Acorda Therapeutics,Inc. (NASDAQ:ACOR) Files An 8-K Other EventsItem 8.01Other Events
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. |
Description |
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99.1 |
Press Release dated November 20, 2017 |
ACORDA THERAPEUTICS INC ExhibitEX-99.1 2 acor-ex991_6.htm PRESS RELEASE acor-ex991_6.htm EXHIBIT 99.1 CONTACT: Investors/Analysts: Media: Steve Sciuto Jim Golden/Sharon Stern/Aaron Palash Investor Relations Joele Frank,…To view the full exhibit click here
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.