(RTTNews) – Vanda Pharmaceuticals Inc. (VNDA), Friday announced that the FDA has requested, and the company has agreed to, a brief extension of the expedited re-review of the partial clinical hold on long-term studies of tradipitant in motion sickness, moving the target completion date from November 26, 2025, to December 5, 2025.
Separately, the FDA has issued labelling comments and formal discussions have begun for the New Drug Application (NDA) of tradipitant for the prevention of vomiting induced by motion.
The PDUFA target action date remains December 30, 2025.
Tradipitant is a neurokinin-1 receptor antagonist licensed from Eli Lilly and is in development for multiple indications, including gastroparesis, motion sickness, and nausea and vomiting associated with GLP-1 receptor agonists.
Vanda recently reported positive Phase 2 results showing tradipitant reduced GLP-1 agonist- induced nausea and vomiting, positioning it as a potential adjunct therapy in the fast-growing GLP-1 market.
VNDA closed Friday’s trading session at $5.36, up 1.13%. Over the past 12 months the stock has traded between $3.81 to $5.70.
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