Every 8-K that Invivyd, Inc. (IVVD) has filed with the SEC in the last 24 months is listed below, newest first, and each one links through to the document itself with the summary and the scores our analysis gives it.
A 8-K covers material events a company has to report between its quarterly reports, so if you follow IVVD and want that one kind of document rather than the whole filing history, this is the page to keep. The company's other filings, of every form, are on the full IVVD filings page.
Invivyd, Inc. (IVVD) announced leadership and governance changes and provided an update on its COVID-19 antibody program. The board appointed Chairman Marc Elia as Chief Executive Officer effective August 30, 2026, with CFO William Duke, Jr. continuing as principal financial and accounting officer. Elia’s employment agreement includes a substantial option grant, cash compensation, and change-in-control protections. The board named Ajay Royan Lead Independent Director and added Ian Sheffield as an independent director, who joined the Audit and Compensation Committees. Invivyd also highlighted that its Phase 3 VYD2311 studies, DECLARATION and LIBERTY, are approaching completion, with top-line data from VYD2311 expected around the end of Q3 2026 and potential Biologics License Application filings under either traditional or Accelerated Approval pathways, subject to FDA review.
Invivyd, Inc. reported second quarter 2026 PEMGARDA net product revenue of $14.3 million, up 21% from $11.8 million in Q2 2025, driven by increased patient demand. Cash and cash equivalents were $160.1 million as of June 30, 2026, which the company anticipates will fund operations through the DECLARATION pivotal data readout and potential VYD2311 launch readiness.
R&D expenses rose to $29.4 million from $9.6 million, and SG&A expenses increased to $29.5 million from $16.6 million, contributing to a wider net loss of $44.4 million versus $14.7 million a year earlier. Enrollment in the pivotal DECLARATION and Phase 3 LIBERTY VYD2311 trials is complete, with top-line data expected in late Q3 2026. Invivyd is also advancing VMS063 for measles and VBY329 for RSV, while PEMGARDA remains under EUA with a 12‑month termination notice issued in July 2026.
Invivyd, Inc. disclosed that it received a Nasdaq deficiency letter because its common stock failed to meet the $1.00 per share minimum bid price requirement for 30 consecutive business days for listing on The Nasdaq Global Market.
The company has until January 19, 2027 to regain compliance by having a closing bid of at least $1.00 for a minimum of ten consecutive business days, subject to Nasdaq’s discretion to extend that period. If compliance is not regained, Invivyd may seek a second 180‑day compliance period by transferring to the Nasdaq Capital Market and meeting other listing criteria, but its stock could ultimately be subject to delisting, with only a right to appeal to a Nasdaq Hearings Panel. Invivyd plans to monitor its share price and consider available options but provides no assurance it will regain compliance.
Invivyd, Inc. reported that the U.S. Food and Drug Administration has issued a Notice of Termination for the Emergency Use Authorization (EUA) of its COVID-19 monoclonal antibody PEMGARDA, with termination effective on June 29, 2027, following an HHS decision to end the COVID-19 EUA declaration.
PEMGARDA will remain authorized during a twelve-month transition period while Invivyd continues discussions with FDA on potential next steps and a possible Biologics License Application. The company emphasizes PEMGARDA’s role in pre-exposure COVID-19 prevention for moderately to severely immunocompromised patients and highlights existing clinical, safety, and real-world use data.
Invivyd, Inc. reported voting results from its Annual Meeting of Stockholders held on May 19, 2026. Stockholders elected six directors — Tamsin Berry, Paul B. Bolno, M.D., Marc Elia, Terrance McGuire, Kevin F. McLaughlin and Ajay Royan — each for a one-year term ending at the 2027 annual meeting.
Each director nominee received over 173 million votes in favor, with additional broker non-votes recorded. Stockholders also ratified PricewaterhouseCoopers LLP as Invivyd’s independent registered public accounting firm for the fiscal year ending December 31, 2026, with 222,576,623 votes for, 80,390 against and 44,315 abstentions.
Invivyd, Inc. reported first quarter 2026 results showing growing product sales alongside higher spending as it advances its COVID-19 antibody pipeline. Net product revenue reached $13.7 million, up from $11.3 million a year earlier, driven by continued uptake of PEMGARDA for immunocompromised patients.
