ARS Pharmaceuticals Shares Sink Premarket as FDA Rejects Neffy Spray

By Colin Kellaher

ARS Pharmaceuticals shares plunged in premarket trading Wednesday after the U.S. Food and Drug Administration rejected its proposed epinephrine nasal spray for the treatment of severe allergic reaction despite an earlier endorsement from an FDA advisory panel.

ARS, which plans to market the spray as "neffy," late Tuesday said the FDA issued a so-called complete response letter, indicating the agency won't approve the application in its current form, and called on the San Diego company to complete a repeat-dose study prior to approval.

ARS said it plans to appeal the decision, adding that it had reached alignment with the FDA last month on post-market requirements, including the repeat-dose study.

An FDA advisory panel in May recommended neffy approval based on current data, without recommending additional studies. The FDA usually follows the advice of its advisory committees, but it isn't bound by the recommendations.

ARS said it expects to resubmit its application in the first half of 2024, positioning it for potential approval in the second half of the year.

The company said it expects to have about $195 million in cash, equivalents and short-term investments at the time of the anticipated launch of neffy if approved in the second half of 2024.

Shares of ARS, which closed Tuesday at $6.60, were recently down 46% to $3.55 in premarket trading.

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

(END) Dow Jones Newswires

September 20, 2023 06:15 ET (10:15 GMT)

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