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)
 
 
Delaware
 
000-50513
 
13-3831168
(State or other jurisdiction
 
(Commission
 
(I.R.S. Employer
of incorporation)
 
File Number)
 
Identification No.)
         
   
420 Saw Mill River Road,
Ardsley, NY
 
10502
   
(Address of principal executive offices)
 
(Zip Code)
         
Registrant’s telephone number, including area code:  (914) 347-4300

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

Exhibit No.
Description
99.1
Press Release dated May 2, 2014

 
 

 

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.
 
 
Acorda Therapeutics, Inc.
 
 
 
May 2, 2014
By:
/s/ Michael Rogers
 
 
Name: Michael Rogers
 
 
Title: Chief Financial Officer

 
 

 

EXHIBIT INDEX

Exhibit No.
Description
99.1
Press Release dated May 2, 2014