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Acorda Therapeutics Inc (ACOR.O)

ACOR.O on Nasdaq

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17 Nov 2017
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Latest Key Developments (Source: Significant Developments)

Acorda provides update on tozadenant development program
Wednesday, 15 Nov 2017 07:00am EST 

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 06:00am EDT 

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 06:00am EDT 

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

Acorda Therapeutics announced update on refusal to file letter that it received from U.S. FDA
Wednesday, 27 Sep 2017 07:25am EDT 

Sept 27 (Reuters) - Acorda Therapeutics Inc ::Acorda Therapeutics ‍announced update on refusal to file letter that it received from U.S. FDA regarding its new drug application for Inbrija​.Says it ‍has engaged in a constructive dialogue with FDA to determine most efficient path forward to resubmitting Inbrija NDA​.Acorda Therapeutics - ‍based on interactions with FDA, co believes it can resubmit without a type a meeting, and therefore will not request such a meeting​.Acorda Therapeutics - ‍reiterated that issues raised in RTF are addressable and that FDA has not requested or recommended additional clinical efficacy or safety studies​.Says it ‍plans to resubmit NDA for ‍Inbrija​ as soon as possible​.  Full Article

Acorda adopts Shareholder Rights Plan
Friday, 1 Sep 2017 07:00am EDT 

Sept 1 (Reuters) - Acorda Therapeutics Inc :Acorda adopts Shareholder Rights Plan.Acorda Therapeutics - adopted Shareholder Rights Plan, declared a dividend distribution of 1 preferred share purchase right on each outstanding share.Acorda Therapeutics Inc - ‍ shareholder rights plan is effective September 1, 2017 and will expire on August 31, 2018.Acorda Therapeutics Inc - sets trigger at ‍15 percent​.  Full Article

Acorda receives refusal to file letter from FDA for Inbrija maketing application
Tuesday, 29 Aug 2017 07:00am EDT 

Aug 29 (Reuters) - Acorda Therapeutics Inc :Acorda receives refusal to file letter from FDA for Inbrija™ (CVT-301, Levodopa inhalation powder) new drug application.Acorda Therapeutics - ‍upon prelim review, FDA determined NDA, submitted on June 26, 2017, was not sufficiently complete to permit a substantive review​.Acorda Therapeutics Inc - ‍FDA has not requested or recommended additional clinical efficacy or safety studies​.Acorda - Will seek immediate guidance, including a type a meeting with FDA.Acorda Therapeutics Inc - ‍FDA also requested additional information at resubmission, which was not part of basis for RTF​.Acorda Therapeutics Inc - ‍FDA specified two reasons for refusal to file: first, date when manufacturing site would be ready for inspection​.Acorda Therapeutics Inc - ‍FDA specified two reasons for refusal to file: second, a question regarding submission of drug master production record​.Acorda - To seek meeting with FDA to respond to issues which co believes addressable, to seek clarification of what additional information is required​.  Full Article

Acorda Therapeutics Q2 non-GAAP earnings per share $0.29
Thursday, 27 Jul 2017 06:00am EDT 

July 27 (Reuters) - Acorda Therapeutics Inc :Acorda provides financial and pipeline update for second quarter 2017.Q2 non-GAAP earnings per share $0.29.Q2 GAAP loss per share $0.18.Sees FY 2017 sales $535 million to $545 million.Q2 revenue $131.6 million versus I/B/E/S view $140.1 million.Q2 earnings per share view $0.48 -- Thomson Reuters I/B/E/S.Acorda Therapeutics Inc - company reiterates ampyra 2017 net revenue of $535-$545 million.Acorda Therapeutics Inc - company expects to be cash flow positive in 2017, with a projected year-end cash balance in excess of $200 million.Acorda Therapeutics Inc - company expects to maintain exclusivity of ampyra at least through july 2018.FY2017 earnings per share view $1.97, revenue view $566.0 million -- Thomson Reuters I/B/E/S.  Full Article

Christopher James reports 5.9 pct passive stake in Acorda Therapeutics as of June 27, 2017
Friday, 7 Jul 2017 04:10pm EDT 

July 7 (Reuters) - Acorda Therapeutics Inc ::Christopher M. James reports a 5.9 percent passive stake in Acorda Therapeutics Inc as of June 27, 2017- sec filing.  Full Article

Acorda submits new drug application to U.S. Food And Drug Administration
Thursday, 29 Jun 2017 04:01pm EDT 

June 29 (Reuters) - Acorda Therapeutics Inc ::Acorda submits new drug application to U.S. Food And Drug Administration for inbrijatm (CVT-301, levodopa inhalation powder).Acorda Therapeutics Inc - trade name for CVT-301, inbrija, has been conditionally accepted by FDA.Acorda Therapeutics Inc - co anticipates FDA to inform acorda by end of September if submission has been deemed complete and permits a full review.Acorda Therapeutics Inc - plans to file a marketing authorization application (MAA) in EUROPE for CVT-301 by end of 2017.  Full Article

Acorda Therapeutics says expects results from Tozadenant phase 3 clinical trial in Q1 2018​
Tuesday, 6 Jun 2017 06:00am EDT 

June 6 (Reuters) - Acorda Therapeutics Inc :Acorda Therapeutics Inc - expects results from an ongoing tozadenant phase 3 clinical trial in q1 2018​.Acorda Therapeutics Inc - ‍ company initiated an open-label, long-term safety study for Tozadenant in Q2 of 2017​.  Full Article