Invivyd Discloses General Alignment With U.S. FDA On Repeatable, Expedient Emergency Use Authorization Pathway For Prevention And Treatment Of Symptomatic COVID-19, Based On Compact Clinical Programs To Establish Safety And Immunobridging
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Invivyd has disclosed a general alignment with the U.S. FDA on a repeatable and expedient emergency use authorization pathway for the prevention and treatment of symptomatic COVID-19. This pathway involves a master, registrational clinical trial protocol to streamline the evaluation of new monoclonal antibodies (mAbs). Invivyd plans to rapidly move towards a registrational clinical trial of VYD2311.
May 31, 2024 | 11:14 am
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Invivyd has aligned with the U.S. FDA on a streamlined emergency use authorization pathway for COVID-19 treatments, which could expedite the approval process for their monoclonal antibodies, including VYD2311.
The alignment with the FDA on a streamlined emergency use authorization pathway is likely to expedite the approval process for Invivyd's monoclonal antibodies, including VYD2311. This could lead to faster market entry and potential revenue generation, positively impacting the stock price in the short term.
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