Vanda Pharmaceuticals Inc. has reached a collaborative agreement with the U.S. Food and Drug Administration to resolve several ongoing disputes involving its drugs Hetlioz and tradipitant. As part of the agreement, Vanda will dismiss lawsuits related to the FDA's clinical hold on tradipitant for motion sickness and regarding the dissemination of information about Hetlioz for jet lag disorder. The FDA will expedite its review of the clinical hold on tradipitant, aiming for a decision by November 26, 2025, and will continue reviewing the new drug application for this indication, with a target action date of December 30, 2025. Additionally, the FDA will conduct an expedited re-review of Vanda's supplemental application for Hetlioz in jet lag disorder by January 7, 2026, considering alternative indications focused on sleep-related symptoms. Both parties have also agreed to temporarily pause related administrative and legal proceedings during these reviews.