Invivyd, Inc. (Nasdaq: IVVD) is a biopharmaceutical company dedicated to protecting individuals from serious viral infectious diseases, with an initial focus on SARS-CoV-2. The company leverages its proprietary INVYMAB™ platform to develop monoclonal antibodies (mAbs) that address evolving viral threats. Invivyd's primary product is PEMGARDA™, a monoclonal antibody authorized for emergency use in the prevention of COVID-19 in immunocompromised individuals.
- PEMGARDA™ - A monoclonal antibody authorized for emergency use by the FDA for pre-exposure prophylaxis (PrEP) of COVID-19 in adults and adolescents with moderate-to-severe immune compromise.
- VYD2311 - A monoclonal antibody candidate currently in early-stage clinical trials, aimed at addressing additional viral threats.
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| Name | Position | External Roles | Short Bio | |
|---|---|---|---|---|
Jill Andersen, J.D. Executive | Chief Legal Officer and Corporate Secretary | None | Leads legal and compliance functions. Previously held senior legal roles at Oyster Point Pharma, Bristol-Myers Squibb, and Celgene. | View Report → |
Julie Green, M.B.A. Executive | Chief Human Resources Officer (CHRO) | None | Heads HR strategy and employee engagement. Over 25 years of HR experience in life sciences. | View Report → |
Robert Allen, Ph.D. Executive | Chief Scientific Officer (CSO) | None | Oversees scientific direction and development of therapies, including monoclonal antibodies VYD222 and VYD2311. Previously held senior roles at SmartPharm Therapeutics and Sorrento Therapeutics. | View Report → |
Stacy Price, M.S. Executive | Chief Technology and Manufacturing Officer | None | Oversees technical operations and manufacturing. Previously held leadership roles at Akouos and Ziopharm Oncology. | View Report → |
Timothy Lee Executive | Chief Commercial Officer (CCO) | None | Leads commercial strategy, including PEMGARDA\u2122 launch. Previously held commercial leadership roles at Amylyx, Biohaven, and Alexion. | |
William Duke, Jr. Executive | Chief Financial Officer (CFO), Principal Financial Officer, Principal Accounting Officer, Interim Principal Executive Officer | None | Leads financial strategy and operations. Previously CFO at Apexigen, Kaleido Biosciences, and Pulmatrix. | |
Christine Lindenboom Board | Board Member | SVP of Investor Relations and Corporate Communications at Alnylam Pharmaceuticals; Board Member at Kendall Square Association | Nearly 25 years of experience in healthcare communications. Currently at Alnylam Pharmaceuticals. | |
Clive A. Meanwell, M.D. Board | Board Member | Executive Chair at Population Health Partners; Vice Chairman at BB Biotech; Board Member at EQRx, Fractyl Health, Comanche Biopharma, Saama, and Hugo Health | Co-founder of Population Health Partners. Extensive leadership in biotech and healthcare investments. | |
Marc Elia Board | Chairperson of the Board | Founder & CIO of M28 Capital; Board Member at Fractyl Health and SQZ Biotechnologies | Venture capitalist with expertise in healthcare investments. Founder of M28 Capital. Previously Partner at Bridger Capital. | |
Tamsin Berry Board | Board Member | Partner at Population Health Partners; Board Member at Global Pathogen Analysis Service; Advisor to University of Oxford Global Health Security Consortium | Former Director of U.K. Office for Life Sciences. Awarded OBE for contributions to COVID-19 response. | |
Terrance McGuire Board | Board Member | Founding Partner at Polaris Partners; Board Member at Cyclerion, Seer, and Adimab; Advisor to Dartmouth and MIT | Venture capitalist with extensive experience in biotech investments. Founding Partner of Polaris Partners. |
- Given the recent FDA warning and the confusion it caused among healthcare providers and patients regarding PEMGARDA's efficacy, what specific steps are you taking to rebuild trust and mitigate similar risks in the future?
- You withdrew your revenue guidance of $150 million to $200 million due to recent headwinds; with modest net product revenue growth, what gives you confidence in achieving profitability by the end of June 2025?
- With anticipated significant reductions in R&D expenses and manufacturing costs, how will this impact the development and regulatory timelines of your next-generation antibody, VYD2311?
- Can you elaborate on how seasonality affects PEMGARDA's sales, and what adjustments are you making in your commercial strategy to account for the non-seasonal nature of COVID-19 among immunocompromised patients?
- Considering the challenges posed by SARS-CoV-2 variants and potential reduction in antibody efficacy, how are you leveraging your technology to develop antibodies with enhanced potency and durability to address future virus variations?
