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Shares of Invivyd (NASDAQ:IVVD) closed 42% higher Friday after the biotech company announced it had received FDA emergency use authorization, or EUA, for its COVID-19 prophylactic drug Pemgarda and released Phase 3 data about a similar product in development.
Invivyd stock was up 10% in post-market trading Friday evening.
Before market close on Friday, Invivyd said it had received FDA emergency use authorization for its therapy Pemgarda for the pre-exposure prevention of COVID-19 in patients who are moderately-to-severely immunocompromised.
Invivyd said Pemgarda, also known as pemivibart, is approved for patients aged 12 year and older who are immunocompromised due to medical conditions, treatments or medications and are unlikely to mount an adequate immune response to a COVID-19 vaccination.
The biotech company said that it expects the product to be available in the US “imminently.” It added that it finished 2023 with an estimated $200.6M in cash and equivalents.
Invivyd also released interim exploratory data from a Phase 3 study for its drug candidate VYD222, which it is also developing as a pre-exposure prophylaxis treatment for COVID-19.
