Vanda Pharmaceuticals(US:VNDA) The Motley Foolยท2024-09-19 21:20Core Viewpoint - Vanda Pharmaceuticals' stock experienced a significant decline following the FDA's rejection of its New Drug Application for tradipitant, impacting market enthusiasm for the company [1][2]. Group 1: FDA Rejection - The FDA declined to approve Vanda's New Drug Application for tradipitant, intended for treating gastroparesis, a stomach disorder [2]. - The FDA provided a Complete Response Letter (CRL) detailing its rejection, which Vanda criticized as being dismissive of the evidence presented and suggesting further studies that were inconsistent with expert advice [3]. Group 2: Company Response and Future Plans - Vanda plans to continue pursuing the commercialization of tradipitant despite the setback and will maintain support for an expanded-access program for gastroparesis patients [5]. - The company is also exploring tradipitant for additional indications, including motion sickness and atopic dermatitis, although only gastroparesis has been submitted for FDA approval [4].