Acorda Therapeutics,Inc. (NASDAQ:ACOR) Files An 8-K Other EventsItem 8.01Other Events
On September 10, 2018, Acorda Therapeutics, Inc. (the “Company”) issued a press release announcing that the United States Court of Appeals for the Federal Circuit, by a 2-1 vote, has upheld the United States District Court for the District of Delaware’s decision to invalidate four AMPYRA patents. 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.
On September 13, 2018, the Company issued a press release announcing the U.S. Food and Drug Administration (FDA) has extended the Prescription Drug User Fee Act (PDUFA) goal date for its review of the New Drug Application (NDA) of INBRIJATM (levodopa inhalation powder) from October 5, 2018 to January 5, 2019. This extension is related to recent submissions the Company made in response to requests from FDA for additional information on chemistry, manufacturing and controls (CMC). FDA determined that these submissions constitute a major amendment and will take additional time to review. A copy of the press release is attached as Exhibit 99.2 to this Current Report on Form 8-K, and incorporated by reference into this Item 8.01.
Item 9.01 Financial Statements and Exhibits
(d) Exhibits
The following exhibits are filed herewith:
ACORDA THERAPEUTICS INC ExhibitEX-99.1 2 acor-ex991_14.htm PRESS RELEASE 9-10-18 acor-ex991_14.htm EXHIBIT 99.1 CONTACT: Felicia Vonella 914-326-5146 [email protected] FOR IMMEDIATE RELEASE U.S. Court of Appeals for the Federal Circuit Upholds District Court’s Decision to Invalidate AMPYRA® (dalfampridine) Patents ARDSLEY,…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.
