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Vanda Pharmaceuticals Stock Jumps on Positive Sleep Disorder Drug Trial Results
Summary
The biopharmaceutical company's stock jumped in after-hours trading after it announced its drug Hetlioz met its primary endpoint in a Phase III trial for delayed sleep-wake phase disorder.
Shares of Vanda Pharmaceuticals (NASDAQ: VNDA) surged in after-hours trading on Tuesday following the company's announcement of positive results from a Phase III clinical trial for its drug, Hetlioz.
Trial Meets Primary Endpoint
Vanda reported that its study of Hetlioz for the treatment of delayed sleep-wake phase disorder (DSWPD) successfully met its primary endpoint. According to a company statement, the drug was shown to induce sleep significantly earlier than a placebo.
Following the positive data, Vanda plans to engage with the U.S. Food and Drug Administration (FDA) to discuss the results. The company intends to submit a supplemental new drug application (sNDA) to expand the approved uses of Hetlioz to include DSWPD.
AdMarket Impact and Outlook
Investors reacted favorably to the news, sending Vanda's stock up 12.0% to $5.63 in after-hours trading. The potential approval for this new indication is a significant development for the company.
If the sNDA is approved, Hetlioz would become the first FDA-approved medicine specifically for the treatment of DSWPD. The drug is already approved by the FDA for other conditions, which can sometimes provide a clearer regulatory pathway for supplemental applications.
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