Chelsea Therapeutics International Ltd. (Nasdaq: CHTP) shares rose 24.4% Monday after the biotechnology company said it would file a new application for its hypotension treatment in the third quarter. The Charlotte-based company traded in 3.1 million shares, which sold for $4.95, or 97 cents better than Friday’s close.
The Company reaffirmed its NORTHERA™ (droxidopa) new drug application (NDA) filing strategy following correspondence with the U.S. Food and Drug Administration (FDA) regarding recent data from Northera Study 306A and protocol amendments to ongoing Northera Study 306B, comparing the rate of patient reported falls associated with symptomatic neurogenic orthostatic hypotension (NOH) in patients with Parkinson’s disease (PD) taking Northera versus placebo.
According to Chelsea President and CEO Dr. Simon Pedder, “We believe the remarkable safety and tolerability of Northera coupled with the robust clinical benefit demonstrated throughout our Phase III program provide a strong basis for the approval of Northera as a novel treatment for symptomatic neurogenic orthostatic hypotension.”
Pedder continued, “We continue to be appreciative of the guidance that the FDA has provided to Chelsea as we prepare to file this new NDA in the third quarter of 2011. Following the approval of Northera, we look forward to building on the clinical work currently underway in Study 306B and completing the necessary studies to allow for a post-marketing expansion of the label including a claim that Northera reduces falls in neurogenic orthostatic hypotension from Parkinson’s Disease.”
Chelsea is a biopharmaceutical development company that acquires and develops innovative products for the treatment of a variety of human diseases.