Invivyd Receives FDA Guidance for LIBERTY Phase 3 Trial
Written by Emily J. Thompson, Senior Investment Analyst
Updated: 5d ago
0mins
Should l Buy IVVD?
Invivyd received and is aligned with advice from the U.S. Food and Drug Administration 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. The trial will also explore the safety and immunologic profile of VYD2311 and mRNA COVID vaccine administered simultaneously. The Centers for Disease Control and Prevention surveyed Americans who had not received a COVID booster during the 2023-2024 season, and the main reason, among others, identified was concern about serious or unknown side effects. Citing known risk of myocarditis/pericarditis in young adult Americans who take the mRNA COVID vaccine, the FDA requested Invivyd specifically monitor for these adverse events of special interest in this LIBERTY trial, which includes mRNA vaccination. No such request has been conveyed for DECLARATION or other Invivyd monoclonal antibody clinical trials without an mRNA COVID vaccine arm. Further, myocarditis and pericarditis have not been observed in any Invivyd clinical trial, nor have myocarditis and pericarditis been observed in postmarketing Adverse Event reports for pemivibart. Invivyd previously announced initiation of DECLARATION, the company's Biologics License Application-enabling clinical trial of VYD2311. DECLARATION is a Phase 3, randomized, triple-blind, placebo-controlled trial to evaluate VYD2311 safety and efficacy in prevention of symptomatic COVID in a broad population of participants including adults and adolescents both with and without underlying risk factors for progression to severe COVID-19, at three months. Participants will receive either a single dose or a monthly dose of VYD2311, each administered via intramuscular injection, compared to placebo. Total enrollment of the trial is expected to be 1770 participants. Top-line data from the trial are expected mid-2026.
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Analyst Views on IVVD
Wall Street analysts forecast IVVD stock price to rise over the next 12 months. According to Wall Street analysts, the average 1-year price target for IVVD is 10.00 USD with a low forecast of 10.00 USD and a high forecast of 10.00 USD. However, analyst price targets are subjective and often lag stock prices, so investors should focus on the objective reasons behind analyst rating changes, which better reflect the company's fundamentals.
4 Analyst Rating
3 Buy
1 Hold
0 Sell
Strong Buy
Current: 1.710
Low
10.00
Averages
10.00
High
10.00
Current: 1.710
Low
10.00
Averages
10.00
High
10.00
About IVVD
Invivyd, Inc. is a biopharmaceutical company. The Company’s proprietary INVYMAB platform approach combines state-of-the-art viral surveillance and predictive modeling with advanced antibody engineering. INVYMAB is designed to facilitate the rapid, serial generation of new monoclonal antibodies (mAbs) to keep pace with evolving viral threats. The Company delivers antibody-based therapies that protect vulnerable people from the devastating consequences of circulating viral threats, such as SARS-CoV-2. Its PEMGARDA (pemivibart) is the Company's first mAb to receive regulatory authorization and is designed to keep pace with SARS-CoV-2 viral evolution. PEMGARDA is used for the pre-exposure prophylaxis (prevention) of COVID-19 in adults and adolescents. Its VYD2311 is optimized for neutralization potency against SARS-CoV-2 lineages such as BA.2.86 and JN.1. The Company also has additional anti-SARS-CoV-2 mAb candidates in discovery and pre-clinical characterization.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
Invivyd Aligns with FDA on LIBERTY Phase 3 Trial for VYD2311
- 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.
See More
Invivyd Launches LIBERTY Clinical Trial for VYD2311
- 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.
See More
Invivyd Initiates Phase 2 Trial for VYD2311 Targeting Long COVID Patients
- 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.
See More
Invivyd Reports Q4 2025 Revenue of $17.2M, Up 25% Year-over-Year
- 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.
See More
Invivyd Receives FDA Fast Track Designation for VYD2311 Vaccine
- 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.
See More
Invivyd Initiates Phase 3 DECLARATION Trial for VYD2311 with 1770 Participants
- 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.
See More
Invivyd Aligns with FDA on LIBERTY Phase 3 Trial for VYD2311
- 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.
See More
Invivyd Launches LIBERTY Clinical Trial for VYD2311
- 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.
See More
Invivyd Initiates Phase 2 Trial for VYD2311 Targeting Long COVID Patients
- 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.
See More
Invivyd Reports Q4 2025 Revenue of $17.2M, Up 25% Year-over-Year
- 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.
See More
Invivyd Receives FDA Fast Track Designation for VYD2311 Vaccine
- 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.
See More
Invivyd Initiates Phase 3 DECLARATION Trial for VYD2311 with 1770 Participants
- 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.
See More
