Late Friday afternoon regulators at the FDA approved Acorda's multiple sclerosis drug Ampyra based on data demonstrating that patients taking dalfampridine were able to walk faster than a control group. And this is the first time the FDA has approved a therapy for improving walking speeds.
"Trouble with walking is one of the most debilitating problems people with MS face," said Russell Katz, director of the Division of Neurology Products in the FDA's Center for Drug Evaluation and Research.
Acorda had the solid backing of the FDA's experts for the drug. The advisory committee voted 12 to 1 in favor of a marketing approval. And investors were betting on an approval. Acorda's shares jumped close to 10 percent on Friday, ahead of the announcement.
But what many speculators are looking for is an acquisition. Biogen has licensed the ex-U.S. rights to the drug. And BNET's Trista Morrison is quoting Raghuram Selvaraju, an analyst with Hapoalim Securities, who believes that the approval sets the stage for an acquisition by one of the leading players in the field. Biogen, Merck Serono, Novartis, Sanofi and Teva were all mentioned as possible contenders.
- here's the Wall Street Journal report
- check out the AFP story
- and here's the BNET piece