Vanda Pharmaceuticals Inc, a biopharmaceutical company focused on the development and commercialization of products for the treatment of central nervous system disorders, released financial and operational results for the third quarter and 9 months ended September 30, 2012.
Key highlights include:
• The tasimelteon Non-24-Hour Disorder (Non-24) program continues toward the goal of a projected mid-2013 New Drug Application (NDA) filing with the US Food and Drug Administration (FDA).
• The SET and RESET Phase III efficacy studies for Non-24 are both fully enrolled. Vanda expects to report top-line results for the SET study by the end of 2012 and to report top-line results for the RESET study in the first quarter of 2013.
• The tasimelteon MAGELLAN Phase IIb/III efficacy study for Major Depressive Disorder (MDD) is fully enrolled and Vanda expects to report top-line results in the first quarter of 2013.
• Total revenues for the third quarter of 2012 were $8.3 million, compared to $8.0 million for the same period in 2011. Vanda recorded a net loss of $5.3 million for the third quarter of 2012, compared to a net loss of $3.1 million for the third quarter of 2011.