plumiaz_report-050114.htm
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): May 2, 2014
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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420 Saw Mill River Road,
Ardsley, NY
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10502
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(Address of principal executive offices)
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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 May 2, 2014, Acorda Therapeutics, Inc. (the “Company”) issued a press release announcing that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) for the New Drug Application (NDA) for PLUMIAZTM (diazepam) Nasal Spray for the treatment of people with epilepsy who experience cluster seizures. A CRL is a communication from the FDA that informs a company that their review of the NDA is complete and the application cannot be approved in its present form. The Company is currently developing a response to address the items outlined in the letter. A copy of the press release is attached as Exhibit 99.1 to this Current Report on Form 8-K, and incorporated by reference into this Item.
Item 9.01 Financial Statements and Exhibits
(d) Exhibits
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Exhibit No.
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Description
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99.1
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Press Release dated May 2, 2014
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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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May 2, 2014
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By:
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/s/ Michael Rogers
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Name: Michael Rogers
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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 May 2, 2014
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