Ahead of the Bell: Chelsea Therapeutics advances
Shares of Chelsea Therapeutics International Ltd. soared Friday in premarket trading after a panel of Food and Drug Administration advisors backed its drug Northera, which is designed to help prevent falling in patients with conditions like Parkinson's disease.
The Charlotte, N.C., company said Thursday that the FDA's Cardiovascular and Renal Drugs Advisory Committee voted 7 to 4 to recommend the drug's approval. The FDA is expected to make its decision by March 28. It is not required to follow the advice of its panels, but it often does.
Northera, or droxidopa, is designed to treat neurogenic orthostatic hypotension, which is a drop in blood pressure on standing. It's a common symptom of Parkinson's disease, and can make patients get dizzy and fall.
Northera has orphan drug status, which the FDA gives to drugs for rare illnesses or diseases for which there is no treatment. It comes with marketing exclusivity if the product is approved.
Shares climbed $1.94, or 81 percent, to $4.35 before markets opened.