Acorda Therapeutics,Inc. (NASDAQ:ACOR) Files An 8-K Other Events
Item 8.01Other Events

On November 15, 2017, Acorda Therapeutics, Inc. (the “Company”) issued a press release announcing that it has increased the frequency of blood cell count monitoring for participants to weekly in its Phase 3 program of tozadenant for Parkinson’s disease. The Company took this action in response to cases of agranulocytosis, possibly drug-related, and in some cases associated with sepsis and death. Agranulocytosis is the absence of white blood cells, which fight infection. The Company also has paused new enrollment in the long-term safety studies, pending further discussion with the independent Data Safety Monitoring Board (DSMB) and the United States Food and Drug Administration (FDA). Including the previously conducted Phase 2b study, approximately 890 patients have been exposed to tozadenant and 234 have been exposed to placebo. This corresponds to approximately 300 patient years of tozadenant exposure and 75 patient-years of placebo. There have been seven cases of sepsis, all in the tozadenant groups, five of which were fatal. Four of the sepsis cases were associated with agranulocytosis, two had no white blood cell counts available at the time of the event and one had a high white blood cell count. 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

ACORDA THERAPEUTICS INC Exhibit
EX-99.1 2 acor-ex991_17.htm EX-99.1 acor-ex991_17.htm EXHIBIT 99.1 CONTACT: Investors/Analysts:                                                                                             Media: Felicia Vonella                                                                                                    Tierney Saccavino Investor Relations                                                                                               Corporate Communications (914) 326-5146                                                                                                   (914) 326-5104 [email protected]                                                                               [email protected]   FOR IMMEDIATE RELEASE   Acorda Provides Update on Tozadenant Development Program   • Identified cases of agranulocytosis,…
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About Acorda Therapeutics,Inc. (NASDAQ:ACOR)

Acorda Therapeutics, Inc. is a biopharmaceutical company. The Company is engaged in the identification, development and commercialization of therapies that restore function and recovers the lives of people with neurological disorders. Its commercial products include Ampyra, Fampyra, Zanaflex Capsules and a generic version of the capsules, Zanaflex tablets and Qutenza. Its research and development programs include CVT-301, Dalfampridine, Plumiaz, Neuregulin Program, Remyelinating Antibodies Program, CVT-427 and Chondroitinase Program. Its Ampyra is an oral drug for the treatment to improve walking in patients with multiple sclerosis. Zanaflex Capsules and tablets are used as short-acting drugs for the management of spasticity. Qutenza is a dermal patch for the management of neuropathic pain associated with post-herpetic neuralgia. Its pipeline of neurological therapies addresses a range of disorders, including Parkinson’s disease, chronic post-stroke walking deficits and migraine.