Shares of the San Diego company were recently changing hands at $3.04, down 54%, after touching an all-time low of $2.55 early in the session. Following a positive vote by one of its advisory committees in May, the FDA had been expected to approve neffy as the first needle-free epinephrine product for severe allergic reactions. However, ARS late Tuesday said the agency issued a so-called complete response letter, indicating that it wouldn't approve the application in its current form and calling on ARS to complete a repeat-dose study prior to approval. ARS said had previously reached alignment with the FDA on conducting the repeat-dose study after a green light for neffy. Write to Colin Kellaher at colin.kellaher@wsj.com(END) Dow Jones NewswiresSeptember 20, 2023 10:05 ET (14:05 GMT)Copyright (c) 2023 Dow Jones & Company, Inc.

Source: Wall Street Journal September 20, 2023 14:13 UTC