On September 19, 2023, ARS announced it received from the Food and Drug Administration (FDA) a Complete Response Letter (CRL) concerning ARS’ “neffy.” “Neffy” is a nasally administered epinephrine dose used in cases of severe allergic reactions. The CRL indicated ARS must complete additional studies on “neffy” before the FDA can consider further the drug’s approval. In particular, the FDA indicated ARS must provide data concerning repeated doses of nasal epinephrine in individuals experiencing allergic reactions.
Following this news, ARS’ stock price fell by $4.52 per share, or approximately 61% to close at $2.92 per share.
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