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): February 20, 2018
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:
☐ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
☐ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
☐ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
☐ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
Indicate by check mark whether the registrant is an emerging growth company as defined in as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).
Emerging growth company ☐
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
On February 20, 2018, Acorda Therapeutics, Inc. issued a press release announcing that the U.S. Food and Drug Administration (FDA) has accepted for filing its New Drug Application (NDA) for INBRIJA. INBRIJA is an investigational inhaled levodopa treatment for symptoms of OFF periods in people with Parkinson’s disease taking a carbidopa/levodopa regimen. Under the Prescription Drug User Fee Act (PDUFA), the FDA has set a target date of October 5, 2018. 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 8.01.
Item 9.01Financial Statements and Exhibits
(d) Exhibits
|
Exhibit No.
|
Description
|
|
99.1 |
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. |
|
|
|
|
|
|
February 20, 2018 |
By: |
/s/ David Lawrence |
|
|
|
Name: David Lawrence |
|
|
|
Title: Chief, Business Operations and Principal Accounting Officer |
2