By Colin Kellaher

 

ARS Pharmaceuticals shares surged in premarket trading Friday after the biopharmaceutical company won the backing of a U.S. Food and Drug Administration advisory committee for its proposed epinephrine nasal spray for the treatment of severe allergic reaction, including anaphylaxis.

Shares of the San Diego company, which closed Wednesday at $4.52, were recently up 68% premarket to $7.60. Trading in the stock was halted during Thursday's session.

ARS late Thursday said the FDA panel voted that available data support a favorable benefit-risk assessment for the spray, which the company plans to market as "neffy," for adults and children who weigh more than 66 pounds.

ARS said neffy, if approved by the FDA, would be the first needle-free epinephrine product for severe allergic reactions.

The FDA, which usually follows the advice of its advisory committees but it isn't bound by the recommendations, has set a mid-2023 target action date for neffy.

 

Write to Colin Kellaher at colin.kellaher@wsj.com

 

(END) Dow Jones Newswires

May 12, 2023 08:40 ET (12:40 GMT)

Copyright (c) 2023 Dow Jones & Company, Inc.
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