Invivyd CFO Highlights Strong Revenue Growth for PEMGARDA, Prepares for VYD2311 Launch
"We are pleased by strong top-line revenue growth of PEMGARDA(R) (pemivibart), which we believe is attributable to our commercial execution and the fundamental appeal of monoclonal antibody prophylaxis even in the face of declining COVID vaccination trends. We are actively preparing for the potential commercial launch of VYD2311, an accessible vaccine-alternative to prevent COVID, which, if approved, could represent a step-change from PEMGARDA, a specialty medicine for the immunocompromised," noted Bill Duke, Chief Financial Officer of Invivyd. "With a strong balance sheet bolstered by our recent capital raises, we are well-positioned to support the DECLARATION pivotal clinical trial and VYD2311 commercial launch, if approved, and look forward to trial enrollment during the anticipated upcoming peak season of COVID infections."
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- Stock Surge: Invivyd (IVVD) shares rose approximately 5% in premarket trading on Tuesday, reflecting positive market sentiment following the company's alignment with the FDA on the LIBERTY Phase 3 clinical trial, indicating increased investor confidence in its future prospects.
- Trial Design: The FDA has requested Invivyd to monitor myocarditis/pericarditis events associated with mRNA COVID-19 vaccines in the LIBERTY trial, a requirement that not only ensures trial safety but may also enhance market acceptance of VYD2311 as a potential preventative option for COVID-19.
- Trial Progress: Invivyd has initiated its registrational Phase 3 trial, DECLARATION, evaluating the efficacy of single or monthly dosing of VYD2311 in preventing symptomatic COVID-19, with topline data from 1,770 participants expected in mid-2026, which will provide crucial evidence for market launch.
- Market Outlook: The development of VYD2311 not only complements existing COVID-19 vaccines but may also offer a new preventative option for younger individuals, and as concerns about vaccine side effects grow, Invivyd's strategic position in the biopharmaceutical market is likely to strengthen.
- LIBERTY Trial Launch: Invivyd has announced the initiation of the LIBERTY Phase 3 clinical trial, designed to evaluate the safety and immunological profile of VYD2311 compared to mRNA COVID vaccines, with an expected enrollment of 210 participants to explore both standalone and co-administration effects.
- FDA Feedback and Monitoring Requirements: The FDA provided constructive feedback on the LIBERTY trial design and requested specific monitoring for adverse events of special interest related to mRNA vaccines, particularly myocarditis/pericarditis, highlighting concerns for the young adult population to ensure trial safety.
- Background on DECLARATION Trial: The LIBERTY trial builds on the previous DECLARATION trial, which is expected to enroll 1,770 participants to assess the efficacy and safety of VYD2311 in preventing symptomatic COVID, further validating its clinical application potential.
- Antibody Candidate VYD2311: VYD2311 is a novel monoclonal antibody aimed at providing prophylactic and therapeutic options for COVID-19, with pharmacokinetic properties that may allow for effective antibody levels through intramuscular administration, catering to patient-friendly needs.
- Trial Launch: Invivyd announced plans to initiate a Phase 2 clinical trial for VYD2311 targeting individuals with Long COVID and vaccine injury by mid-2026, addressing the urgent need for effective treatment options for millions suffering from persistent symptoms.
- Antibody Dose Design: The trial will utilize multiple high doses of monoclonal antibody VYD2311, which has demonstrated in vitro antiviral activity against all clinically recorded variants of SARS-CoV-2, potentially offering long-term therapeutic benefits for patients.
- Collaborative Research Group: Invivyd is partnering with the SPEAR Study Group to deepen the understanding of Long COVID biology and potential relief strategies, highlighting the focus on chronic infection and antigen persistence, which may open new avenues for treatment.
- Patient Recruitment Criteria: The trial will enroll patients with evidence of persistent infection or antigenemia, employing a double-blind placebo-controlled design to assess clinical efficacy and Patient-Reported Outcomes, ensuring scientific rigor and effectiveness of the study.
- Revenue Growth: Invivyd reported preliminary Q4 2025 net product revenue of $17.2 million for PEMGARDA® (pemivibart), reflecting a 25% year-over-year increase and a 31% quarter-over-quarter rise, indicating strong market demand for monoclonal antibody prophylaxis.
- Strong Financial Position: After raising over $200 million in the second half of 2025, Invivyd anticipates ending 2025 with cash and cash equivalents of $226.7 million, providing ample funding for upcoming clinical trials and potential product launches.
- Clinical Trial Initiation: The company initiated the DECLARATION Phase 3 clinical trial in December 2025 to evaluate the safety and efficacy of VYD2311 in preventing COVID, with top-line data expected in mid-2026, which could significantly enhance the company's market position in COVID prevention.
- Pipeline Expansion: Invivyd nominated the potential best-in-class RSV antibody candidate VBY329 for preclinical development, aiming for IND readiness in 2H 2026, targeting a blockbuster market projected to reach $3-4 billion in annual revenues globally by 2030.
- Fast Track Designation: Invivyd's VYD2311 has received FDA Fast Track designation aimed at providing COVID prevention for high-risk populations, which will expedite the clinical trial process and address the urgent market need for new vaccines.
- Clinical Trial Launch: The company has initiated the DECLARATION clinical trial, expecting to enroll 1,770 participants to evaluate the safety and efficacy of VYD2311, with successful completion paving the way for future Biologics License Application submissions.
- Vaccine Alternative: VYD2311 is a novel monoclonal antibody designed to provide effective prevention through a more patient-friendly intramuscular injection method, potentially enhancing patient experience and meeting market demand.
- Broad Market Potential: As COVID-19 continues to impact public health, the FDA's Fast Track designation not only enhances Invivyd's competitive position but may also boost investor confidence and future revenue prospects.

- Trial Launch: Invivyd has announced the initiation of the DECLARATION Phase 3 clinical trial, aiming to enroll 1770 participants to evaluate the safety and efficacy of VYD2311 in preventing COVID, marking a significant step towards a vaccine-alternative solution.
- Dosing Comparison Study: The trial will compare the effects of a single intramuscular injection versus monthly doses of VYD2311, aiming to provide flexible protection options for high-risk individuals, thereby enhancing personalized medical experiences for patients.
- Data Expectations: Top-line data from the trial are anticipated by mid-2026, which will provide critical support for VYD2311's Biologics License Application (BLA) and could potentially transform the treatment landscape for COVID prevention.
- Market Preparedness: Invivyd has prepared for the commercial production of VYD2311 and secured significant funding over the past four months to support the DECLARATION trial and potential market launch, demonstrating the company's strong commitment to combating COVID.









