 vaccines that include: 1) seropositive patients in randomized controlled trials, 2) testing against contemporary Omicron variants, and 3) efficacy measurements over 6+ months. Additionally, Invivyd recommends using serum virus neutralizing antibody (sVNA) titers as a basis for Biologics License Application approval for monoclonal antibodies.
[ "Company is taking proactive steps to influence regulatory framework for COVID-19 treatments", "Petition could potentially streamline approval process for Invivyd's monoclonal antibody treatments", "Company demonstrates scientific leadership in addressing evolving COVID-19 challenges" ]Invivyd (NASDAQ: IVVD) has announced its participation in the H.C. Wainwright 3rd Annual BioConnect Investor Conference. The company's management will engage in a fireside chat on Tuesday, May 20, 2025, at 11:00 a.m. ET in New York. Management will also be available for investor meetings during the conference.
Interested investors attending the conference can arrange meetings through their H.C. Wainwright representative. The fireside chat will be accessible via live webcast on the company's investor relations website at investors.invivyd.com and will remain available for approximately 30 days after the presentation.
Invivyd (NASDAQ: IVVD), a biopharmaceutical company focused on protection against serious viral infectious diseases, has scheduled a conference call for Thursday, May 15, 2025, at 8:30 a.m. ET. The call will cover the company's first quarter 2025 financial results for the period ending March 31, 2025, along with recent business updates.
Analysts interested in participating in the Q&A session should join 15 minutes before the start time. The webcast will be available for replay on Invivyd's investor relations website approximately two hours after the call concludes.