Vanda Pharmaceuticals

FDA rejected Vanda Pharmaceuticals' tradipitant for gastroparesis, citing insufficient evidence. Vanda disputes the decision, arguing tradipitant's efficacy and safety, and plans to seek approval again while continuing its expanded access program.

Vanda Pharmaceuticals Inc. announced the FDA declined approval for tradipitant, aimed at treating gastroparesis symptoms, citing insufficient evidence. Despite supporting studies and patient advocacy, the FDA requested further research. Vanda plans to continue pursuing approval and supports an expanded access program for patients.

Vanda Pharmaceuticals Inc. announced the FDA declined approval for tradipitant to treat gastroparesis, citing insufficient evidence despite Vanda's studies. Vanda disputes the FDA's decision, plans further submissions, and continues its expanded access program for patients.

FDA issued a Complete Response Letter to Vanda Pharmaceuticals regarding the NDA for tradipitant for gastroparesis treatment, requesting additional studies. Despite statistically significant improvements in nausea and other symptoms observed in trials, the application could not be approved in its current form.

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.