ARS Pharmaceuticals Shares Sink to New Lows on FDA Neffy Setback

By Colin Kellaher

ARS Pharmaceuticals shares lost more than half of their value and hit an all-time low on Wednesday after the U.S. Food and Drug Administration turned away its proposed epinephrine nasal spray "neffy" and called on the company to conduct another study.

Shares of the San Diego company were recently changing hands at $3.04, down 54%, after touching an all-time low of $2.55 early in the session.

Following a positive vote by one of its advisory committees in May, the FDA had been expected to approve neffy as the first needle-free epinephrine product for severe allergic reactions.

However, ARS late Tuesday said the agency issued a so-called complete response letter, indicating that it wouldn't approve the application in its current form and calling on ARS to complete a repeat-dose study prior to approval.

ARS said had previously reached alignment with the FDA on conducting the repeat-dose study after a green light for neffy.

ARS said it plans to dispute the FDA's ruling. The company said it also plans to complete the new trial as quickly as possible, and that it aims to resubmit neffy to the FDA in the first half of 2024, setting the stage for a decision in the second half of the year.

Write to Colin Kellaher at [e-mail]

(END) Dow Jones Newswires

September 20, 2023 10:05 ET (14:05 GMT)

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