Highest-materiality recent filing
Invivyd's VYD2311 bests COMIRNATY on safety in LIBERTY Phase 3; BLA via Accelerated Approval planned
LIBERTY randomized 210 healthy adults (18-49) 1:1:1 to 250mg VYD2311, COMIRNATY mRNA vaccine, or both; VYD2311 met all primary and secondary endpoints.
Invivyd names Chairman Marc Elia CEO; VYD2311 data expected end of Q3 2026
Marc Elia, former Chairman, appointed CEO effective Aug 30, 2026; retains Chairman role.
Invivyd Q2 2026 revenue up 21% to $14.3M; net loss widens to $44.4M; PEMGARDA EUA termination notice
Q2 2026 PEMGARDA net product revenue $14.3M, up 21% YoY from $11.8M.
Nasdaq notified Invivyd on July 23, 2026 that its common stock bid price closed below $1.00 for 30 consecutive business days.
FDA sent Invivyd Notice of Termination for PEMGARDA EUA, effective June 29, 2027, following HHS termination of COVID-19 EUA declaration.
Invivyd shareholders elect all six director nominees, ratify PwC as auditor
All six director nominees elected at May 19, 2026 annual meeting: Tamsin Berry, Paul B. Bolno, M.D., Marc Elia, Terrance McGuire, Kevin F. McLaughlin, Ajay Royan.
Invivyd Q1 net product revenue $13.7M (+22% YoY); net loss $41.4M; VYD2311 data delayed to Q3 2026
Q1 2026 PEMGARDA net product revenue $13.7M, up 22% YoY vs $11.3M.
Invivyd announces Phase 3 DECLARATION upsizing; new measles antibody VMS063
DECLARATION Phase 3 COVID-19 prophylaxis study upsized by ~500 subjects; top-line results now expected in Q3 2026, shifted from mid-2026.
Q4 2025 PEMGARDA net revenue $17.2M (up 25% YoY, 31% QoQ); FY2025 revenue $53.4M vs $25.4M in 2024.
Preliminary Q4 2025 PEMGARDA net product revenue of $17.2M, up 25% YoY from $13.8M and 31% QoQ from $13.1M.
Invivyd receives FDA Fast Track designation for COVID antibody VYD2311
FDA Fast Track granted for VYD2311 to prevent COVID in individuals with risk factors for severe disease.
Invivyd selects RSV antibody candidate VBY329; 2H 2026 IND readiness targeted
VBY329 showed 1.5x greater potency vs nirsevimab, 1.2x vs clesrovimab against authentic RSV strains.
Invivyd prices $125M stock and warrant offering; net proceeds ~$117.2M for pipeline funding
Priced 44M shares at $2.50 and 6M pre-funded warrants at $2.4999; gross $125M, net ~$117.2M.
Invivyd Q3 revenue $13.1M (+41% YoY); net loss narrows; IND cleared for VYD2311
PEMGARDA net product revenue $13.1M in Q3 2025, up 41% YoY and 11% QoQ.
Invivyd posts investor presentation on website; no substantive details provided in filing
Filing states investor presentation posted on Oct 30, 2025 at www.invivyd.com.
Invivyd announces FDA IND clearance for VYD2311; Phase 3 and Phase 2 trials to start year-end 2025
FDA cleared IND and aligned on pivotal clinical program for VYD2311, a vaccine-alternative monoclonal antibody to prevent COVID.
Invivyd appoints Paul B. Bolno, M.D. to board; regains Nasdaq compliance
Dr. Bolno, President and CEO of Wave Life Sciences, appointed to Board and Compensation Committee effective September 22, 2025.
Invivyd closes $57.5M public offering; net proceeds ~$53.5M for pipeline development
Raised ~$57.5M gross ($53.5M net) via 89.2M shares at $0.52/sh and 21.3M pre-funded warrants at $0.5199.
Invivyd aligns with FDA on rapid BLA pathway for VYD2311; Q2 revenue $11.8M, up 413% YoY
Q2 2025 PEMGARDA net product revenue $11.8M, up 413% YoY; net loss $14.7M ($0.12/sh) vs $47.2M ($0.40/sh) in Q2 2024.
