Invivyd (IVVD) Stock News, May-Jul 2025

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 (IVVD) has published results from its CANOPY Phase 3 clinical trial of PEMGARDA® (pemivibart) in Clinical Infectious Diseases. The trial, involving 788 adults across 18 sites, demonstrated 84% relative risk reduction in symptomatic COVID-19 compared to placebo over 6 months. The study included two cohorts: immunocompromised patients and people at risk due to regular indoor interactions. Key findings showed strong protection against modern, immune-evasive SARS-CoV-2 variants. The drug was generally well-tolerated, with mostly mild/moderate adverse events. Notable safety data included infusion-related reactions in 3.6% of Cohort A and 2.2% of Cohort B, and anaphylactic reactions in 0.6% of total participants. This marks the first and only clinical trial of an authorized COVID-19 monoclonal antibody with placebo-controlled data in a contemporary, seropositive U.S. population.

Invivyd (IVVD) announced that its monoclonal antibody PEMGARDA® (pemivibart) has been included in the National Comprehensive Cancer Network® (NCCN®) Clinical Practice Guidelines for B-Cell Lymphomas. This follows the Infectious Disease Society of America (IDSA) update in August 2024 recommending PEMGARDA for pre-exposure prophylaxis in immunocompromised patients. The drug is specifically authorized under FDA Emergency Use Authorization for COVID-19 prevention in moderate-to-severe immunocompromised patients aged 12 or older. PEMGARDA is engineered to maintain effectiveness against circulating SARS-CoV-2 variants, particularly benefiting patients with B-cell malignancies who may have reduced vaccine efficacy. This inclusion in NCCN Guidelines, supported by clinical and real-world evidence, represents a significant advancement in protecting vulnerable cancer patients from COVID-19 complications.

Invivyd (NASDAQ: IVVD) commends the FDA's new approach to evaluating COVID-19 medical interventions, particularly regarding vaccine boosters and monoclonal antibody treatments. The FDA now acknowledges uncertainty in COVID-19 vaccine booster efficacy and encourages manufacturers to conduct randomized, placebo-controlled trials. Invivyd's CANOPY Phase 3 trial of pemivibart demonstrated an 84% reduction in COVID-19 risk compared to placebo over six months, significantly exceeding the FDA's 30% threshold for "meaningful" protection. The company plans to advance improved antibodies for more scalable protection and expects to provide updates on their next-generation monoclonal antibody VYD2311 this quarter. Invivyd aims to engage with the FDA on expedited development pathways for high-risk populations.

Invivyd (NASDAQ: IVVD) reported Q1 2025 financial results, with PEMGARDA™ (pemivibart) generating net product revenue of $11.3 million, down from $13.8 million in Q4 2024. The decrease was attributed to a planned transition from contracted to internalized sales force in early 2025, with revenue re-acceleration observed in Q2. The company reported a net loss of $16.3 million ($0.14 per share), improved from $43.5 million loss in Q1 2024. Cash position stands at $48.1 million, with access to an additional $30 million non-dilutive term loan facility. PEMGARDA shows sustained neutralizing activity against dominant SARS-CoV-2 variants, with no documented anaphylaxis cases since its March 2024 EUA. The company expects VYD2311 Phase 1 trial data later in Q2 2025 and is exploring pipeline expansion beyond SARS-CoV-2 into RSV and measles.

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) has launched a discovery program for a measles monoclonal antibody (mAb) treatment, responding to healthcare providers' requests for treating active measles infections and post-exposure prophylaxis. The company aims to identify a preclinical candidate in 2025, with a progress update expected by year-end. Currently, there are no approved therapies for measles, with existing options limited to Vitamin A and immune globulin (IVIG), both having significant limitations. With over 20 million unvaccinated Americans and declining vaccination rates, the U.S. risks losing its measles elimination status. The proposed mAb treatment could offer advantages including high neutralizing capability, fewer toxicities, and potential use as prophylaxis for at-risk populations, including young children, immunocompromised individuals, and the elderly.