Invivyd Receives FDA Fast Track Designation for VYD2311 Vaccine
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Dec 23 2025
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Source: Globenewswire
- 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.
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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: 1.920
Low
10.00
Averages
10.00
High
10.00
Current: 1.920
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 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.
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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.
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