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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 Therapeutics Sees FY 2018 Sales $330 Mln To $350 Mln For AMPYRA
Monday, 8 Jan 2018 07:00am EST 

Jan 8 (Reuters) - Acorda Therapeutics Inc ::ACORDA ANNOUNCES 2017 AMPYRA NET SALES AND PROVIDES 2018 FINANCIAL GUIDANCE AT J.P. MORGAN HEALTHCARE CONFERENCE.SEES FY 2018 SALES $330 MILLION TO $350 MILLION FOR AMPYRA.INBRIJA NDA RESUBMITTED IN DECEMBER 2017; INITIAL FDA RESPONSE EXPECTED IN FEBRUARY 2018.YEAR-END CASH BALANCE FOR 2018 IS PROJECTED TO BE OVER $300 MILLION.  Full Article

Acorda Therapeutics Is Exploring A Potential Sale - WSJ, Citing Sources
Friday, 5 Jan 2018 03:39pm EST 

Jan 5 (Reuters) - Acorda Therapeutics Inc ::ACORDA THERAPEUTICS IS EXPLORING A POTENTIAL SALE - WSJ, CITING SOURCES.  Full Article

Acorda Resubmits New Drug Application For INBRIJA
Thursday, 7 Dec 2017 06:00am EST 

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 07:00am EST 

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 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 exploring sale: WSJ

Acorda Therapeutics is exploring a sale of the company, the Wall Street Journal reported, citing people familiar with the matter.