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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.
News For VNDA From The Last 14 Days
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March 4, 2015
18:37 EDTVNDAOn The Fly: After Hours Movers
UP AFTER EARNINGS: Roundy's (RNDY), up 12.7%... Pacific Ethanol (PEIX), up 11.5%... Miller Industries (MLR), 6.9%. ALSO HIGHER: Pharmacyclics (PCYC), up 2.8% after speculation of acquisition by Johnson & Johnson (JNJ). Johnson & Johnson is up marginally. DOWN AFTER EARNINGS: Semtech (SMTC), down 5.3%... Callon Petroleum (CPE), down 1.3%. ALSO LOWER: Vanda Pharmaceuticals (VNDA), down 7% following results from tradipitant Phase II study... Encana (ECA), down 4.2% after announcing C$1.25B bought deal offering... Apollo Commercial (ARI), down 2.9% after filing to sell 10M shares of common stock... Neustar (NSR), down 2.7% after making statement on LNPA vendor selection.
16:36 EDTVNDAVanda announces results from tradipitant Phase II study
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February 25, 2015
10:37 EDTVNDAOptions with decreasing implied volatility
Options with decreasing implied volatility: FUEL GREK NLNK HLSS SLXP LL VNDA AWAY DWA TRUE
February 24, 2015
10:08 EDTVNDAOptions with decreasing implied volatility
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February 23, 2015
10:17 EDTVNDAOptions with decreasing implied volatility
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