Tradipitant

FDA decision deadlines include Vanda's tradipitant for gastroparesis (Sept 18), Zevra's arimoclomol for Niemann-Pick disease type C (Sept 21), Heron's extended-release needle for Zynrelef (Sept 23), Merck's Keytruda for pleural mesothelioma (Sept 25), and Bristol Myers Squibb's KarXT for schizophrenia (Sept 26). Sanofi and Regeneron await FDA verdict on Dupixent for COPD (Sept 27).

The FDA declined Vanda Pharmaceuticals' NDA for tradipitant to treat gastroparesis, citing insufficient evidence despite two placebo-controlled studies and patient data. Vanda criticizes the FDA's delay and decision, plans further submissions, and continues its expanded access program for patients.

Vanda Pharmaceuticals' stock rose 1.8% since April, lagging the S&P 500's 7% gain. Fanapt, approved for bipolar 1 disorder, faces market challenges due to lack of differentiation from generic antipsychotics. Upcoming catalysts include FDA decisions on tradipitant for gastroparesis and motion sickness, and a Phase I study for a CFTR inhibitor to treat cholera. Vanda's cash position is strong, but its product pipeline is weak, with potential revenue declines from Hetlioz and Fanapt due to generic competition. The company rejected takeover bids, emphasizing the need for strategic cash management.

Vanda Pharmaceuticals Inc. sued the FDA, claiming its drug application review process is unconstitutional due to an 'illegitimate decisionmaker' overseeing applications, specifically regarding the review of tradipitant by an acting director.