Vanda Pharmaceuticals (NASDAQ:VNDA) saw its shares rise more than 5% in premarket trading Monday following a favorable court ruling related to its sleep disorder treatment.
The company reported that a federal appeals court overturned the FDA’s rejection of its drug Hetlioz for treating jet lag disorder.
Previously, Vanda had petitioned the U.S. Court of Appeals for the D.C. Circuit after the FDA refused to hold a hearing on the drug’s approval. The agency had initially denied expanded approval in 2019, citing concerns over the unclear clinical significance of certain study measures.
Vanda stated that the court “set aside the FDA’s action” and now expects the agency to either approve Hetlioz or initiate a formal hearing regarding the matter.
Vanda Pharmaceuticals stock price
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