Invivyd’s VYD2311 Meets LIBERTY Phase 3 Safety Endpoints Against an mRNA COVID-19 Vaccine

Invivyd, Inc. (NASDAQ: IVVD), the New Haven, Connecticut developer of antibodies against viral infectious diseases, announced on September 29, 2026 topline results from LIBERTY, a Phase 3 study comparing the safety and tolerability of its investigational COVID-19 monoclonal antibody VYD2311 with an mRNA-based COVID-19 vaccine. The company reports that VYD2311 met all primary and secondary endpoints in that comparison. It now plans to pursue a Biologics License Application under the FDA’s Accelerated Approval Program, pending results from its larger DECLARATION study.

What LIBERTY Measured

LIBERTY enrolled 210 healthy adults aged 18 to 49 and randomized them equally to a single 250mg intramuscular dose of VYD2311, the mRNA vaccine COMIRNATY, or both together. Every participant received two injections, with placebo used to keep the study blinded. The 250mg dose is the same one under evaluation in DECLARATION.

On the first co-primary endpoint, 56.5% of participants in the VYD2311 arm experienced a treatment-emergent adverse event, injection site reaction or hypersensitivity reaction within six days, compared with 91.4% in the vaccine arm (P<0.0001). On the second, systemic adverse events over six days occurred in 44.1% of the VYD2311 arm versus 68.1% of the vaccine arm (P=0.008). Over the full 56 days, the key secondary endpoint was 60.9% versus 91.4% (P<0.0001). According to the company, no adverse events related to VYD2311 were higher than Grade 2, and no hypersensitivity or anaphylaxis was observed in any arm.

The combination arm produced mixed statistical results against the vaccine alone: 78.9% on the first co-primary endpoint (P=0.057), 50.0% on systemic events (P=0.023), and 83.1% over 56 days (P=0.21). In addition, Invivyd reports that adding VYD2311 raised neutralizing titers by approximately 2.5 times over the vaccine alone, with no sign of interference with the vaccine’s own response. LIBERTY was designed to evaluate safety, tolerability and antibody levels; protection against symptomatic COVID-19 is the subject of DECLARATION.

The Regulatory Plan

Following a Type C meeting with the FDA in September, Invivyd intends to submit a BLA under the Accelerated Approval Program if DECLARATION’s data are supportive. DECLARATION is a placebo-controlled Phase 3 trial of approximately 2,400 adults and adolescents testing single and monthly doses of VYD2311. The company plans to unblind and report placebo-controlled safety and neutralizing titer data in October, while keeping clinical event data blinded.

Under this plan, efficacy data would be unblinded after accelerated approval, if granted, and subject to event accrual. Invivyd intends to keep accumulating symptomatic COVID-19 cases in a post-approval confirmatory cohort, targeting a 70% to 90% relative risk reduction versus placebo. The release does not give a date for the BLA submission.

“The LIBERTY data provide us with high confidence in the profile of VYD2311,” said Michael Mina, M.D., Ph.D., Chief Medical Officer and Chief Epidemiologist. Chairman and Chief Executive Officer Marc Elia said the company wants “to move as quickly as possible to the regulatory filings required.”

Commercial Revenue and Financial Position

Invivyd already sells PEMGARDA (pemivibart), which received emergency use authorization in March 2024 for pre-exposure prophylaxis of COVID-19 in certain immunocompromised patients. In the second quarter of 2026, PEMGARDA net product revenue was $14.3 million, up 21% from $11.8 million a year earlier. Research and development expenses rose to $29.4 million from $9.6 million, and selling, general and administrative expenses rose to $29.5 million from $16.6 million. The quarterly net loss was $44.4 million, compared with $14.7 million.

Cash and cash equivalents were $160.1 million at June 30, 2026, which the company anticipated would provide runway through the DECLARATION readout and support potential launch readiness for VYD2311.

Separately, Invivyd received a NASDAQ deficiency letter on July 23, 2026 after its stock closed below the $1.00 minimum bid price for 30 consecutive business days, and it has until January 19, 2027 to regain compliance. On September 1, the board appointed Chairman Marc Elia as Chief Executive Officer.

Strategic Investment Summary

• Topline Results: Invivyd, Inc. (NASDAQ: IVVD) reported that VYD2311 met all primary and secondary endpoints in the LIBERTY Phase 3 study comparing it with an mRNA-based COVID-19 vaccine in 210 healthy adults.
• Safety Figures: Six-day adverse events occurred in 56.5% of VYD2311 recipients versus 91.4% for the vaccine (P<0.0001), with no VYD2311-related events above Grade 2 and no hypersensitivity or anaphylaxis in any arm.
• Study Scope: LIBERTY measured safety, tolerability and antibody levels in healthy adults aged 18 to 49; clinical efficacy is being evaluated in the placebo-controlled DECLARATION trial of approximately 2,400 participants.
• Regulatory Path: Following a September Type C meeting, Invivyd plans a BLA under Accelerated Approval if DECLARATION safety and titer data, expected in October, are supportive; no submission date has been given.
• Current Business: PEMGARDA net product revenue was $14.3 million in the second quarter of 2026, up 21%, against a net loss of $44.4 million.
• Balance Sheet and Listing: Cash and cash equivalents were $160.1 million at June 30, and the company has until January 19, 2027 to regain compliance with the NASDAQ $1.00 minimum bid price requirement.

Find out more about the latest corporate developments and financial reports at the Invivyd investor portal.