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News Breaks
March 25, 2013
06:57 EDTVNDAVanda reports successful completion of pre-NDA meeting with FDA on tasimelteon
Vanda Pharmaceuticals announced that the company held a pre-NDA meeting with the Division of Neurology Products of the FDA to discuss the regulatory path for filing a New Drug Application, or NDA, for tasimelteon, a circadian regulator, for the treatment of Non-24-Hour Disorder. Non-24 is a serious, rare circadian rhythm disorder that affects a majority of totally blind individuals. Currently there is no FDA approved treatment for Non-24. At the pre-NDA meeting, the FDA confirmed that the efficacy and safety data proposed by Vanda to be submitted in the tasimelteon NDA for Non-24 is adequate to support filing. The NDA supporting package that includes data from clinical pharmacology, pre-clinical pharmacology program, chemistry and manufacturing was also deemed adequate to support filing.
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August 14, 2014
11:46 EDTVNDAOptions with decreasing implied volatility
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August 13, 2014
10:33 EDTVNDAOptions with decreasing implied volatility
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August 12, 2014
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August 11, 2014
11:28 EDTVNDAOptions with decreasing implied volatility
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06:03 EDTVNDAVanda pullback a buying opportunity, says Piper Jaffray
Piper Jaffray recommends using the post-earnings pullback in shares of Vanda Pharmaceuticals as a buying opportunity. Piper says Hetlioz is launching well and that it sees no reason to back off its bullish stance or $25 price target. The firm reiterates an Overweight rating on the name.

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