Invivyd, Inc. 8-K
Accession 0001193125-25-329488
Filed
Dec 22, 7:00 PM ET
Accepted
Dec 23, 7:08 AM ET
Size
319.3 KB
Accession
0001193125-25-329488
Research Summary
AI-generated summary of this filing
Invivyd Announces Fast Track Designation for COVID Antibody VYD2311
What Happened
Invivyd, Inc. (IVVD) announced on December 23, 2025 (filed on Form 8‑K, Item 8.01) that it earned Fast Track designation for VYD2311, which the company describes as a vaccine‑alternative antibody to prevent COVID. The company attached the press release as Exhibit 99.1 to the filing.
Key Details
- Date of announcement: December 23, 2025 (8‑K Item 8.01).
- Program/product: VYD2311 — described as a vaccine‑alternative antibody to prevent COVID.
- Disclosure: Press release filed as Exhibit 99.1 to the Form 8‑K.
- Filing items: 8.01 (Other Events); exhibits listed under 9.01.
Why It Matters
A Fast Track designation is a regulatory pathway intended to facilitate development and expedite review of therapies that address unmet medical needs for serious conditions. For investors, this designation can accelerate regulatory interactions and potentially shorten development timelines for VYD2311, which may affect the program’s clinical and commercial prospects. Investors should watch for subsequent clinical data releases and regulatory updates from the company.
Documents
- 8-Kivvd-20251223.htmPrimary
8-K
- EX-99.1ivvd-ex99_1.htm
EX-99.1
- GRAPHICimg59752938_0.jpg
GRAPHIC
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Issuer
Invivyd, Inc.
CIK 0001832038
Related Parties
1- filerCIK 0001832038
Filing Metadata
- Form type
- 8-K
- Filed
- Dec 22, 7:00 PM ET
- Accepted
- Dec 23, 7:08 AM ET
- Size
- 319.3 KB