Vanda Pharmaceuticals Inc. (VNDA), Friday announced that the U.S. Food and Drug Administration is conducting an expedited re-review of the partial clinical hold that currently restricts long-term clinical studies of tradipitant in motion sickness.
The original target completion date of November 26, 2025 has been extended to December 5, 2025 at the agency's request to accommodate recent personnel and leadership transitions within the Center for Drug Evaluation and Research.
However, the PDUFA target action date of December 30, 2025 for the New Drug Application remains unchanged. Also, FDA has formally commenced labeling discussions with the company, and has issued comments on the proposed labeling.
In the pre-market hours, VNDA is trading at $5.25, down 0.94 percent on the Nasdaq.
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