Apr 24, 2009

UPDATE 1-Acorda resubmits MS drug filing, shares up

* Resubmits NDA for Fampridine-SR

* Shares rise as much as 24 pct (Recasts; adds analysts' comments, byline; updates stock movement)

By Esha Dey

BANGALORE, April 23 (Reuters) - Shares of Acorda Therapeutics Inc (ACOR.O) rose 24 percent after it resubmitted its experimental multiple sclerosis drug for marketing approval, sooner than expected.

Last month, the Food and Drug Administration refused to accept the filing of the company's multiple sclerosis treatment, Fampridine-SR, citing certain "format issues" and requested additional supporting information.

On March 31, Acorda shares fell about 23 percent on news of the delay.

Although analysts are still unsure of the specific nature of the data requested, they said resubmission of the filing in less than a month's time implies that the issues raised in the FDA's refuse-to-file letter were minor.

"While investors held wide ranging estimates for the length of delay that Fampridine faced in gaining approval, Fampridine's resubmission comes significantly ahead of even the more optimistic expectations," Cowen and Co analyst Phil Nadeau said.

Analysts now expect the FDA to accept the resubmitted filing by late June, with an action date on the drug in February 2010.

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