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Fampridine-SR Receives Priority FDA Review for Walking Drug
Acorda’s shares up sharply on news of FDA priority review for Fampridine-SR in multiple sclerosis
Shares in Acorda Therapeutics soared as much as 28 percent after the company announced that the FDA accepted its filing of Fampridine-SR (4-aminopyridine) to treat multiple sclerosis, and granted it a priority review. Analyst Phil Nadeau of Cowen & Co. remarked that “the priority review is a positive surprise” and he explained that “with Fampridine on track for FDA approval this year, we think the drug is shaping up to be one of the most interesting product launches for 2009-2010 in small-cap biotech.”
The company resubmitted its new drug application for the compound after receiving a refuse-to-file letter on March 30, in which the regulator cited format issues with the initial submission and requested additional information. Deutsche Bank analyst Mark Schoenebaum commented that “the FDA has accepted the [new drug application] only two weeks after resubmission in what is probably the fastest turnaround for a refuse-to-file that we are aware of.” He also speculated that the priority review status could lead to a deal, which other analysts speculated could involve either the sale of the company or licensing of the drug, as early as this summer.
Use of Fampridine-SR in patients with MS was shown in a late-stage study to improve walking speed, and the drug is reported to be the first to reverse a symptom of the disease. Analyst Jason Napodano of Zacks Investment Research forecast that the oral drug could reach sales of $500 million or more per year, if approved.
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