Vanda Pharmaceuticals Inc, a biopharmaceutical company developing an oral compound designed to treat sleep and mood disorders, including circadian rhythm sleep disorders, released financial and operational results for the first quarter ended March 31, 2012. The company recorded a net loss of $8.0 million for the first quarter of 2012.
Vanda also reported operational milestones for the quarter, including:
• The tasimelteon Non-24-Hour Disorder (Non-24) program continues to advance toward the goal of a projected mid-2013 New Drug Application (NDA) filing with the US Food and Drug Administration (FDA). Vanda expects to complete the two Phase III efficacy studies, SET and RESET, by the end of 2012.
• Initial clinical data in the RESET study revealed potential of tasimelteon to reset the body clock in Non-24.
• The tasimelteon MAGELLAN Phase IIb/III efficacy study for Major Depressive Disorder (MDD) is ongoing and Vanda expects to report top-line results in the first half of 2013.
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