Invivyd Stock Surges on Positive PEMGARDA™ Data and Regulatory Updates

Invivyd, Inc. (NASDAQ: IVVD), a biopharmaceutical company focused on developing antibody-based solutions for infectious diseases, has seen its stock price surge recently on the back of positive data and regulatory updates for its PEMGARDA™ (pemivibart) monoclonal antibody. PEMGARDA is an investigational, half-life extended monoclonal antibody (mAb) designed for the prevention of COVID-19 in adults and adolescents.

On January 10, 2025, Invivyd announced that new in vitro neutralization data showed continued neutralizing activity of PEMGARDA against the dominant SARS-CoV-2 variant XEC. As anticipated based on the structural biology of pemivibart and VYD2311, the data were largely consistent with those previously reported for KP.3.1.1. The Centers for Disease Control (CDC) estimates that XEC and KP.3.1.1 accounted for an aggregate 69% of U.S. circulating variants of SARS-CoV-2 for the two weeks ended December 21, 2024. Invivyd generated these new data as part of its ongoing industrial virology effort, which leverages a consistent, high-quality, independent, third-party pseudoviral system that routinely tests authentic Invivyd-produced pemivibart and is supported by extensive structure-based and proprietary analytics.

Invivyd has demonstrated positive PEMGARDA neutralization activity against over 75% of currently circulating U.S. variants, and all prior variants, tested to date. Further, the company estimates that every clinical variant reported in the CDC COVID Tracker since the Omicron BA.1 lineage has been susceptible to pemivibart even if untested due to the consistent structural integrity of the pemivibart epitope. Therefore, Invivyd does not anticipate any meaningful change to pemivibart neutralization activity, aside from expected normal quantitative variation in assay output, for the foreseeable future if the epitope pemivibart targets remains structurally intact, as it has since Omicron BA.1.



In addition to the positive data, Invivyd has received regulatory updates and fact sheet revisions from the U.S. Food and Drug Administration (FDA). For instance, the FDA updated the PEMGARDA™ EUA Fact Sheet with accurate SARS-CoV-2 variant susceptibility and PEMGARDA activity data on October 1, 2024. These regulatory updates and positive data have contributed to the stock's recent price movement.



Invivyd's stock price has been volatile in recent months, but the company's positive data and regulatory updates have contributed to its recent surge. As the COVID-19 pandemic continues to evolve, Invivyd's focus on developing effective antibody-based solutions for infectious diseases positions it well to capitalize on market opportunities. Investors should closely monitor the company's progress and the broader market landscape to make informed decisions about their portfolios.