CHARLOTTE, N.C., Aug. 6, 2013 (GLOBE NEWSWIRE) -- Chelsea Therapeutics International, Ltd. (Nasdaq:CHTP) today reported financial results for the second quarter ended June 30, 2013.
"Chelsea continues to diligently manage its financial resources, which are projected to fund operating expenses into the third quarter of 2014, as we work to finalize our NDA submission for NORTHERA™ (droxidopa) in the treatment of symptomatic Neurogenic Orthostatic Hypotension (NOH)," said Joseph G. Oliveto, Interim CEO of Chelsea. "We anticipate that this effort will be completed in August, at which point a new PDUFA date, expected in the first quarter of 2014, will be set by the Agency."
- In early July 2013, Chelsea resubmitted its New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking approval to market Northera for the treatment of symptomatic NOH. On July 29, Chelsea reported that the U.S. Food and Drug Administration (FDA) identified certain technical difficulties with the resubmitted New Drug Application (NDA). The Company expects to submit the necessary response in August 2013, at which point a new six month Prescription Drug User Fee Act (PDUFA) review clock is expected to begin.
- In June 2013, Chelsea was added to the Russell 3000® and Russell 2000® Indexes when the Russell Investment Group reconstituted its family of U.S. indexes.