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Acorda Therapeutics Inc (ACOR.OQ)

ACOR.OQ on NASDAQ Stock Exchange Global Select Market

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Latest Key Developments (Source: Significant Developments)

Acorda Resubmits New Drug Application For INBRIJA
Thursday, 7 Dec 2017 

Dec 7 (Reuters) - Acorda Therapeutics Inc ::ACORDA RESUBMITS NEW DRUG APPLICATION FOR INBRIJA™ (CVT-301, LEVODOPA INHALATION POWDER).SAYS RESUBMISSION ADDRESSED TWO ISSUES RAISED IN RECENT REFUSAL TO FILE (RTF) LETTER.SAYS RESUBMISSION ALSO INCLUDED ALL ADDITIONAL INFORMATION REQUESTED BY FDA IN ITS LETTER.SAYS INBRIJA NDA IS BEING SUBMITTED AS A 505(B)(2) APPLICATION.  Full Article

Acorda discontinues Tozadenant development program
Monday, 20 Nov 2017 

Nov 20 (Reuters) - Acorda Therapeutics Inc ::Acorda discontinues tozadenant development program.Says also ‍immediately discontinuing dosing of all participants currently enrolled in its tozadenant studies​.Acorda Therapeutics - ‍decision based on new information obtained from phase 3 program related to previously disclosed agranulocytosis and associated serious adverse events​.Acorda Therapeutics - concluded that it could not be confident that weekly white blood cell count screening would sufficiently ensure patient safety​.Says it ‍has informed regulatory authorities and trial investigators regarding orderly closure of ongoing studies​.Acorda Therapeutics - ‍over 90 percent of participants in placebo-controlled phase 3 efficacy and safety study, cl-05, have completed study​.Acorda Therapeutics - ‍expects data from the participants in q1 of 2018 and to present these at appropriate medical/scientific venues​.  Full Article

Acorda provides update on tozadenant development program
Wednesday, 15 Nov 2017 

Nov 15 (Reuters) - Acorda Therapeutics Inc ::Provides update on tozadenant development program.Identified cases of agranulocytosis, possibly drug-related, in some cases associated with sepsis and death​.Discussions with FDA and DSMB ongoing​.Increased blood cell count monitoring to weekly in ongoing Phase 3 program for tozadenant​.Increased frequency of blood cell count monitoring for participants to weekly in phase 3 program of tozadenant for Parkinson's Disease​.Paused new enrollment in long-term safety studies, pending further discussion with independent data safety monitoring board, FDA​.Including previously conducted Phase 2B study, about 890 patients have been exposed to tozadenant and 234 have been exposed to placebo​.Contingent on input from DSMB and FDA, continue to expect to report efficacy and safety results of double-blind phase 3 study in Q1 of 2018​.There have been seven cases of sepsis, all in tozadenant groups, five of which were fatal​.Four sepsis cases were associated with agranulocytosis in tozadenant groups​.  Full Article

Acorda Therapeutics reports Q3 non-gaap earnings per share $0.43
Tuesday, 31 Oct 2017 

Oct 31 (Reuters) - Acorda Therapeutics Inc ::Q3 revenue $141.1 million versus I/B/E/S view $150.6 million.Acorda provides financial and pipeline update for third quarter 2017.Q3 non-gaap earnings per share $0.43.Q3 gaap loss per share $0.55.Q3 earnings per share view $0.65 -- Thomson Reuters I/B/E/S.Acorda Therapeutics Inc - ‍also on track to announce top-line data from our phase 3 study of tozadenant in q1 of 2018​.Acorda Therapeutics Inc - recorded a non-cash intangible asset impairment charge of $39.4 million in quarter for selincro​.Acorda Therapeutics Inc - ‍reiterates ampyra 2017 net revenue of $535-$545 million​.Acorda Therapeutics Inc - ‍r&d expenses for full year 2017 are expected to be $160-$170 million​.Acorda Therapeutics Inc - ‍reducing its sg&a expense guidance for full year 2017 from $170-$180 million to $160-$170 million​.Acorda Therapeutics Inc - ‍expects to be cash flow positive in 2017, with a projected year-end cash balance in excess of $200 million​.Acorda Therapeutics Inc - ‍"vigorously" pursuing ampyra appeal​.Acorda Therapeutics Inc - ‍plan to resubmit inbrija nda in q4​.  Full Article

