Acorda resubmits MS drug early, shares jump

Acorda saw its shares rebound Thursday on the news that the company has resubmitted its experimental multiple sclerosis drug fampridine to the FDA ahead of schedule. Last month, the FDA refused to review the drugmaker's application [1], asking the company to reformat its submission and provide more information on the drug. The drugmaker's stock plunged 23 percent on the annoucement  that the FDA had requested the company reformat its submission and provide more information on the drug on March 31. Acorda said it would address the FDA's requests "expeditiously" and it did just that.

Analysts say that given the rapid turnaround, the FDA's requests were likely minor. Still, shareholders rewarded the company's expediency with a 24 percent increase in its share price to a high of $22.80. "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 told Reuters.

Analysts expect the FDA to accept the submission by late June and make a decision in February 2010, Reuters reports. Acorda is shopping for a European partner for the drug, but analysts say fampridine makes the drugmaker a prime buyout target. Fampridine is designed to improve walking ability in MS patients. If granted marketing approval, fampridine would be the first MS drug to reverse a symptom of the disease. "Acorda is at the top of the list of small biotechs to be acquired. But that is more likely after approval," RBC's Yee tells Reuters.

- get more [2] from Reuters

Related Articles:
FDA refuses to review Acorda MS drug [1]
Acorda reports positive results on MS drug [3]
Acorda announces added trial [4] (2006)
Acorda shares soar on late-stage MS data [5] (2006)