As of December 31, 2007, Vanda's cash, cash equivalents, and marketable securities totaled approximately $93.2 million. As of December 31, 2007, the company had a total of approximately 26.6 million shares of common stock outstanding.
"I am extremely pleased with the successful submission and acceptance of the Fiapta(TM) NDA filing in 2007. This important achievement would not have been possible without the commitment and dedication of the Vanda team," stated Mihael Polymeropoulos, M.D., President and CEO of Vanda. "I am looking forward to an exciting 2008 during which we expect the results from our VEC-162 Phase III chronic insomnia clinical trial and the PDUFA action for Fiapta(TM)."
On September 27, 2007 Vanda announced that it had submitted an NDA to the U.S. Food and Drug Administration (FDA) for Fiapta(TM), its investigational atypical antipsychotic for the treatment of schizophrenia. On November 27, 2007 the company announced that the FDA had accepted and filed the NDA. Under the Prescription Drug User Fee Act (PDUFA) of 1992, Vanda expects a PDUFA action on or about July 27, 2008.
Vanda has completed enrollment for its VEC-162 Phase III chronic
insomnia clinical trial. Vanda expects to report top-line results in June
2008. Vanda enrolled 324 patients in the trial, which is a randomized,
double-blind, placebo-controlled 35-day study, measuring sleep onset and
maintenance, as well as next-day performance.
-- Operating Expenses. Fourth quarter 2007 R&D expenses, primarily
consisting of salaries and related costs of R&D personnel, stock-based
compensation, and the costs of consultants, materials and s
|SOURCE Vanda Pharmaceuticals Inc.|
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