Invivyd forms SPEAR Study Group with top researchers to test mAbs for Long COVID
SPEAR Study Group includes Drs. Michael Peluso, Amy Proal, David Putrino; will evaluate PEMGARDA and VYD2311.
Invivyd reports positive Phase 1/2 data for VYD2311 COVID-19 mAb; half-life up to 76 days
All adverse events mild to moderate; no serious or severe AEs observed across IV, SC, and IM routes.
Invivyd stockholders elect six directors, ratify PwC as auditor at 2025 annual meeting
All six director nominees elected; Marc Elia received ~3.3M withheld votes, others below 2.4M.
Invivyd Q1 net revenue $11.3M; net loss narrows to $16.3M; targets 1H 2025 profitability
PEMGARDA net product revenue of $11.3M in Q1 2025, down from $13.8M in Q4 2024 due to sales force transition; re-acceleration seen in Q2 2025.
Invivyd launches discovery program for measles monoclonal antibody; candidate target by 2025
Multiple healthcare providers have requested a monoclonal antibody for measles treatment and post-exposure prophylaxis from Invivyd.
Invivyd receives Nasdaq bid price deficiency notice; compliance period ends Oct 20, 2025
Received Nasdaq deficiency letter on April 21, 2025 for bid price closing below $1.00 for 30 consecutive business days.
Invivyd secures $30M non-dilutive term loan facility with Silicon Valley Bank
Up to $30M term loan facility split into three $10M tranches available upon meeting financial covenants and net product revenue milestones.
Invivyd appoints Ajay Royan (Mithril Capital) to Board of Directors
Royan appointed effective March 22, 2025; term expires at 2025 annual meeting.
Q4 2024 net product revenue $13.8M, up 48% from Q3 $9.3M; full-year 2024 net product revenue $25.4M.
Invivyd reports PEMGARDA neutralizes dominant SARS-CoV-2 variant LP.8.1
New in vitro data show PEMGARDA (pemivibart) neutralizes dominant LP.8.1 variant, consistent with prior variants.
FDA declined expansion of PEMGARDA EUA for mild-to-moderate COVID-19 treatment in immunocompromised patients with no alternative options.
Invivyd reports preliminary Q4 revenue of $13.8M; positive Phase 1/2 data for VYD2311
Preliminary Q4 PEMGARDA net revenue $13.8M, 48% growth over Q3; total operating costs $32M, 55% reduction.
Invivyd submits XEC variant data to FDA supporting pemivibart treatment EUA amendment
Updated immunobridging analysis with XEC variant shows pemivibart titers substantially exceed adintrevimab in Days 0-5.
Invivyd announces PEMGARDA neutralizes dominant SARS-CoV-2 variant XEC in vitro
New data show PEMGARDA (pemivibart) maintains neutralizing activity against XEC, which with KP.3.1.1 accounts for 69% of U.S. variants per CDC.
Invivyd receives Nasdaq deficiency notice for bid price below $1.00 share
Received deficiency letter on 12/27/2024; stock bid price <$1.00 for 30 consecutive business days.
Director Sara Cotter resigns from Invivyd board effective November 27
Sara Cotter notified her resignation from the Board of Directors and all committees, effective immediately on November 27, 2024.
Invivyd Q3 2024 net product revenue $9.3M but net loss widens to $60.7M; cash $106.9M
PEMGARDA net product revenue $9.3M, up from $2.3M in Q2 2024; not at previously anticipated rates.
Preliminary Q3 2024 PEMGARDA net product revenue of $9.3M; cash and equivalents ~$107M as of Sept 30.
In vitro neutralization potency of PEMGARDA against KP.3.1.1 and LB.1 variants remains in-line with prior predominant variants dating to 2022.
Invivyd posts updated corporate presentation; no specific new details disclosed
Corporate presentation dated September 6, 2024 posted on company website and furnished as Exhibit 99.1.
Invivyd doses first participants in Phase 1 trial of COVID-19 mAb candidate VYD2311
Phase 1 trial (NCT06523153) of VYD2311 dosed first healthy volunteers; placebo-controlled, randomized.
Invivyd announces PEMGARDA neutralizing activity against dominant variants KP.3.1.1 and LB.1
New in vitro data show PEMGARDA neutralizes KP.3.1.1 (42.2% of US cases) and LB.1 variants.
