NEW HAVEN, Conn. — March 5, 2026 — Leads & Copy — Invivyd, Inc. (Nasdaq: IVVD) has released its financial results for the fourth quarter and full year ending December 31, 2025, along with recent business highlights.
The company achieved Q4 2025 PEMGARDA® (pemivibart) net product revenue of $17.2 million, a 25% increase year-over-year and a 31% increase quarter-over-quarter. Year-end cash and cash equivalents for 2025 totaled $226.7 million after raising over $200 million from financing transactions in the second half of 2025.
Invivyd announced the initiation of the DECLARATION Phase 3 pivotal clinical trial for VYD2311, a vaccine-alternative antibody to prevent COVID, with top-line data expected by mid-2026. The FDA granted Fast Track designation for VYD2311 in December 2025.
The DECLARATION trial has achieved full enrollment. An Independent Data Monitoring Committee (IDMC) review of unblinded VYD2311 safety data resulted in a recommendation to allow enrollment of pregnant and breastfeeding women in the trial.
Blinded, pooled early COVID event accumulation in the DECLARATION trial appears on track. A potential re-sizing decision could occur in approximately April, depending on trial progress.
Michael Mina, M.D., Ph.D., has been appointed Chief Medical Officer.
According to Bill Duke, Chief Financial Officer of Invivyd, the company is encouraged by the commercial execution and appeal for monoclonal antibody prophylaxis, demonstrated by PEMGARDA® revenue more than doubling year-over-year, while operating expenses decreased by nearly half. Duke added that Invivyd’s recent capital raises enable investment in the ongoing DECLARATION pivotal clinical trial and potential commercialization of VYD2311, if approved, along with other pipeline programs.
Marc Elia, Chairman of the Invivyd Board of Directors, said that 2026 is off to a busy start as the company executes its pivotal VYD2311 program, expands its pipeline of monoclonal antibodies, and educates stakeholders about the role of monoclonal antibodies in preventing critical infectious diseases, starting with COVID. He added that the company remains focused on creating medical value for patients and shareholders with molecules that can complement, provide an alternative to, or synergize with vaccination across multiple pathogens.
The DECLARATION trial recruitment has progressed rapidly with full enrollment achieved, following trial initiation in late 2025.
The IDMC, responsible for monitoring safety in the DECLARATION trial, recently completed its review of unblinded safety data and made the following recommendations:
- Pregnant and breastfeeding women are now eligible to participate in the study and may enroll.
- Women of childbearing age are no longer required to use contraception.
- Pre-existing protocol-specified safety visits and evaluations at Day 8, Day 38, and Day 68 are no longer required.
Early blinded, pooled COVID events in the DECLARATION trial are beginning to accumulate and suggest overall trial progress is on track.
In February 2026, Invivyd announced it received and was aligned with advice from the FDA on the LIBERTY Phase 3 clinical trial, which will assess the safety and immunologic profile of VYD2311 versus commercially available mRNA COVID vaccines.
LIBERTY is part of the company’s broader REVOLUTION clinical program and will evaluate comparative safety and immunology of VYD2311 versus mRNA COVID vaccine, as well as explore the safety and immunology of co-administered VYD2311 and mRNA COVID vaccine.
In January 2026, Invivyd and the SPEAR Study Group announced the plan to initiate a Phase 2 clinical trial evaluating VYD2311 in individuals with Long COVID or COVID vaccine injury. The Phase 2 clinical trial is expected to be initiated by mid-2026.
The primary endpoint of DECLARATION is the reduction of PCR-confirmed symptomatic COVID incidence versus placebo, with total expected enrollment of 1770 people across all three arms.
In the Phase 1/2 clinical trial, IM administered VYD2311 was well tolerated, with all adverse events (AEs) considered mild to moderate in severity with no serious or severe AEs reported.
In November 2025, Invivyd announced selection of a potential best-in-class Respiratory Syncytial Virus (RSV) antibody candidate VBY329, designed for the prevention of RSV infections in newborns, infants, and children.
Invivyd expects to advance VBY329 toward IND readiness in 2H 2026 for development in pediatric RSV prophylaxis.
Invivyd has initiated discovery efforts to assess pipeline expansion beyond SARS-CoV-2 and RSV, and anticipates providing an update on selection of a preclinical measles monoclonal antibody candidate in the first half of 2026.
In January 2026, Invivyd announced its partnership with ski champion Lindsey Vonn to elevate public understanding of antibodies and their role in preventing disease. A national multimedia educational campaign is planned to launch in early Spring 2026.
Financial results show full-year 2025 net product revenue of PEMGARDA of $53.4 million, compared to $25.4 million in 2024. Research & Development (R&D) expenses were $38.3 million for the year ended December 31, 2025, compared to $137.3 million for the comparable period in 2024. Net loss was $52.5 million for the year ended December 31, 2025, compared to $169.9 million for the comparable period in 2024.
Listeners can register for the webcast via this link. Analysts wishing to participate in the question-and-answer session should use this link. A replay of the webcast will be available via the company’s investor website approximately two hours after the call’s conclusion. Those who plan on participating are advised to join 15 minutes prior to the start time.
PEMGARDA is a half-life extended investigational monoclonal antibody (mAb) engineered from adintrevimab. It has demonstrated in vitro neutralizing activity against major SARS-CoV-2 variants.
VYD2311 is a novel monoclonal antibody (mAb) candidate being developed for COVID-19, engineered using Invivyd’s proprietary integrated technology platform.
DECLARATION (NCT07298434) is a Phase 3 trial to evaluate VYD2311 efficacy and safety in prevention of symptomatic COVID.
LIBERTY is a Phase 3 clinical trial to evaluate the safety, serum virus neutralizing antibody responses, and pharmacokinetics of VYD2311.
VBY329 is a novel monoclonal antibody (mAb) candidate being developed to prevent Respiratory Syncytial Virus (RSV) among neonates, infants, and children.
Invivyd and leading researchers formed the SPEAR Study Group to assess the effects of monoclonal antibody (mAb) therapy for Long COVID and COVID-19 Post-Vaccination Syndrome.
Invivyd, Inc. (Nasdaq: IVVD) is a biopharmaceutical company devoted to delivering protection from serious viral infectious diseases, beginning with SARS-CoV-2.
Source: Invivyd, Inc.
