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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.
News For VNDA From The Last 14 Days
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October 29, 2014
09:01 EDTVNDAVanda 4M share Spot Secondary priced at $11.60
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October 28, 2014
16:02 EDTVNDAVanda files to sell common stock, no amount given
Jefferies LLC and Piper Jaffray & Co. are acting as the joint book-running managers for the offering.
08:05 EDTVNDAPressure on Vanda unwarranted, says JMP Securities
After Vanda reported stronger than expected Q3 results, JMP Securities thinks the pressure on the stock is disconnected from the company's strong Helioz launch. The firm keeps a $30 price target and Outperform rating on the shares.
October 27, 2014
09:14 EDTVNDAOn The Fly: Pre-market Movers
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07:18 EDTVNDAVanda reports Q3 total operating expenses $16.2M compared to $14.1M a year ago
07:17 EDTVNDAVanda cuts FY14 operating expenses to $105M-$110M from $110M-$120M
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07:17 EDTVNDAVanda reports Q3 Hetlioz US sales grew to $5.2M
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07:16 EDTVNDAVanda reports Q3 EPS (4c), consensus (39c)
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