FDA Panel Gives Acorda's MS Drug Candidate Positive Review

Thu, 10/15/2009 - 5:02am
NEW YORK (AP) — Shares of Acorda Therapeutics Inc. skyrocketed in premarket trading Thursday after a Food and Drug Administration panel released a positive review of Acorda's drug candidate Fampridine-SR, increasing the chances the multiple sclerosis treatment will be approved for sale. By a 12 to 1 vote, the panel said studies show the drug improved walking in people with MS, Acorda said late Wednesday. In a 10 to 2 vote, the panel said the difference is clinically meaningful and that Fampridine-SR is safe for use. In premarket trading, Acorda shares climbed $8.73, or 52.2 percent, to $25.47. The shares closed at $16.74 on Tuesday. The FDA is scheduled to make a decision on Fampridine-SR by Oct. 22. The agency is not required to follow the recommendations of its advisory panels, but it often does so. The peripheral and central nervous system drug committee also voted that Acorda should be required to run additional studies on a lower dose of the drug. The Hawthorne, N.Y., company said it would be allowed to perform those studies after FDA approval, so they would not keep Fampridine-SR off the market. In a note to clients, Robert W. Baird analyst Christopher Raymond upgraded Acorda shares to "Outperform" from "Neutral," saying the panel vote went surprisingly well for Acorda. But he does not think Fampridine-SR will be approved in the next week. He said the FDA will delay approval until early 2010 as Acorda continues working on a risk evaluation plan. Raymond also thinks Wall Street is too optimistic about sales of Fampridine-SR. But he raised his price target on shares of the Hawthorne, N.Y., company to $28 from $24. Acorda stock has traded between $14.42 and $29.27 in the last year.

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