Chelsea to resubmit Northera NDA in 2Q13
Chelsea Therapeutics International Ltd. (NASDAQ:CHTP) said it will resubmit an NDA for Northera droxidopa to treat symptomatic neurogenic orthostatic hypotension (NOH) in late 2Q13 after FDA said data from the company's Phase III Study 306B trial may be sufficient as the basis of the resubmission. The news sent shares of Chelsea up $1.18 (154%) to $1.94 on Wednesday. The company is still well below its close of $3.67 on March 28, 2012, before FDA issued a complete response letter for Northera requesting data from an additional trial to show durability of effect over a 2-3 month period (see BioCentury Extra, March 28, 2012).
In July, Chelsea had said that the agency recommended the company conduct an additional trial of Northera besides Study 306B. However, according to the company, FDA stated that existing data from the trial now have "the potential to serve as the basis" for Northera's resubmission. ...