Vanda Pharmaceuticals (VNDA) has disclosed a new risk, in the Regulation category.
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Vanda Pharmaceuticals faces significant uncertainty in obtaining FDA approval to commercialize key product candidates such as BysantiTM and imsidolimab, despite current NDA and BLA submissions. Prolonged review timelines, potential requests for additional studies, or outright rejection could delay revenues, increase costs, and erode any prospective competitive advantage.
Overall, Wall Street has a Strong Buy consensus rating on VNDA stock based on 3 Buys and 1 Hold.
To learn more about Vanda Pharmaceuticals’ risk factors, click here.