Boston, MA 07/24/2013 (wallstreetpr) – Chelsea Therapeutics International Ltd. (NASDAQ:CHTP) announced that New Drug Application (NDA) resubmission seeking approval to market NORTHERA™ (droxidopa), got approval from U.S. Food and Drug Administration. NORTHERA, which is developed as an orally active synthetic precursor of the compound norepinephrine and is now in Phase III development for applications in the treatment of the disease related to symptomatic neurogenic orthostatic hypotension (NOH) in patients. The approval from U.S. Food and Drug Administration for NORTHERA was received after a year delay in bringing it to the market. It is expected that the FDA will say its decision after six months, the company also said there is increase in possibility of approval by FDA for Northera.
Joseph G. Oliveto Chief Executive of Chelsea Therapeutics International Ltd commented, “ our company now have two large randomized placebo-controlled clinical studies which has the successful result of Northera in statistically significant improvements, enhanced safety of Northera and consistent in the symptoms”. Recently Chelsea Therapeutics International Ltd. (NASDAQ:CHTP) was added to the Russell 2000 and Russell 3000 indexes when the U.S. indexes got reconstituted by Russell Investment Group, Russell’s U.S. indexes includes 4,000 largest U.S. stocks, Russell decides membership for its equity indexes primarily by market-capitalization rankings, style attributes and objective.
Shares of Therapeutics International Ltd. (NASDAQ:CHTP) decreased by 2.51% to close at $3.11 per share in the last trading session, with the opening price at $3.25 per share. The company had through the day moved in the intraday price range of $2.99 to $3.25 per share. With 67.09 million outstanding shares in the market, the stock has 38% institutional ownership of capital and $208.63 billion market capitalization. The 52 week low is at $0.73 and 52 week high is at $3.25 per share.
