NEW YORK (AP) — Shares of Chelsea Therapeutics sank Friday as a Food and Drug Administration panel prepared to review its drug Northera expressed some skepticism about the blood pressure treatment. THE SPARK: A panel of FDA advisors is scheduled to discuss Northera next week. Based on materials posted to the FDA website, the agency appears to be skeptical about the drug. "The primary reason not to recommend approval is the lack of sufficient evidence of efficacy," the FDA's materials say, adding that only one clinical trial of the drug has been truly successful in the agency's view. "Evidence from two longer-term studies, 303 and 306, suggest no durability to any statistically significant endpoint." One reviewer said the FDA should ask Chelsea Therapeutics for more information because its research doesn't provide enough evidence Northera works. The FDA is not required to follow their advice of its advisory panelists, but it often does so. THE BIG PICTURE: Northera, or droxidopa, is designed to treat neurogenic orthostatic hypotension, or a drop in blood pressure upon standing. The condition is common in patients with Parkinson's disease, which is the second-most common neurodegenerative disorder in the U.S. Chelsea Therapeutics has no approved drugs, and Northera is its most advanced drug candidate. The company has been trying to gain marketing approval for Northera since 2011. THE ANALYSIS: Wedbush analyst Liana Moussatos said the FDA often takes a skeptical approach ahead of panel meetings. She expects the meeting to go well for Chelsea Therapeutics , but said she thinks the drug has a 50-50 shot at approval. Moussatos noted that the documents posted before the company's last review, in early 2012, were also skeptical. While the panel voted in favor of approval, the FDA took a different tack and asked Chelsea Therapeutics for more information. Moussatos has an "Outperform" rating on the stock with a price target of $8 per share. SHARE ACTION: Chelsea Therapeutics shares lost $1.03 , or 29.2 percent, to $2.50 in afternoon trading. The stock's value has climbed since February, after the company convinced the FDA to change its opinion on a study of Northera. The shares closed at $3.53 Thursday after closing at 77 cents on Feb. 19 .
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