EX-99.1 2 ivvd-ex99_1.htm EX-99.1 EX-99.1 Exhibit 99.1 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 • U.S. Department of Health and Human Services (HHS) announced advanced Notice of Termination of the COVID-19 EUA declaration, effective June 29, 2027 • Consequently, Invivyd received from the U.S. Food and Drug Administration (FDA) Notice of Termination of the PEMGARDA EUA, to be effective on June 29, 2027, after a twelve-month transition period • Consistent with EUA transition processes, Invivyd is in dialogue with FDA about appropriate next steps for PEMGARDA • Invivyd intends to pursue every avenue to secure permanent, high quality medical protection from COVID infection for immune-compromised and other vulnerable Americans • PEMGARDA has demonstrated strong protection from COVID in a contemporary randomized clinical trial, has been growing in clinical use for more than two years, and is a critical non-vaccine option for vulnerable Americans that combines high antiviral activity and attractive safety demonstrated in clinical trials and po…
Open exhibit ↗Current Report · Items 8.01, 9.01 · 8-K
Invivyd, Inc.
IVVDNASDAQEQUITYCurrent
Other Events
Item 8.01 Other Events. On July 6, 2026, Invivyd, Inc. issued a press release entitled “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.” 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.
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.