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Investing.com -- Shares of Vanda Pharmaceuticals (NASDAQ:VNDA) rose over 5% premarket trading Monday after the company announced a favorable court ruling regarding its sleep disorder drug.
The drugmaker said a federal appeals court overturned the U.S. Food and Drug Administration’s order that denied approval of its drug Hetlioz for the treatment of jet lag disorder.
Vanda had previously filed a petition for review with the U.S. Court of Appeals for the D.C. Circuit after the FDA declined to commence a hearing over approval for the drug.
The FDA had declined expanded approval for Hetlioz in 2019, citing unclear clinical significance of some measures used in a study.
According to the company, the court set aside the FDA’s action. Vanda anticipates the FDA will now either approve the drug or commence a hearing on the matter.
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