FDA lifts partial clinical hold on Vanda's tradipitant for motion sickness

Vanda Pharmaceuticals Inc.

FDA lifted partial clinical hold on protocol VP-VLY-686-3403, removing the 90-dose cap on tradipitant studies.
Lift followed Vanda's formal dispute resolution and expedited re-review under October 2025 collaborative framework.
FDA agreed motion sickness is acute, event-driven; no additional dog toxicity study required.
NDA for tradipitant to prevent vomiting due to motion remains under review; PDUFA date December 30, 2025.
CEO Mihael Polymeropoulos thanked FDA for swift scientific review and constructive dialogue.

This headline and bullets were generated automatically by deepseek-v4-flash:cloud@v2 from the public filing. Read the source on SEC.gov before relying on any specific claim. Not investment advice. See methodology for how this pipeline works.