Vanda Up on EU News - Analyst Blog


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Vanda Pharmaceuticals Inc. 's ( VNDA ) shares are up 25.3% on the news that the European Medicines Agency (EMA) has accepted its Marketing Authorization Application (MAA) for Hetlioz (tasimelteon). The company is looking to get Hetlioz approved for the treatment of non-24-hour sleep-wake disorder (Non-24) in the totally blind.

Hetlioz is already approved in the U.S. for Non-24 where it was launched this April. It is the first approved drug in this indication. Hetlioz has orphan drug designation in the U.S. and the EU for this indication.

We remind investors that Vanda has a license agreement with Bristol-Myers Squibb ( BMY ) to develop and commercialize Hetlioz. Under this agreement, Vanda will pay up to $25 million once cumulative Hetlioz sales reach $250 million as well as royalties on net sales of Hetlioz.

According to the company, nearly 130,000 people in the EU suffer from Non-24 sleeping disorder. This disorder mostly affects people who are totally blind.

Meanwhile, Vanda is working on strengthening its pipeline. Under an agreement with Eli Lilly and Company ( LLY ), the company acquired an exclusive worldwide license to develop and commercialize VLY-686. Currently, VLY-686 is in a phase II study in patients suffering from chronic pruritus as a result of atopic dermatitis.

Additionally, Vanda has plans to initiate a pediatric study on Hetlioz for Non-24. We expect investor focus to remain on pipeline updates as well as Hetlioz's commercialization in the U.S.

Investors looking for well-positioned stocks in the biopharma sector may consider Gilead Sciences Inc. ( GILD ) carrying a Zacks Rank #1 (Strong Buy).

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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.

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