FDA snubs Vanda Pharma's NDA for tradipitant in gastroparesis

Vanda Pharmaceuticals’ (Nasdaq: VNDA) shares were down more than 10% at $4.45 pre-market today, as the company provided an unfavorable update on its tradipitant development program.

The company said that the US Food and Drug Administration (FDA) yesterday declined to approve Vanda's New Drug Application (NDA) of tradipitant for the treatment of symptoms in gastroparesis, issuing Vanda with a Complete Response Letter (CRL). Gastroparesis is a serious condition that is characterized by delayed gastric emptying and associated with severe nausea, vomiting, difficulty finishing a normal meal and other symptoms that have a significant impact in people's everyday living and functioning. Gastroparesis is often associated with diabetes but is also found in nondiabetic individuals and has recently been associated with the class of GLP1 inhibitors, Vanda noted.

Jefferies analysts suggested in a recent note that a delay to the FDA review of tradipitant, or a CRL, "could be possible" given that correspondences with the FDA "have been quiet."