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): June 29, 2017
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. ☐
Item 8.01Other Events
On June 29, 2017, Acorda Therapeutics, Inc. (the “Company”) issued a press release announcing that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for INBRIJATM (CVT-301, levodopa inhalation powder). The Company is developing INBRIJA as a treatment for symptoms of OFF periods in people with Parkinson’s taking a carbidopa / levodopa regimen. OFF periods refer to the re-emergence of Parkinson’s symptoms. The trade name for CVT-301, INBRIJA, has been conditionally accepted by the FDA. The NDA was submitted as a 505(b)(2) application. Based on current guidelines, the Company anticipates the FDA to inform the Company by the end of September 2017 if the submission has been deemed complete and permits a full review. The Company plans to file a Marketing Authorization Application (MAA) in Europe for CVT-301 by the end of 2017. A copy of the press release is attached as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated by reference into this Item.
Item 9.01Financial Statements and Exhibits
(d) Exhibits
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. |
| | |
June 29, 2017 | By: | /s/ David Lawrence |
| | Name: David Lawrence |
| | Title: Chief, Business Operations and Principal Accounting Officer |
EXHIBIT INDEX
