UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
Date of Report (Date of Earliest Event Reported): April 23, 2009
Acorda Therapeutics, Inc.
(Exact name of registrant as specified in its charter)
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Delaware |
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000-50513 |
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13-3831168 |
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(State or other jurisdiction |
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(Commission |
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(I.R.S. Employer |
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of incorporation) |
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File Number) |
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Identification No.) |
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15 Skyline Drive, Hawthorne, NY |
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10532 |
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(Zip Code) |
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Registrant’s telephone number, including area code: (914) 347-4300 |
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Not Applicable
Former name or former address, if changed since last report
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
o Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
o Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
o Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
o Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
Item 8.01 Other Events
On April 23, 2009, Acorda Therapeutics, Inc. (the “Registrant”) issued a press release announcing that the Registrant had resubmitted its New Drug Application (“NDA”) for Fampridine-SR to the U.S. Food and Drug Administration (the “FDA”). Fampridine-SR is a novel therapy being developed to improve walking ability in people with multiple sclerosis. The Registrant had previously received a Refuse to File letter (the “RTF Letter”) on March 30, 2009, which cited the need to correct “format issues” and requested additional supporting information before the NDA could be accepted for review. Based on subsequent discussions with the FDA, the Registrant believes that all of the FDA’s comments related to the RTF Letter have been addressed. A copy of the release is attached hereto as Exhibit 99.1 and incorporated by reference into this item.
Item 9.01 Financial Statements and Exhibits
99.1 Press Release dated April 23, 2009
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
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Acorda Therapeutics, Inc. |
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April 23, 2009 |
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/s/ David Lawrence |
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Name: David Lawrence |
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Title: Chief Financial Officer |
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Exhibit Index
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Exhibit No. |
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Description |
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99.1 |
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Press Release dated April 23, 2009. |