-- Achieved Q4 2025 PEMGARDA$(R)$ (pemivibart) net product revenue of $17.2 million, representing 25% growth year-over-year and 31% growth quarter-over-quarter -- 2025 year-end cash and cash equivalents of $226.7 million after raising over $200 million from financing transactions in 2H 2025 -- Announced initiation of DECLARATION Phase 3 pivotal clinical trial of vaccine-alternative antibody VYD2311 to prevent COVID, with top-line data expected mid-2026; Fast Track designation for VYD2311 granted by FDA in December 2025 -- DECLARATION trial on track with full enrollment achieved -- DECLARATION trial Independent Data Monitoring Committee (IDMC) prespecified review of unblinded VYD2311 safety data resulted in IDMC recommendation to allow enrollment of pregnant and breastfeeding women in the DECLARATION trial -- DECLARATION trial blinded, pooled early COVID event accumulation appears on track; any potential re-sizing decision to depend on trial progress but could occur in approximately April -- Distinguished scientist and physician Michael Mina, M.D., Ph.D., appointed Chief Medical Officer -- Management to host conference call today at 8:30AM ET
NEW HAVEN, Conn., March 05, 2026 (GLOBE NEWSWIRE) -- Invivyd, Inc. (Nasdaq: IVVD) today announced financial results for the fourth quarter and full year ended December 31, 2025, and recent business highlights.
"With potential commercialization of VYD2311 on the horizon, we are encouraged by continued commercial execution and appeal for monoclonal antibody prophylaxis demonstrated by revenue of PEMGARDA(R) (pemivibart) more than doubling year over year, while operating expenses were reduced by nearly half," noted Bill Duke, Chief Financial Officer of Invivyd. "While we are pleased with Invivyd's ability to exhibit financial discipline, we are most excited about the positive momentum behind VYD2311 and that our recent capital raises enable us to invest in the ongoing DECLARATION pivotal clinical trial and potential commercialization, if approved, in addition to our other pipeline programs."
"2026 is off to a busy start as we execute our pivotal VYD2311 program, expand our pipeline of monoclonal antibodies, and educate key stakeholders about the role monoclonal antibodies can and should play in the prevention of critical infectious diseases, beginning with COVID," commented Marc Elia, Chairman of the Invivyd Board of Directors. "We are pleased with the progress we've made and remain focused on creating medical value for patients and shareholders with molecules that can complement, provide alternative to, or synergize with vaccination across multiple pathogens. We look forward to sharing additional updates throughout the year."
Recent Business Highlights
-- Clinical & Regulatory Developments
-- Following trial initiation in late 2025, the DECLARATION pivotal
clinical trial recruitment has progressed rapidly with full
enrollment achieved.
-- The Independent Data Monitoring Committee (IDMC), responsible for
monitoring safety in the DECLARATION trial, recently completed its
prespecified review of unblinded safety data at an early timepoint,
as defined in the protocol, for VYD2311 in the DECLARATION trial
and returned 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.
-- Further 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; any potential trial up-sizing decision to support
statistical power will be based on overall progress and COVID
event rate using prespecified criteria, and could be decided upon
in approximately April.
-- In February 2026, Invivyd announced it received and was aligned
with advice from the U.S. Food and Drug Administration (FDA) on
the LIBERTY Phase 3 clinical trial, which will assess the safety
and immunologic profile of VYD2311, the company's
vaccine-alternative monoclonal antibody investigational candidate
for the prevention of COVID-19, versus commercially available mRNA
COVID vaccines.
-- LIBERTY is part of the company's broader REVOLUTION
clinical program designed to elaborate the profile of
monoclonal antibody-mediated prophylaxis from COVID-19 and
the potential medical benefits to vulnerable Americans.
-- The LIBERTY clinical trial 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.
-- The FDA, providing feedback jointly from CDER and CBER,
requested specific monitoring of adverse events of special
interest relevant to mRNA COVID vaccines, citing the known
risk of myocarditis/pericarditis in the young adult
population following mRNA COVID vaccination; no similar
requests have been made for other Invivyd clinical trials
without an mRNA COVID vaccine arm.
-- In January 2026, Invivyd and the SPEAR
(Spike Protein Elimination and Recovery) 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.
-- In December 2025, Invivyd announced the initiation of its
DECLARATION clinical trial.
-- DECLARATION is a Phase 3, randomized, placebo-controlled
clinical trial to evaluate the safety and efficacy of
VYD2311 in the prevention of COVID versus placebo, at three
months, from a single intramuscular (IM) dose.
-- A second arm will evaluate monthly IM doses versus placebo
to demonstrate the safety and efficacy of more frequent
dosing to support individual choice should at-risk persons
seek periodic extra protection from COVID.
-- The primary endpoint of DECLARATION is the reduction of
PCR-confirmed symptomatic COVID incidence versus placebo;
total expected enrollment of 1770 people across all three
arms.
-- DECLARATION is part of Invivyd's REVOLUTION clinical
program aimed at establishing monoclonal antibody
prophylaxis for prevention of COVID; top-line data are
expected mid-2026.
-- In the Phase 1/2 clinical trial, IM administered VYD2311,
at 4 times the planned dose in DECLARATION, was well
tolerated, with all adverse events (AEs) considered mild to
moderate in severity with no serious or severe AEs
reported; all AEs, including headache and injection site
pain, were deemed unrelated to study drug.
-- In December 2025, Invivyd announced that the FDA
granted Fast Track designation for VYD2311.
-- Fast Track is a process that enables the FDA to expedite
the development and review of new drugs that address a
serious or life-threatening condition and fill an unmet
medical need. If relevant criteria are met, programs with
Fast Track designation can become eligible for priority
review and rolling Biologics License Application (BLA)
submission, which can reduce the timelines associated with
regulatory action.
-- VYD2311 was granted Fast Track designation by the FDA for
the prevention of COVID in individuals with underlying risk
factors for severe COVID.
-- Pipeline Expansion
-- In November 2025, Invivyd announced selection of a potential
best-in-class Respiratory Syncytial Virus (RSV) antibody candidate
VBY329.
-- VBY329 is designed for the prevention of RSV infections in
newborns, infants, and children, and results from Invivyd's
proprietary antibody discovery platform.
-- VBY329 meets Invivyd's target profile of higher potency and
improved barrier to resistance compared to standard of care
RSV medicines, as assessed in vitro.
-- Invivyd expects to advance VBY329 toward IND readiness in
2H 2026 for development in pediatric RSV prophylaxis, a
blockbuster pharmaceutical market in 2024, expected to grow
to $3-$4 billion in annual revenues globally by 2030.
-- 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.
(MORE TO FOLLOW) Dow Jones Newswires
March 05, 2026 07:03 ET (12:03 GMT)
Comments