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): November 20, 2017
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:
☐ 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 November 20, 2017, Acorda Therapeutics, Inc. (the “Company”) issued a press release announcing that it is discontinuing its clinical development program for tozadenant, an investigational treatment for Parkinson’s disease, including immediately discontinuing dosing of all participants currently enrolled in its tozadenant studies. The Company made this decision based on new information obtained from the Phase 3 program related to previously disclosed agranulocytosis and associated serious adverse events. After analyzing this additional information, the Company concluded that it could not be confident that weekly white blood cell count screening would sufficiently ensure patient safety. The Company has informed regulatory authorities and trial investigators regarding the orderly closure of ongoing studies. Over 90% of the participants in the placebo-controlled Phase 3 efficacy and safety study, CL-05, have completed the study. The Company expects data from these participants in the first quarter of 2018 and to present these at appropriate medical/scientific venues. 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
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Exhibit No.
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Description
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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.
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Acorda Therapeutics, Inc. |
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November 20, 2017 |
By: |
/s/ David Lawrence |
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Name: David Lawrence |
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Title: Chief, Business Operations and Principal Accounting Officer |