Pre-market Shock: ARS Pharmaceuticals Faces Setback
- September 20th, 2023
- 660 views
Shares of ARS Pharmaceuticals, Inc. (Nasdaq: SPRY) plunged over 40% following the announcement that the U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) regarding its New Drug Application (NDA) for neffy (epinephrine nasal spray) in the treatment of Allergic Reactions (Type I), including anaphylaxis for adults and children weighing 30 kg or more. The company plans to submit a Formal Dispute Resolution Request (FDRR) to appeal the FDA's decision.
The FDA's request for a pharmacokinetic/pharmacodynamic study assessing repeat doses of neffy aims to support approval, despite the prior recommendation of the FDA Advisory Committee (PADAC) in May 2023 to approve neffy without the need for additional studies to demonstrate its efficacy or safety, also indicating a favorable benefit-risk profile for ARS Pharmaceuticals' intranasal epinephrine product.
$SPRY was trading at $3.51 in pre-market, reflecting a substantial decline of $3.09 (-46.85%)
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