Research analysts who have asked questions during Invivyd earnings calls.
Patrick Trucchio
H.C. Wainwright & Co.
5 questions for IVVD
Maxwell Skor
H.C. Wainwright & Co.
3 questions for IVVD
Jason Kolbert
D Boral Capital
2 questions for IVVD
Jenna Li
Jefferies
2 questions for IVVD
Michael Yee
Jefferies
2 questions for IVVD
Evan Wang
Guggenheim Securities
1 question for IVVD
Kaiyue Yang
Jefferies
1 question for IVVD
| Customer | Relationship | Segment | Details |
|---|---|---|---|
Third-Party Logistic Distribution Agent | Provides storage, distribution, and logistics services | All | 19% of total gross sales in 2024 |
Specialty Distributor #1 | Distribution of product | All | 42% of total gross sales in 2024 |
Specialty Distributor #2 | Distribution of product | All | 24% of total gross sales in 2024 |
Specialty Distributor #3 | Distribution of product | All | 13% of total gross sales in 2024 |
Recent press releases and 8-K filings for IVVD.
- Invivyd, Inc. filed an 8-K on October 30, 2025, announcing the posting of an investor presentation detailing its pipeline and clinical programs.
- The company is committed to developing best-in-class antibody protection and treatment for viral threats, including COVID (PEMGARDA® and VYD2311), Long COVID, RSV, and Measles.
- The VYD2311/REVOLUTION Clinical Program is advancing, with Phase 1/2 data demonstrating attractive safety for VYD2311 at high doses. The pivotal 'DECLARATION' study aims for a 70%-90% reduction in symptomatic COVID with a single 250 mg IM dose, leveraging VYD2311's 76-day half-life for potential long-term protection.
- Invivyd is undertaking launch preparations for its product candidates, including PEMGARDA® and VYD2311, pending regulatory approvals, and notes broad recognition for antibodies in COVID from various medical societies and guidelines.
- Invivyd is advancing its REVOLUTION clinical program for the COVID-19 monoclonal antibody (mAb) candidate VYD2311, which includes the DECLARATION Phase 3 trial to prevent symptomatic COVID and the LIBERTY Phase 3 trial for safety/tolerability and co-administration with mRNA vaccines.
- The DECLARATION trial aims for a 70%-90% reduction in symptomatic COVID over three months with a single 250 mg intramuscular dose of VYD2311, which has demonstrated a long half-life of 76 days.
- Initial Phase 1/2 study data for VYD2311 showed attractive safety at high doses, with no deaths, serious adverse events (SAEs), or severe treatment-emergent adverse events (TEAEs) reported.
- The company highlights the ability of mAbs like VYD2311 and PEMGARDA (pemivibart) to be engineered for consistent high activity against SARS-CoV-2 variants, contrasting with the perceived limitations of COVID vaccines. PEMGARDA is also undergoing launch preparation for pre-exposure prophylaxis (PrEP) of COVID-19 in certain immunocompromised patients.
- Invivyd provided an update on its Revolution Clinical Program for VYD2311, an antibody being developed as an alternative to COVID vaccination, highlighting its potential to offer better, safer protection from infectious diseases.
- The Phase 1/2 study for VYD2311 was completed, demonstrating that the drug was generally safe and well-tolerated even at extremely high doses.
- The pivotal Declaration study (Phase 3) is a randomized, placebo-controlled trial designed to assess VYD2311's ability to reduce the risk of symptomatic COVID-19, with an expected 70% to 90% reduction over a 90-day period for a single 250 mg intramuscular dose. The study is also designed to show greater than 50% protection out to one year.
- Invivyd is also planning the Liberty study to compare the safety and tolerability of VYD2311 against mRNA vaccines and to assess the impact of combining them.
- The company sees an enormous commercial opportunity for VYD2311, citing U.S. COVID vaccine sales of $3.8 billion in 2024, and expects VYD2311 to be reimbursed by Medicare Part B and D.
- Invivyd, Inc. announced U.S. IND Clearance and alignment with the U.S. FDA for the pivotal clinical program of VYD2311, a vaccine-alternative antibody to prevent COVID.
- The DECLARATION (Phase 3) and LIBERTY clinical trials are expected to begin around year-end 2025, with top-line data anticipated mid-2026.
- Invivyd has commercial launch quantities of VYD2311 at-the-ready and has secured capital to fund the clinical trials through pivotal data readouts.
- Invivyd is a commercial stage company with PEMGARDA, an authorized COVID-19 monoclonal antibody for immunocompromised individuals, which has faced logistical challenges as a quarterly high-dose infusion.