84% relative risk reduction vs placebo (1.9% vs 11.9% symptomatic COVID-19 rate, p=0.000061) over 180 days in immunocompetent cohort.
Invivyd reports Q2 2024 net product revenue of $2.3M, expects 2024 revenue of $150-200M
PEMGARDA launched commercially in Q2 2024 with $2.3M net product revenue; early Q3 commercial acceleration noted.
Invivyd announces VYD222 shows neutralizing activity against KP.1.1 and KP.3 SARS-CoV-2 variants
VYD222 demonstrated in vitro neutralization of KP.1.1 FLiRT and KP.3 variants in pseudovirus assays.
Interim CEO departs, CFO takes PEO role, new CCO, FDA immunobridging path
Jeremy Gowler ceases as interim CEO, COO, CCO effective May 30; employment ends June 29.
Invivyd elects two new independent directors at annual meeting
Dr. Srishti Gupta and Kevin F. McLaughlin elected to board on May 21, 2024.
Invivyd Q1 net loss $43.5M ($0.38/sh); launches PEMGARDA, guides 2024 rev $150-200M
Launched PEMGARDA (pemivibart) for COVID-19 PrEP in immunocompromised; received CMS HCPCS Q and M codes.
Invivyd to pursue EUA for pemivibart for COVID-19 treatment in immunocompromised
Plans EUA submission for pemivibart to treat mild-to-moderate COVID-19 in moderately-to-severely immunocompromised people via immunobridging pathway.
Invivyd CEO David Hering departs; Jeremy Gowler appointed Interim CEO
Dave Hering ceased as CEO and director effective April 11, 2024; employment ends May 11, 2024; Board searching for permanent CEO.
Invivyd announces PEMGARDA commercial launch, 2024 revenue guidance $150M-$200M
PEMGARDA now commercially available in the U.S. for COVID-19 PrEP in immunocompromised adults/adolescents.
On August 30, 2026, the Board of Directors (the “Board”) of Invivyd, Inc. (the “Company”) appointed Marc Elia, Chairman of the Board, as the Company’s Chief Executive Officer, effective as of August 30, 2026
Mr. Elia will serve as the Company’s principal executive officer, a role previously held by William Duke, Jr., the Company’s Chief Financial Officer, who remains the Company’s principal financial officer and principal accounting officer.
the Board appointed Ajay Royan as the Lead Independent Director of the Board, effective as of the Effective Date.
On March 22, 2025, the Board of Directors (the “Board”) of Invivyd, Inc. (the “Company”), upon the recommendation of the Nominating and Corporate Governance Committee of the Board, appointed Ajay Royan as a director, effective immediately, with his term expiring at the Company’s 2025 annual meeting of stockholders.
On November 27, 2024, Sara Cotter notified Invivyd, Inc. (the “Company”) of her decision to resign from the Board of Directors of the Company and all committees thereof, effective immediately.
Effective May 30, 2024, William Duke, Jr., the Company’s Chief Financial Officer, will serve as the Company’s “principal executive officer”.
Jeremy Gowler, the Interim Chief Executive Officer, Chief Operating Officer and Chief Commercial Officer of Invivyd, Inc. (the “Company”), ceased serving as an executive officer and as the Company’s “principal executive officer,” effective as of May 30, 2024, with his employment terminating on June 29, 2024.
the Board appointed Jeremy Gowler, the Company's current Chief Operating Officer and Chief Commercial Officer, as the Company's Interim Chief Executive Officer
Mr. Hering has also resigned from the Board pursuant to the terms of the Hering Employment Agreement.
On February 5, 2024, Tomas Heyman, a member of the Board of Directors of Invivyd, Inc. (the “Company”), informed the Company of his decision not to stand for re-election when his term expires at the Company’s 2024 annual meeting of stockholders.
On September 5, 2023, Invivyd, Inc. (the “Company”) announced the appointment of William Duke, age 51, as the Company’s Chief Financial Officer, effective as of September 1, 2023
appointed Sara Cotter as a director to fill the resulting vacancy, effective immediately
Max materiality 0.85 · Median 0.70 · Most common event other_material