Invivyd, Inc. 8-K

What Happened

• Invivyd, Inc. (IVVD) filed a Current Report on Form 8‑K on July 6, 2026 to announce that it received a twelve‑months’ advanced notice of Emergency Use Authorization (EUA) termination for its product PEMGARDA® and provided an update on next steps with the U.S. Food and Drug Administration (FDA). The company issued a press release on July 6, 2026, which is filed as Exhibit 99.1 to the 8‑K.

Key Details

• Date of filing and press release: July 6, 2026.
• Action received: twelve months’ advanced notice of EUA termination for PEMGARDA®.
• Company action: issued a press release titled “Invivyd Announces Receipt of Twelve Months’ Advanced Notice of Emergency Use Authorization (EUA) Termination for PEMGARDA® and Provides an Update on Next Steps with the U.S. FDA” (Exhibit 99.1).
• The 8‑K reports the regulatory update under Item 8.01 (Other Events).

Why It Matters

• This is a material regulatory development for PEMGARDA’s U.S. authorization status. Investors should view this as an important update about the product’s regulatory timeline and monitor Invivyd’s forthcoming communications for details about FDA actions, timing, and any company plans to respond or pursue alternate regulatory pathways.