Key Developments: Acorda Therapeutics Inc (ACOR.OQ)

ACOR.OQ on NASDAQ Stock Exchange Global Select Market

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1 Aug 2013
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Latest Key Developments (Source: Significant Developments)

Acorda Therapeutics Inc Reaffirms FY 2013 AMPYRA Net Revenue Guidance
6:00am EDT 

Acorda Therapeutics Inc announced that it is reiterating fiscal 2013, AMPYRA net revenue guidance of $285-$315 million.  Full Article

Acorda Therapeutics Inc Completes Acquisition Of two neuropathic pain management assets from NeurogesX, Inc-Fom 8-K
Tuesday, 9 Jul 2013 07:30am EDT 

On July 8, 2013 Acorda Therapeutics Inc (Acorda) reported in its Form 8-K that it has completed the acquisition of two neuropathic pain management assets from NeurogesX, Inc. (NeurogesX), including: Qutenza, which is approved by the U.S. Food and Drug Administration (FDA) for the management of neuropathic pain associated with postherpetic neuralgia; and NP-1998, a Phase 3 ready, prescription strength capsaicin topical solution, being assessed for the treatment of neuropathic pain. NP-1998 was previously referred to as NGX-1998. Acorda made an approximately $8 million payment to acquire development and commercialization rights for Qutenza and NP-1998 in the United States, Canada, Latin America and certain other territories, including $7 million paid to NeurogesX and approximately $900,000 for certain assumed accounts payable. Acorda will also make up to $5 million in payments contingent upon the achievement of certain regulatory and sales milestones related to NP-1998.  Full Article

Acorda Therapeutics Inc Announces Issuance of Additional U.S. Patent for AMPYRA Covering a Range of Dosage Strengths
Monday, 20 May 2013 07:00am EDT 

Acorda Therapeutics Inc announced that the United States Patent and Trademark Office (USPTO) has issued U.S. Patent Application No. 8,440,703 ("the `703 patent") entitled "Methods of Using Sustained Release Aminopyridine Compositions." The `703 patent includes claims directed to methods of improving lower extremity function and walking and increasing walking speed in patients with multiple sclerosis (MS) by administering less than 15 mg of sustained release 4-aminopyridine (dalfampridine) twice daily. The `703 patent is set to expire in 2025. This patent is eligible for listing in the U.S. Food and Drug Administration (FDA) Orange Book. The `703 patent is separate from the two AMPYRA method of use patents issued by the USPTO in 2011 and 2013 that are set to expire in 2027 and 2026, respectively. AMPYRA is approved in the United States as a treatment to improve walking in patients with multiple sclerosis (MS). This was demonstrated by an improvement in walking speed. AMPYRA is known as prolonged-, modified-, or sustained-release fampridine (FAMPYRA) in some countries outside the United States.  Full Article

Acorda Therapeutics Inc Announces Positive AMPYRA (dalfampridine) Phase 2 Data In People With Post-Stroke Deficits
Monday, 15 Apr 2013 06:00am EDT 

Acorda Therapeutics Inc announced that a proof-of-concept trial found dalfampridine extended release (ER) tablets, marketed as AMPYRA (dalfampridine) Extended Release Tablets, 10 mg, improved walking in people with post-stroke deficits. Post-stroke deficits refer to chronic neurological deficits, such as impaired walking, motor and sensory function and manual dexterity that persist in people who have had a stroke. This study included 83 participants who had experienced an ischemic stroke at least six months prior to enrollment and had chronic motor deficits. As part of the crossover design, participants received both dalfampridine-ER 10 mg and placebo for 14 days twice daily, with a wash-out period in between during which participants received placebo. The primary goals of the study were to assess safety and tolerability, as well as to explore various efficacy measures. The safety findings in this study were consistent with previous clinical trials and post-marketing experience of AMPYRA in multiple sclerosis (MS). The most common adverse events reported in the study were dizziness (10.4% dalfampridine-ER, 2.5% placebo), nausea (3.9% dalfampridine-ER, 6.2% placebo), fatigue (5.2% dalfampridine-ER, 3.7% placebo), insomnia (5.2% dalfampridine-ER, 2.5% placebo) and arthralgia (2.6% dalfampridine-ER, 3.7% placebo).  Full Article

Acorda Therapeutics Inc Completes Acquisition Of Neuronex, Inc.
Friday, 21 Dec 2012 06:00am EST 

Acorda Therapeutics Inc announced that the Company has completed the acquisition of Neuronex, Inc., a privately held company developing a nasal spray formulation of diazepam. Under the terms of the agreement, Acorda paid $6.8 million to Neuronex to complete the acquisition.  Full Article

