Shares of ARS Pharmaceuticals (NASDAQ: SPRY) were down more than 57% as of 11:30 a.m. ET on Wednesday after the company announced the Food and Drug Administration (FDA) had rejected its lead therapy. The stock is down more than 65% this year and reached a 52-week low on Wednesday of $2.55.

ARS is a clinical-stage biotech company that focuses on therapies to treat Type 1 allergic reactions from food, medications, and insect bites. The company said Tuesday after the markets closed that the FDA issued a Complete Response Letter (CRL) regarding its New Drug Application (NDA) for its epinephrine nasal spray Neffy. In the CRL, the FDA requested completion of a study assessing repeat doses of Neffy before it would approve the therapy. 

The drug would be an alternative to epinephrine injectable therapies such as EpiPen and would be used for Type 1 allergic reactions that could lead to life-threatening anaphylactic shock. ARS said that it was initially told last month by the FDA that it would be allowed to complete the dosing study once the drug was on the market. 

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Source Fool.com