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Vanda issued a press release disclosing that “[o]n September 18, 2024, the U.S. Food and Drug Administration (FDA) declined to approve Vanda’s New Drug Application (NDA) of tradipitant for the treatment of symptoms in gastroparesis, providing Vanda with a Complete Response Letter (CRL).”
Following this news, Vanda’s stock price fell sharply during intraday trading on September 19, 2024.