Total operating costs and expenses rose to $56.9 million, largely from research and development and commercial build-out, leading to a net loss of $41.4 million compared with a $16.3 million loss in the prior-year quarter. Cash and cash equivalents were $184.2 million as of March 31, 2026, supplemented by additional ATM proceeds in April.
The company highlighted rapid enrollment in its DECLARATION Phase 3 pivotal study of VYD2311, plans for the LIBERTY safety and combination trial with an mRNA COVID vaccine, and a pediatric program design agreed with the FDA. Invivyd is also advancing earlier-stage antibodies targeting measles (VMS063) and RSV (VBY329) while expanding commercial infrastructure for a potential VYD2311 launch.
Invivyd, Inc. provides detailed updates on its COVID-19 antibody program and unveils a new measles antibody candidate. The pivotal Phase 3 DECLARATION study of VYD2311 for pre-exposure COVID-19 prophylaxis has been upsized by about 500 participants beyond an initial 1,818, after a pre-specified, conservative, blinded sample size re-estimation showed enough events to support high-end efficacy targets. Top-line data are now expected in the third quarter of 2026, with a pediatric VYD2311 study in children 0–11 years, called DRUMMER, planned only if DECLARATION is successful. Invivyd also introduces VMS063, a highly potent, half-life-extended measles monoclonal antibody targeting the conserved Fusion protein, showing picogram- to low-nanogram-per-milliliter neutralization in vitro across key measles lineages. VMS063 has entered IND-enabling work for near-term clinical development, aimed at treatment and prophylaxis in high-risk groups amid rising U.S. measles cases and waning herd immunity.
Invivyd, Inc. reported strong 2025 growth as net product revenue rose to $53.4M from $25.4M, driven by PEMGARDA sales, while operating expenses fell sharply. The company’s net loss narrowed to $52.5M from $169.9M, and year-end cash and equivalents increased to $226.7M, supported by over $200M raised in the second half of 2025.
PEMGARDA quarterly net product revenue reached $17.2M in Q4 2025, up 25% year over year and 31% sequentially, helping build a commercial foundation. Invivyd advanced its pipeline, fully enrolling the Phase 3 DECLARATION trial of COVID-19 antibody VYD2311, gaining Fast Track designation and targeting top-line data mid-year, while nominating RSV candidate VBY329 and planning a SPEAR Long COVID study.
Invivyd, Inc. filed a current report describing a new press release that shares preliminary fourth quarter 2025 PEMGARDA® (pemivibart) net product revenue and the company’s cash and cash equivalents as of December 31, 2025. These figures are early management estimates and may change after Invivyd completes its financial closing procedures and finalizes its audited financial statements for the quarter and full year 2025.
The company explains that the preliminary data have not been audited by its independent registered public accounting firm and that additional information will be needed for a full picture of its financial position and results of operations. Invivyd also filed the full press release as an exhibit and made an updated corporate presentation available on its website, providing investors with recent business highlights alongside the early financial indicators.
Invivyd, Inc. reported that it has issued a press release announcing the selection of RSV antibody candidate VBY329, which it describes as a potential best-in-class therapy. The company stated in the release title that it is targeting investigational new drug (IND) readiness for this candidate in the second half of 2026, signaling a planned next step toward clinical development. This update was furnished as an informational 8-K under Other Events, along with the full press release as an exhibit.
Invivyd, Inc. entered into an underwriting agreement for an underwritten public offering of 44,000,000 shares of common stock and pre-funded warrants to purchase 6,000,000 shares. The shares were priced at $2.50 each and the pre-funded warrants at $2.4999, with an option for underwriters to buy up to an additional 7,500,000 shares at the same price. The company reports net proceeds of approximately $117.2 million after fees, and the offering closed on November 19, 2025.
Invivyd plans to use the proceeds, together with existing cash, to prepare commercially for the potential launch of VYD2311, continue research and development for programs such as RSV and measles, advance its SPEAR Study Group work on Long COVID and COVID-19 Post-Vaccination Syndrome, and for working capital and general corporate purposes. The pre-funded warrants are exercisable immediately, have no expiration, allow cash or cashless exercise, and include beneficial ownership limits generally starting at 4.99% or 9.99%, adjustable up to 19.99% with at least 61 days’ prior notice.
