Acorda Therapeutics, Inc. (NASDAQ:ACOR) Files An 8-K Other Events
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 Parkinsons taking a carbidopa /
levodopa regimen. OFF periods refer to the re-emergence of
Parkinsons 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
|
Exhibit No. |
Description |
|
99.1 |
Press Release dated June 29, 2017 |
ACORDA THERAPEUTICS INC ExhibitEX-99.1 2 acor-ex991_18.htm PRESS RELEASE acor-ex991_18.htm EXHIBIT 99.1 CONTACT: Felicia Vonella Acorda Therapeutics,…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.