Investigation Of Acorda Therapeutics, Inc. By Securities Lawyers At Goldfarb LLP Law Firm For Potential Shareholder Claim
Tuesday, 5 Jun 2012 02:04pm EDT 

Goldfarb LLP announced that it is investigating whether the Board of Directors of Acorda Therapeutics, Inc. violated shareholder protection laws by allegedly breaching compliance matters concerning adverse drug experience reporting, prompting an investigation by the FDA.  Full Article

Acorda Therapeutics Announces Investigation Of Acorda Therapeutics, Inc
Monday, 4 Jun 2012 11:00am EDT 

Acorda Therapeutics announced that it is investigating possible breaches of fiduciary duty and other violations of the law by certain officers and directors at Acorda Therapeutics, Inc. Robbins Umeda LLP is investigating whether officers and directors of Acorda Therapeutics breached their fiduciary duties to shareholders by permitting insufficient controls and improper procedures concerning adverse drug experience reporting and related compliance matters with the Food and Drug Administration (FDA). On May 10, 2012, the FDA sent the Company a warning letter outlining Acorda's six year history of failing to comply with ADE protocols, based on FDA inspections conducted in 2006, 2009, and the fall of 2011. The letter specifically described repeat violations committed by the Company, including failure to timely submit serious and unexpected ADEs to the FDA, including ADEs pertaining to patients taking Ampyra, the Company's multiple sclerosis treatment, and failure to develop written procedures and maintain required records pertaining to ADEs. In addition, the FDA's warning letter described false information reported by Acorda to the FDA with respect to corrective actions that were not completed until 2007 despite the Company's January 19, 2006 report to the FDA stating that all corrections had been made.  Full Article

Acorda Therapeutics Presents Preclinical Data Showing Dalfampridine Improves Motor Function in Chronic Stroke
Friday, 3 Feb 2012 07:00am EST 

Acorda Therapeutics presented data showing that treatment with dalfampridine improved motor function in a preclinical model of stroke, with treatment initiated at least four weeks following the ischemic event. These data were presented on February 2 at the American Heart Association/American Stroke Association International Stroke Conference in New Orleans, LA. Dalfampridine, also known as 4-aminopyridine, is the active chemical ingredient in AMPYRA (dalfampridine) Extended Release Tablets, 10 mg. A late-breaking science presentation, entitled “Dalfampridine Improves Sensorimotor Function in Rats with Chronic Deficits Following Middle Cerebral Artery Occlusion,” presented by Acorda scientist Jennifer Iaci, reviewed data from three study groups that received treatment beginning four weeks after a permanent middle cerebral artery occlusion (pMCAO). The neurological impairments that result are expected to be permanent by four weeks, which represents the chronic stage of stroke. Each group received three treatment phases over the course of the study: high and low doses of dalfampridine, and placebo. The order of the treatment phases was different for each group, with a 10 day washout period between each phase.  Full Article

Acorda Therapeutics Announces Preclinical Data on GGF2 in Heart Failure
Wednesday, 16 Nov 2011 07:00am EST 

Acorda Therapeutics, Inc. announced that preclinical data from a study of its investigational drug Glial Growth Factor 2 (GGF2) showed GGF2 significantly improved ventricular function in a heart failure model in swine. GGF2 is currently being evaluated as a treatment for heart failure in a Phase 1 clinical trial. These data were presented at the American Heart Association Scientific Sessions 2011 being held in Orlando, Florida. These data extend previous preclinical study findings that GGF2 improves heart function in preclinical models of heart failure.  Full Article

Acorda Therapeutics Announces Data On AMPYRA
Friday, 21 Oct 2011 06:00am EDT 

Acorda Therapeutics announced data from two new analyses of AMPYRA (dalfampridine) Extended Release Tablets, 10 mg, presented at the 5th Joint Triennial Congress of the European and Americas Committees for Treatment and Research in Multiple Sclerosis (ECTRIMS and ACTRIMS), being held in Amsterdam, the Netherlands. One poster presented an analysis of safety and efficacy data from open-label extension trials that included patients taking AMPYRA for up to five years; a second poster analyzed one year of post-market safety data from AMPYRA in the United States. AMPYRA is known as prolonged-, modified, or sustained-release fampridine (FAMPYRA) in some countries outside the United States. The poster also presented safety findings from all 483 participants who enrolled in extension studies after participating in either MS-F203 or MS-F204. The tolerability profile reported in the extension studies was similar to that seen in Phase 3 placebo-controlled trials of AMPYRA, with the most common adverse events being urinary tract infection, falls, MS relapse, arthralgia, and peripheral edema. In a sub-analysis of the 348 extension study participants treated with AMPYRA in the Phase 3 trials, four seizure-related events were reported.  Full Article

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