Investing.com -- Shares in ARS Pharmaceuticals (NASDAQ:SPRY) tumbled by more than 55% in early U.S. trading on Wednesday after the Food and Drug Administration requested additional testing be performed on the company's nasal spray for allergic reactions.
The biotech group said late Tuesday that the FDA had issued a letter rejecting and asking for additional study of neffy -- an epinephrine nasal spray -- before it could sign off on the drug, which is being touted as the first needle-free emergency treatment of allergic reactions.
The move stood in contrast to a May decision by the U.S. drug regulator's independent panel of experts to back neffy, which is broadly viewed as an alternative to epinephrine self-injectors like EpiPen and Kaleo's Auvi-Q.
ARS Pharma's application had been based on trials in healthy patients and those having a rhinitis attack, although the tests did not include people suffering anaphylaxis -- a severe allergic reaction -- because of ethical concerns. According to an allergist cited by Reuters, regulators were worried about the lack of tests for anaphylaxis.
ARS said it was "very surprised" by the FDA's announcement, adding that it plans to submit a formal appeal request. It expects to turn in a new application in the first half of next year.
The firm noted that it expects to have anticipated cash, cash equivalents and short-term investments on hand of about $195 million at the time of the anticipated launch of neffy should it receive regulatory approval in the second half of 2024.
Reuters contributed to this report.