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.
You might also like
| 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
Alexa Deemer
Cantor Fitzgerald
2 questions for IVVD
Arabella
HC Wainwright
2 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 reported Q3 2025 PEMGARDA net product revenue of $13.1 million, representing 41% growth over Q3 2024 and 11% growth over Q2 2025.
- The company's cash and cash equivalents totaled $85.0 million at the end of Q3 2025, which increased to over $100 million by October 2025 after a public offering and at-the-market (ATM) facility usage.
- Invivyd has established a commercial foundation for PEMGARDA, with 811 accounts having infusion experience and 76% reordering accounts, and plans to scale this infrastructure for its VYD2311 candidate.
- The company is strategically positioning VYD2311 as a potential blockbuster monoclonal antibody, aiming to provide a non-vaccine alternative for COVID protection with anticipated high efficacy and long duration.
- Invivyd announced Q3 2025 financial results, with Pemgarda revenues growing 11% quarter-on-quarter and 41% year-over-year.
- The company received U.S. FDA feedback for its VYD2311 antibody, with pivotal clinical studies on track to initiate around year-end and deliver top-line data in mid-2026.
- Invivyd raised approximately $87 million in capital in Q3 2025 and shortly thereafter, making it well-capitalized through anticipated pivotal data for VYD2311 in mid-2026.
- The company stated it has no plans to actively sunset Pemgarda even after the potential approval of VYD2311.
- Invivyd reported Q3 2025 PEMGARDA revenues that increased 11% quarter-on-quarter and 41% year-over-year.
- The company successfully raised approximately $87 million in capital during Q3 2025 and shortly thereafter, ensuring it is well-capitalized through anticipated pivotal data for VYD2311 in mid-2026.
- Following FDA feedback, Invivyd is on track to initiate pivotal clinical studies for its VYD2311 antibody around year-end, with top-line data expected in mid-2026.
- Invivyd is expanding its commercial organization in preparation for the VYD2311 launch, while continuing to grow its PEMGARDA commercial franchise.
- Invivyd reported strong Q3 2025 financial results, with Pemgarda revenues increasing 11% quarter-on-quarter and 41% year-over-year.
- The company successfully raised approximately $87 million in capital, securing funding through anticipated pivotal data for VYD2311 in mid-2026.
- The pivotal clinical program for VYD2311 is on track to initiate around year-end, with top-line data expected in mid-2026, targeting a potential blockbuster market.
- Invivyd is expanding its commercial organization in preparation for the VYD2311 launch and is also pursuing early-stage discovery programs in RSV and measles, with an update expected before year-end.
- Invivyd reported PEMGARDA net product revenue of $13.1 million for Q3 2025, marking 41% growth year-over-year and 11% growth quarter-over-quarter.
- The company's cash and cash equivalents stood at $85.0 million as of September 30, 2025, with October 2025 ending cash exceeding $100 million following a $57.5 million public offering in August 2025 and an additional $29.8 million from an at-the-market offering in October 2025.
- Invivyd announced U.S. IND clearance and FDA alignment for VYD2311, a vaccine-alternative antibody for COVID, with its REVOLUTION pivotal clinical program expected to commence around year-end 2025 and top-line data anticipated mid-2026.
- Net loss for Q3 2025 significantly decreased to $10.5 million, compared to $60.7 million in Q3 2024, resulting in a basic and diluted net loss per share of $0.06.
- 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.