Acorda Therapeutics, Inc. (NASDAQ:ACOR) Files An 8-K Other Events
Item 8.01Other Events
On June 5, 2017, Acorda Therapeutics, Inc. (the Company) issued a
press release announcing that the Company presented data from its
Phase 3 SPAN-PD clinical trial of CVT-301 (levodopa inhalation
powder) that showed a statistically significant, clinically
meaningful improvement in motor function, as measured by the
Unified Parkinsons Disease Rating Scale Part III (UPDRS III) in
people with Parkinsons experiencing OFF periods. Multiple
secondary endpoints, including achievement of an ON state with
maintenance through 60 minutes and Patient Global Impression of
Change (PGIC), were supportive of the primary endpoint result.
These findings are being presented at the International Congress
of Parkinsons Disease and Movement Disorders (MDS), being held in
Vancouver, British Columbia from June 4-8, 2017. In addition to
the data presented at the MDS congress, the Company announced
interim data from an ongoing long-term safety study
(CVT-301-005). The Company is developing CVT-301 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 Company plans to file a
New Drug Application (NDA) for CVT-301 with the U.S. Food and
Drug Administration (FDA) by the end of the second quarter of
2017, and a Marketing Authorization Application (MAA) with the
European Medicines Agency (EMA) 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 5, 2017 |
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.
