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Shares of Acorda Therapeutics, Inc. (ACOR) surged in today's session following a 12 to 1 favorable vote by the the FDA's Peripheral and Central Nervous System Drugs (PCNSD) Advisory Committee regarding Fampridine-SR 10 mg as an effective treatment to improve walking in people with multiple sclerosis (MS). The Panel also voted 10 to 2 (1 abstention) that it is clinically meaningful and can be safe for use.
The Committee also recommended by a vote of 12 to 1 that Acorda be required to evaluate the effects of doses lower than 10 mg twice daily, but by a 10 to 2 vote (1 abstention) that these studies not be required prior to approval.
At the request of the FDA, the Committee discussed possible conditions for use, including for patients with renal impairment or history of seizure. Acorda has proposed a Risk Evaluation and Mitigation Strategy (REMS) program, which could include healthcare professional and patient education around appropriate use of Fampridine-SR.
Ron Cohen, M.D., Acorda Therapeutics President and CEO, noted in a conference call today, "The Committee's recommendation is very important, but it is not binding on the Agency for approval."
He explained, "If Fampridine-SR is approved, we have plans in place for our sales force to insure a successful launch. It would be premature to discuss any specific pricing information until we get an approval, but our current pricing guidance has been between $5,000-$10,000 per patient a year."
Dr. Cohen added, "Assuming that we get approval, we are planning and anticipate additional studies for other possible indications for Fampridine."
JP Morgan said today that it believes the outcome of the FDA panel for Acorda's fampridine-SR was "close to a best-case scenario" and the firm recommends investors buy the stock. The firm sees upside in the stock into the approval and reiterated an Overweight rating.
RBC Capital the Panel's vote removes a major overhang and maintained its Outperform rating for ACOR.
Merriman upgraded ACOR to Buy from Neutral and set a $30-$33 target range on the stock.
Baird upgraded ACOR to Outperform from Neutral and raised its target price to $28 from $24.
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