Invivyd (IVVD) has disclosed a new risk, in the Regulation category.
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Invivyd faces a significant business risk with its EUA for PEMGARDA, which hinges on the U.S. Department of Health and Human Services’ (HHS) ongoing evaluation of the public health emergency. Granted by the FDA under emergency circumstances, the EUA allows PEMGARDA’s use for specific high-risk populations in the absence of approved alternatives. However, should HHS decide the emergency use is no longer necessary, Invivyd would be compelled to discontinue marketing PEMGARDA in the U.S., which could severely disrupt its commercial operations and adversely affect its financial health. The inability to predict the EUA’s lifespan adds uncertainty to Invivyd’s market strategy and potential revenue streams.
Overall, Wall Street has a Moderate Buy consensus rating on IVVD stock based on 2 Buys.
To learn more about Invivyd’s risk factors, click here.
