Invivyd, Inc.

Invivyd Presents VMS063, a Potential Best-in-Class Monoclonal Antibody Candidate for the Treatment and Prevention of Measles, at IDWeek 2026

Invivyd presented preclinical data on VMS063, its investigational monoclonal antibody for treatment and prevention of measles, at IDWeek 2026. VMS063 showed potent in vitro neutralization against contemporary measles genotypes B3 and D8, with a half-life-extended profile and intramuscular or subcutaneous delivery planned. The company has begun manufacturing scale-up toward clinical development in 2027, targeting an area with no FDA-approved treatments amid record U.S. measles incidence.

•11d ago

Invivyd and the SPEAR Study Group Announce Initiation of “FLINTLOCK” Phase 2 Study of VYD2311, a Monoclonal Antibody for the Potential Treatment of Long COVID or Post-Vaccination Syndrome

Invivyd and the SPEAR Study Group initiated FLINTLOCK, a Phase 2 randomized, placebo-controlled trial of high-dose monoclonal antibody VYD2311 in adults with Long COVID or Post-Vaccination Syndrome. The trial enrolls approximately 130 participants, testing an IV loading dose followed by intramuscular injections at days 30 and 60 at a total dose targeted at 10x the prophylactic dose, with initial data expected in mid-2027. FLINTLOCK is part of the broader REVOLUTION program for VYD2311, which also includes the Phase 3 DECLARATION (~2,400 participants) and LIBERTY (~210 participants) trials; it represents a new therapeutic indication beyond PEMGARDA's EUA-limited prophylaxis franchise.

•18d ago

Invivyd Announces Positive Topline Results from LIBERTY Phase 3 Study Demonstrating VYD2311 Safety and Tolerability Superior to mRNA-based COVID-19 Vaccine; Announces Regulatory Submission Plans for VYD2311

Invivyd announced positive topline results from the LIBERTY Phase 3 study, with VYD2311 meeting all primary and secondary endpoints and demonstrating safety and tolerability statistically superior to COMIRNATY mRNA COVID-19 vaccine (56.5% vs 91.4% experiencing TEAEs at 6 days, P <0.0001). The VYD2311-plus-vaccine combination added approximately 2.5x to vaccine-induced neutralizing titers with no immunologic interference, and no Grade 3+ adverse events, hypersensitivity, or anaphylaxis were observed with VYD2311. Following a recent FDA Type C meeting, Invivyd plans to submit a BLA for VYD2311 via the Accelerated Approval Program based on LIBERTY and the ongoing DECLARATION pivotal study, with DECLARATION safety and immunogenicity topline data expected in October 2026.

•1mo ago

Invivyd Appoints Chairman Marc W. Elia as Chief Executive Officer; Approaches Results of VYD2311 studies DECLARATION and LIBERTY

Invivyd appointed Chairman Marc Elia as Chief Executive Officer, adding the top executive role to his existing responsibilities while Ajay Royan was named Lead Independent Director. Ian Sheffield also joined the board as an independent director, bringing two decades of healthcare investment experience. The company provided a regulatory update for its VYD2311 program, anticipating top-line data from the Phase 3 DECLARATION and LIBERTY studies by the end of Q3 2026. Management plans to unblind the DECLARATION study and submit a Biologics License Application, pursuing either traditional or accelerated approval paths. The DECLARATION trial has enrolled approximately 2,400 participants to evaluate the efficacy of VYD2311 in preventing symptomatic COVID-19 across a broad population.

•2mo ago

Invivyd Reports Second Quarter 2026 Financial Results and Recent Business Highlights

Invivyd reported Q2 2026 net product revenue of $14.3 million, up 21% from the prior year, while narrowing its net loss to $44.4 million despite increased clinical trial investments. The company achieved key clinical milestones, completing enrollment in the pivotal DECLARATION Phase 3 trial and fully dosing the LIBERTY Phase 3 trial for VYD2311, with top-line data from both studies anticipated in late Q3 2026. Invivyd ended the quarter with $160.1 million in cash, expected to fund operations through the VYD2311 data readout and potential launch, though it acknowledged receipt of a notice of EUA termination for PEMGARDA effective June 2027.

•2mo ago

Invivyd Announces First Participants Dosed in LIBERTY, a Phase 3 Clinical Trial to Evaluate the Safety and Tolerability of VYD2311 Antibody Versus mRNA COVID Vaccine and to Characterize the Safety and Immunology of Antibody and mRNA Vaccine Co-Administration

Invivyd has dosed the first participants in LIBERTY, a Phase 3 clinical trial evaluating the safety and tolerability of its monoclonal antibody candidate VYD2311 versus mRNA COVID-19 vaccines. The trial will enroll approximately 210 healthy adults across three arms: VYD2311 alone, mRNA vaccine alone, and co-administration of both. This head-to-head design aims to characterize VYD2311 as a more tolerable alternative to traditional vaccination. Invivyd expects to report topline data from LIBERTY in Q3 2026, coinciding with anticipated data from its pivotal DECLARATION efficacy trial. The company positions VYD2311 as a potential new standard of care for COVID-19 prevention, particularly for those hesitant about vaccine side effects.

•4mo ago

Invivyd Announces Completion of Enrollment in Upsized DECLARATION Clinical Trial, a Phase 3 Pivotal Study of VYD2311, an Investigational Antibody to Prevent COVID

Invivyd announced the completion of enrollment in its DECLARATION Phase 3 pivotal trial for VYD2311, a monoclonal antibody candidate for COVID-19 prevention. The trial was upsized by approximately 500 subjects following a pre-specified sample size re-estimation analysis to ensure statistical robustness against variable COVID event rates. Top-line results are expected in late Q3 2026, with the company anticipating additional event accumulation during the summer COVID wave in the U.S.

•5mo ago

Invivyd Reports First Quarter 2026 Financial Results and Recent Business Highlights

Invivyd reported Q1 2026 net product revenue of $13.7 million for PEMGARDA, a 22% increase from $11.3 million in Q1 2025. The company's cash and cash equivalents stood at $184.2 million as of March 31, 2026, with an additional $20 million raised in April 2026 through an ATM offering facility. R&D expenses increased to $30.7 million in Q1 2026 from $10.6 million in Q1 2025, primarily due to the DECLARATION clinical trial for VYD2311. Invivyd announced positive in vitro neutralization data for VYD2311 and PEMGARDA against the SARS-CoV-2 variant BA.3.2.2, and the IDMC recommended reducing post-dose monitoring time from two hours to 30 minutes in the DECLARATION trial.

•5mo ago