By Adriano Marchese
Invivyd's stock fell sharply in pre-market trading Monday after U.S. regulators denied a request for its drug Pemgarda to be used in treating Covid-19 in more cases.
Shares traded 37% lower ahead of the morning bell at $1.12.
The commercial-stage biopharmaceutical company said its request to expand the existing emergency use authorization of the drug, also called pemivibart, to treat mild-to-moderate Covid-19 in more people was declined by the Food and Drug Administration.
Invivyd wanted to expand its use to adults and adolescents who have moderate-to-severe immune compromise due to certain medical conditions such as cancer and organ transplant, where other alternative Covid-19 treatment options weren't possible.
The recent denial by the FDA doesn't affect its existing emergency use authorization for pre-exposure prophylaxis of Covid-19 in certain immunocompromised patients, which still remains in effect, Invivyd said.
Write to Adriano Marchese at adriano.marchese@wsj.com
(END) Dow Jones Newswires
February 24, 2025 07:48 ET (12:48 GMT)
Copyright (c) 2025 Dow Jones & Company, Inc.
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