- The company is developing VYD2311, a next-generation monoclonal antibody designed as a vaccine alternative for COVID-19, aiming for low-dose, high-efficacy, high-safety, and high-durability.
- Invivyd is pursuing a full Biologics License Application (BLA) for VYD2311, targeting Americans 12 and up, with feedback from the FDA suggesting a rapid path forward.
- VYD2311 is expected to offer significant advantages over vaccines in efficacy (70-90% protection), safety (no inflammatory reactogenicity), and durability, with anticipated COGS below $100 and a price point in the hundreds of dollars.
- A positive ACIP recommendation for VYD2311 would enable it to be free with no out-of-pocket cost for a large portion of the American population, significantly simplifying commercialization.
- Invivyd, Inc. closed its public offering on August 22, 2025.
- The offering included 89,234,480 shares of common stock at $0.52 per share and 21,342,442 pre-funded warrants at $0.5199 per pre-funded warrant.
- The company received approximately $57.5 million in gross proceeds and approximately $53.5 million in net proceeds from the offering.
- Invivyd intends to use the net proceeds for the VYD2311 clinical program, research and development for pipeline programs such as respiratory syncytial virus (RSV) and measles, advancement of SPEAR Study Group efforts related to Long COVID and COVID-19 Post-Vaccination Syndrome, and for working capital and general corporate purposes.
- Invivyd Inc. reported $11.8 million in PEMGARDA net product revenue for Q2 2025.
- Operating expenses for Q2 2025 were $26.2 million, a reduction from previous quarters, and the company ended Q2 2025 with approximately $34.9 million in cash and cash equivalents.
- The company's goal of near-term profitability (1H 2025) was not met, but remains possible with the upcoming respiratory virus season expected to contribute to topline.
- Invivyd announced full Phase 1/2 clinical data for VYD2311 in June 2025, a next-generation monoclonal antibody for COVID-19 prevention, and aims for a Biologics License Application (BLA) pathway.
- The company is also advancing its pipeline with RSV and Measles programs in discovery phases, with updates anticipated in Q3 2025 for RSV and by end of 2025 for Measles.
- Invivyd, Inc. reported Q2 2025 PEMGARDA net product revenue of $11.8 million, representing 413% growth year-over-year compared to $2.3 million in Q2 2024.
- The company's net loss for Q2 2025 was $14.7 million, or $0.12 per share, an improvement from a net loss of $47.2 million, or $0.40 per share, in Q2 2024.
- Invivyd announced alignment with the U.S. FDA on a rapid pathway to full approval (BLA) for its vaccine alternative monoclonal antibody candidate VYD2311 for COVID-19 prevention, following positive Phase 1/2 clinical data.
- The company's target of near-term profitability (1H 2025) was not met, though it remains possible with the upcoming respiratory virus season.
- Invivyd, Inc. announced the formation of the SPEAR (Spike Protein Elimination and Recovery) Study Group with leading researchers on July 2, 2025, to assess the effects of monoclonal antibody therapy for Long COVID and COVID-19 Post-Vaccination Syndrome.
- This initiative was prompted by anecdotal reports of meaningful symptom relief in Long COVID patients following the use of PEMGARDA® (pemivibart), which is currently authorized by the FDA for pre-exposure prophylaxis of COVID-19 but not for the treatment of Long COVID.
- The SPEAR Study Group will structure and guide anticipated clinical trials to evaluate the effects of broadly neutralizing anti-SARS-CoV-2 spike protein monoclonal antibody therapy, including next-generation candidates like VYD2311, in relevant patient populations.
- Invivyd plans to meet with the FDA early in Q3 2025 to discuss rapid approval pathways for COVID-19 monoclonal antibodies.
- Invivyd announced positive full Phase 1/2 clinical data for VYD2311, a next-generation COVID-19 monoclonal antibody, demonstrating an attractive safety profile with all reported adverse events deemed unrelated or classified as mild to moderate, and no serious or severe adverse events observed.
- Following a single dose, serum concentrations of VYD2311 remained high at six months, with the intramuscular (IM) dose route having the longest observed half-life at 76.0 days. This long half-life could allow meaningful, long-term protection.
- Comprehensive dose modeling of VYD2311 indicates possible strong protection from symptomatic COVID-19 achievable via IM dosing on a long interval (months to quarters and beyond).
- A Type C meeting is scheduled with the FDA for early Q3 2025 to discuss registration-directed next steps for the VYD2311 program and overall approval pathway for Invivyd COVID-19 monoclonal antibodies.