Invivyd, Inc. (IVVD) filed an 8-K reporting Q3 2025 updates. The company furnished a press release announcing financial results for the quarter ended September 30, 2025 as Exhibit 99.1 under Item 2.02. This information is furnished and not deemed filed under Section 18 of the Exchange Act.
Invivyd also posted an updated corporate presentation on November 6, 2025, filed as Exhibit 99.2 and available on its website. The filing lists these materials and related exhibit identifiers.
Invivyd (IVVD) filed a routine update. On October 30, 2025, the company posted an investor presentation on its website and filed it as Exhibit 99.1 to a Form 8‑K under Item 8.01. The filing indicates the presentation is available at www.invivyd.com and is incorporated by reference in the report.
Invivyd, Inc. filed a current report to highlight a key regulatory milestone for its COVID-19 program. On October 6, 2025, the company issued a press release announcing U.S. IND clearance and alignment with the U.S. FDA on a pivotal clinical program for VYD2311, described as a vaccine-alternative antibody to prevent COVID. The press release was furnished as Exhibit 99.1 to this report.
Invivyd, Inc. appointed Paul B. Bolno, M.D. to its Board of Directors and Compensation Committee, effective September 22, 2025, filling a vacancy created by the same-day resignation of director Christine Akinc, who left without any disagreement on company matters. Dr. Bolno will receive an annual cash retainer of $40,000 for Board service and $5,000 for Compensation Committee service.
He was also granted a nonqualified option to acquire 100,000 shares of common stock, vesting over three years from September 22, 2025, and exercisable for 10 years at the closing market price on the grant date under the 2021 Equity Incentive Plan. Separately, Nasdaq notified Invivyd on September 22, 2025 that the company has regained compliance with the $1.00 minimum bid price requirement for continued listing on The Nasdaq Global Market, and the matter is now closed.
Invivyd, Inc. completed an offering of common stock and pre-funded warrants, selling pre-funded warrants convertible into 21,342,442 shares and common shares at a public price of $0.52 per share. The pre-funded warrants had a public price of $0.5199 each, reflecting the $0.0001 per share exercise price difference.
The underwriting agreement included a 30-day option to purchase up to 14,423,076 additional shares at the same price, and that option was exercised in full on August 21, 2025, bringing the combined issuance (initial shares plus exercised option) to 35,765,518 shares or the equivalent in pre-funded warrants. These transactions raise capital for the company but increase the number of outstanding shares available to the market, which affects existing shareholders through dilution.
Invivyd, Inc. filed a current report describing several disclosures made on August 14, 2025. The company issued a press release with its financial results for the quarter ended June 30, 2025 and recent business highlights, which is included as Exhibit 99.1.
Invivyd also released a separate press release titled “Invivyd Aligns with U.S. FDA on Rapid Pathway to Full Approval (BLA) of Vaccine Alternative Monoclonal Antibody VYD2311 to Protect American Adults and Adolescents from COVID-19,” filed as Exhibit 99.2. In addition, the company posted an updated corporate presentation on its website, furnished as Exhibit 99.3.
Invivyd, Inc. (Nasdaq: IVVD) filed an 8-K to disclose that, on July 2, 2025, it issued a press release announcing the formation of the SPEAR (Spike Protein Elimination and Recovery) Study Group. The collaboration brings Invivyd together with leading researchers to evaluate the effects of the company’s monoclonal antibody therapy on two patient populations: 1) individuals suffering from Long COVID and 2) those experiencing COVID-19 post-vaccination syndrome.
The filing contains no financial results, trial data, or guidance. Instead, it simply furnishes the press release as Exhibit 99.1 under Item 8.01 (Other Events) and lists customary exhibit and signature information.
Invivyd (Nasdaq: IVVD) filed an 8-K under Item 8.01 to furnish a press release dated 26 June 2025.
The release reports positive full Phase 1/2 clinical data for VYD2311, a next-generation COVID-19 monoclonal antibody being pursued for both non-vaccine prophylaxis and treatment of active infection.
The document attaches the press release as Exhibit 99.1; no financial statements, guidance changes, or other material corporate actions were disclosed.