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BCS

Current Report · Items 8.01, 9.01 · 8-K

Invivyd, Inc.

IVVDNASDAQEQUITYCurrent

Other Events

Item 8.01 Other Events. On September 29, 2026, Invivyd, Inc. (the “Company”) issued a press release entitled “Invivyd Announces Positive Topline Results from LIBERTY Phase 3 Study Demonstrating VYD2311 Safety and Tolerability Superior to mRNA-based COVID-19 Vaccine;…

Filed Sep 29, 2026Accepted Sep 29, 2026, 7:26 AM EDTCIK 1832038Accession 0001193125-26-406007
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Company context

Invivyd, Inc. (Nasdaq: IVVD) is a biopharmaceutical company devoted to delivering protection from serious viral infectious diseases, beginning with SARS-CoV-2. Invivyd deploys a proprietary integrated technology platform unique in the industry designed to assess, monitor, develop, and adapt to create best in class antibodies. In March 2024, Invivyd received emergency use authorization (EUA) from the U.S. FDA for a monoclonal antibody (mAb) in its pipeline of innovative antibody candidates. Visit https://invivyd.com/ to learn more.

Current securities

Recent company filings

  1. 4 filingSep 2, 2026
  2. 3 filingSep 2, 2026
  3. 4 filingSep 1, 2026
  4. Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements · Other EventsSep 1, 2026
  5. 4 filingAug 18, 2026

Registered securities in this filing

Invivyd, Inc. · 8-K · Filed 2026-09-29

As filed in this accession. Current/historical status below comes from the governed listing record; the cover itself remains exact to this filing.

Common stock, par value $0.0001 per share

Symbol
IVVD
Exchange
NASDAQ
Classification
COMMON
Status
Current
Filing context

Context: C_9e3e1896-1c86-4abf-a222-eb0e1c0c8967

Dimensions: Not supplied

Accession 000119312526406007 · 1 registered-security cover member

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Disclosure sections

Items 8.01, 9.01

Select an item to read the extracted section. The as-filed document remains the primary evidence.

Item 8.01Item 8.01 - Other Events
Item 8.01 Other Events. On September 29, 2026, Invivyd, Inc. (the “Company”) issued a press release entitled “Invivyd Announces Positive Topline Results from LIBERTY Phase 3 Study Demonstrating VYD2311 Safety and Tolerability Superior to mRNA-based COVID-19 Vaccine; Announces Regulatory Submission Plans for VYD2311.” A copy of the press release is filed as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated by reference into this Item 8.01. On September 29, 2026, the Company posted an updated corporate presentation on its website at www.invivyd.com. A copy of the presentation is filed as Exhibit 99.2 to this Current Report on Form 8-K and is incorporated by reference into this Item 8.01.
Filed exhibits (2)
EX-99.1 (by filename) ivvd-ex99_1.htm

Exhibit 99.1 Invivyd Announces Positive Topline Results from LIBERTY Phase 3 Study Demonstrating VYD2311 Safety and Tolerability Superior to mRNA-based COVID-19 Vaccine; Announces Regulatory Submission Plans for VYD2311 • VYD2311 met all primary and secondary endpoints comparing VYD2311 to an mRNA-based COVID-19 vaccine, demonstrating VYD2311 safety and tolerability that is clinically and statistically superior to the safety and tolerability of an mRNA-based COVID-19 vaccine • VYD2311 combined with an mRNA-based COVID-19 vaccine demonstrated no interference with vaccine-induced neutralizing titers, and instead added substantially to vaccine-induced neutralizing titers • VYD2311 observed profile in LIBERTY indicates high measured antiviral activity supporting the target profile for VYD2311 under study in the DECLARATION pivotal clinical study • Invivyd plans for DECLARATION and LIBERTY clinical studies to be the basis of a planned Biologics License Application (BLA) submission for VYD2311 to the U.S. Food and Drug Administration via Accelerated Approval Program following a recent Type C meeting; DECLARATION topline data on safety and immunogenicity to support the submission are…

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EX-99.2 (by filename) ivvd-ex99_2.htm

Topline LIBERTY Data & VYD2311 Next Steps September 29, 2026 ©2026 Invivyd, Inc. Invivyd is a registered trademark of Invivyd, Inc. All trademarks in this presentation are the property of their respective owners. Exhibit 99.2 CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS This presentation contains forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. Statements in this presentation that are not statements of historical fact are forward-looking statements. Words such as “may,” “will,” “should,” “expect,” “plan,” “anticipate,” “seek,” “could,” “intend,” “target,” “aim,” “project,” “designed to,” “estimate,” “believe,” “predict,” “potential,” or “continue” or the negative of these terms or other similar expressions are intended to identify forward-looking statements, though not all forward-looking statements contain these identifying words. Forward-looking statements include statements concerning, among other things, the company’s vision; plans related to the company’s research and development activities, and the timing and potential results thereof, including with respect to the DECLARATION pivotal clinical trial; expecta…

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