10:54 AM EDT, 04/03/2024 (MT Newswires) -- ARS Pharmaceuticals ( SPRY ) said Wednesday that it has submitted a response to the US Food and Drug Administration for its new drug application for neffy for the treatment of Type I allergic reactions including anaphylaxis.

The submission follows the receipt of a complete response letter from the regulator in September that requested the completion of a repeat dose pharmacokinetic/pharmacodynamic study of neffy under nasal allergen challenge conditions, and the completion of updated nitrosamine testing per the FDA's draft guidance issued in August last year.

"Based on multiple meetings with the FDA, we believe that we have responded fully and completely to the Agency's concerns and appreciate its insights along the way," said CEO Richard Lowenthal.

ARS said it expects an FDA review period of up to six months, with a decision anticipated to be Oct. 2.

Shares of ARS Pharmaceuticals ( SPRY ) rose past 3% in recent trading.

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