Conflicting evidence from late-stage clinical work has knocked Chelsea Therapeutics over once again. The FDA has sent its lead product Northera back for more work, saying the product needs additional supporting study and to demonstrate durability of treatment effect in patients with dangerously low blood pressure.
Shares in the North Carolina company fell sharply on the news, down 26% to $2.73 in early trading today. Executives said an ongoing 10-week trial of Parkinson’s disease patients could be amended to meet the FDA’s request for up to three months of data, but the decision will delay approval of the agent until 2013. With only enough cash to last until early 2013, Chelsea is in a tight spot.