Shares of Acorda Therapeutics Inc. (NASDAQ:ACOR) have hit a five month low, after documents posted on the U.S. Food and Drug Administration's Website show that some agency investigators have questioned whether Acorda's proposed MS treatment Fampridine-SR should be approved.
The Company’s drug candidate has completed two positive Phase III clinical trials for the improvement of walking ability in patients with MS.
A government panel is slated to meet on Wednesday to discuss whether the agency should approve the drug. The documents were posted ahead of the meeting as part of the agency's briefing materials.
So is the stage now being set for a bouce?
Some on Wall Street are still feeling bullish about the stock, despite today's flurry of panic driven sales.
Lazard Capital expects the FDA panel to recommend approval of Acorda's Fampridine- SR and would be a buyer of the stock ahead of meeting on October 14. The firm believes the company is well prepared for the safety questions and the firm has reiterated a "Buy" rating on the stock.
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Analysts at Leerink Swann believe that the "hate selling" has happened as expected, but the firm said its confidence in Acorda is "waning" although it is maintaining an "Outperform" rating on the stock.
To analysts at Deutsche Bank, the FDA documents appear to be positive and the firm noted that the FDA does not appear to be worried about Amaya leading to an MS relapse. The firm maintains it's "Buy" rating on Acorda.
Acorda is seeking to have fampridine-SR approved to help improve walking speed in patients with MS. An active ingredient in the product has been suspected of triggering seizures in certain patients when used in high doses.
Interestingly, shares of Biogen Idec Inc.(NASDAQ:BIIB) traded up for the day despite the fact that it has rights to Fampridine-SR outside the U.S.
Acorda is a commercial-stage biopharmaceutical company engaged in the identification, development and commercialization of therapies that improve neurological function in people with multiple sclerosis (MS), spinal cord injury (SCI), and other disorders of the central nervous system (CNS). The Company’s marketed product, Zanaflex Capsules, is approved by the United States Food and Drug Administration (FDA) for the management of spasticity.
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