Acorda Q3 GAAP loss per share $0.55
Tuesday, 31 Oct 2017 

Oct 31 (Reuters) - Acorda Therapeutics Inc -:Acorda provides financial and pipeline update for third quarter 2017.Q3 non-GAAP earnings per share $0.43.Q3 GAAP loss per share $0.55.Q3 revenue $133 million versus I/B/E/S view $150.6 million.Q3 earnings per share view $0.65 -- Thomson Reuters I/B/E/S.Acorda Therapeutics Inc - ‍also on track to announce top-line data from our Phase 3 study of Tozadenant in Q1 of 2018​.Acorda Therapeutics Inc - recorded a non-cash intangible asset impairment charge of $39.4 million in quarter for Selincro​.Acorda Therapeutics Inc - ‍reiterates Ampyra 2017 net revenue of $535-$545 million​.Acorda Therapeutics Inc - ‍R&D expenses for full year 2017 are expected to be $160-$170 million​.Acorda Therapeutics Inc - ‍reducing its SG&A expense guidance for full year 2017 from $170-$180 million to $160-$170 million​.Acorda Therapeutics Inc - ‍expects to be cash flow positive in 2017, with a projected year-end cash balance in excess of $200 million​.Acorda Therapeutics Inc - ‍"vigorously" pursuing Ampyra appeal​.Acorda Therapeutics Inc - ‍plan to resubmit Inbrija NDA in Q4​.  Full Article

‍Scopia Capital Management LP reports 16.5 pct stake in Acorda Therapeutics as of Aug 4 - SEC filing​
Monday, 7 Aug 2017 

Aug 7 (Reuters) - ‍Scopia Capital Management LP :‍Scopia Capital Management LP reports 16.5 percent stake in Acorda Therapeutics Inc as of August 4 - SEC filing​.Scopia Capital Management - on August 7, 2017, Scopia Capital submitted a letter to the Acorda Therapeutics' board of directors‍​.Scopia Capital Management - shares were acquired for investment purposes in the belief that the shares of common stock of acorda are undervalued.Scopia Capital Management LP says believes that it is time for Acorda Therapeutics to pursue immediate review of all strategic alternatives, including sale of co.Scopia Capital-it "urges" Acorda board to engage actively with parties interested in discussions regarding potential deal & to form special committee.  Full Article

Acorda Therapeutics reports Q4 adj eps of $0.05
Tuesday, 14 Feb 2017 

Acorda Therapeutics Inc : Acorda provides financial and pipeline update for fourth quarter and year end 2016 . Sees FY 2017 ampyra sales $535 million to $545 million . Q4 revenue $140.6 million versus I/B/E/S view $138.7 million . Q4 non-GAAP earnings per share $0.05 . Q4 GAAP loss per share $0.07 . Q4 earnings per share view $0.10 -- Thomson Reuters I/B/E/S . Research and development expenses for full year 2017 are expected to be $185-$195 million. .Ampyra 2017 net sales guidance of $535-$545 million.  Full Article

Acorda announces positive phase 3 clinical trial results for CVT-301
Thursday, 9 Feb 2017 

Acorda Therapeutics Inc : Acorda therapeutics inc - span-pd trial met primary endpoint . Acorda therapeutics inc - new drug application (nda) submission planned for q2 2017 . Acorda announces positive phase 3 clinical trial results for cvt-301 . Acorda therapeutics inc - data from two long-term safety studies expected in q1 2017 . Acorda therapeutics inc - cvt-301 showed statistically significant improvement of motor function compared to placebo .Acorda therapeutics inc - also plans to file a marketing authorization application (maa) in europe by end of 2017 for cvt-301.  Full Article

Arbitral Tribunal confirms Acorda's redemption right regarding Biotie shares
Monday, 26 Sep 2016 

Biotie Therapies Oyj : Arbitral Tribunal confirmed Acorda's redemption right regarding Biotie shares .Biotie shares trading has been terminated.  Full Article

Acorda Therapeutics says on June 1 entered credit agreement with units - SEC filing
Thursday, 2 Jun 2016 

Acorda Therapeutics Inc : On June 1, co, units entered into a credit agreement - SEC filing . Initial availability under facility is approximately $58 million. .Agreement provides company with a three-year senior secured revolving credit facility in maximum amount of $60 million.  Full Article

BRIEF-Acorda Resubmits New Drug Application For INBRIJA

* ACORDA RESUBMITS NEW DRUG APPLICATION FOR INBRIJA™ (CVT-301, LEVODOPA INHALATION POWDER)