$ACOR (Acorda Therapeutics, Inc.)

$ACOR {{ '2016-01-20T11:17:43+0000' | timeago}} • Announcement

$ACOR said it will also obtain global rights to SYN120, an oral, 5-HT6/5-HT2A dual receptor antagonist for Parkinson's-related dementia, in Phase 2 development with support from the Michael J. Fox Foundation. In a Phase 2b clinical trial, tozadenant reduced average daily OFF time as an adjunct to treatment regimens including levodopa/carbidopa.

$ACOR {{ '2018-01-08T12:56:05+0000' | timeago}} • Announcement

Bio-pharmaceuticals company $ACOR has reported net sales of $542MM for fiscal 2017. For fiscal 2018, the company expects net sales to be in the range of $330MM to $350MM. R&D and SG&A operating expenses, on an adjusted basis, is forecasted in the $270-$290MM range.

$ACOR {{ '2017-12-07T14:24:01+0000' | timeago}} • Announcement

$ACOR announced the resubmission of its New Drug Application (NDA) for INBRIJA to the US FDA. INBRIJA is an investigational treatment for symptoms of OFF periods in people with Parkinson’s disease taking a carbidopa/levodopa regimen. FDA is expected to inform $ACOR within 74 days if the submission has been deemed complete and permits a full review.

$ACOR {{ '2017-11-20T13:09:44+0000' | timeago}} • Announcement

$ACOR stops developing its Parkinson’s disease drug tozadenant. This decision comes a week after the drugmaker reported five deaths in key studies testing the treatment. The company would stop enrolling patients in two long-term safety trials after it found seven cases of sepsis in mid- and late-stage trials.

$ACOR {{ '2017-11-17T15:46:22+0000' | timeago}} • Announcement

$ACOR announced a $40MM royalty monetization with HealthCare Royalty Partners (HCR) and a $13MM royalty monetization with H. Lundbeck A/S. H. Lundbeck and $ACOR have amended the license agreement for Selincro to eliminate future royalty and milestone obligations on sales of Selincro outside of the United States.

$ACOR {{ '2017-11-15T12:23:57+0000' | timeago}} • Announcement

$ACOR said it has paused new enrollment in the long-term safety studies, pending further discussion with the independent Data Safety Monitoring Board (DSMB) and the United States Food and Drug Administration (FDA).

$ACOR {{ '2017-11-15T12:23:21+0000' | timeago}} • Announcement

$ACOR lifted frequency of blood cell count monitoring for participants to weekly in Phase 3 program of tozadenant for Parkinson's disease. $ACOR took this action in response to cases of agranulocytosis, possibly drug-related, and in some cases associated with sepsis and death. Agranulocytosis is absence of white blood cells, which fight infection.

$ACOR {{ '2017-08-29T11:50:07+0000' | timeago}} • Announcement

$ACOR received a Refusal to File (RTF) letter from the FDA regarding its New Drug Application (NDA) for Inbrija (CVT-301, levodopa inhalation powder). Inbrija is an investigational treatment for symptoms of OFF periods in people with Parkinson's disease taking a carbidopa/levodopa regimen.

$ACOR {{ '2017-06-29T20:59:19+0000' | timeago}} • Announcement

$ACOR submits New Drug Application (NDA) to FDA for Inbrija, a potential therapy for patients with Parkinson’s disease. Acorda Therapeutics plans to file a Marketing Authorization Application (MAA) in Europe for Inbrija by the end of 2017.

$ACOR {{ '2017-06-06T13:47:37+0000' | timeago}} • Announcement

$ACOR 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 Parkinson's Disease Rating Scale - Part III (UPDRS III) in people with Parkinson's experiencing OFF periods.

$ACOR {{ '2017-04-05T15:13:28+0000' | timeago}} • Announcement

$ACOR expects to incur about $8MM of pretax charges for severance and other costs related to its corporate restructuring, primarily during 2Q17. $ACOR expects to be cash flow positive for 2017. The company plans to file a New Drug Application (NDA) for CVT-301 with the FDA in 2Q17.

$ACOR {{ '2017-04-05T15:13:11+0000' | timeago}} • Announcement

$ACOR announced a corporate restructuring to reduce its cost structure, focus resources on its two late-stage programs, CVT-301 and tozadenant, and maximize patient access to AMPYRA at least through July 2018.  $ACOR will reduce headcount by about 20% and expects to realize annualized cost savings of about $21MM beginning in 2Q17.

$ACOR {{ '2017-03-31T17:14:35+0000' | timeago}} • Announcement

$ACOR said the United States District Court for the District of Delaware issued decision to invalidate four patents related to Ampyra (dalfampridine) Extended Release Tablets. The company will appeal the ruling on these patents.

$ACOR {{ '2017-02-22T14:10:35+0000' | timeago}} • Announcement

$ACOR appointed  Catherine D. Strader, to its BoD, effective Feb. 17, 2017. Currently, Strader is the founding partner at Synergy Partners R&D Solutions. He will be up for re-election in 2018.

$ACOR {{ '2017-02-14T20:19:54+0000' | timeago}} • Webcast

$ACOR said that on the pipeline front, CVT-301 and Tozadenant are the top priorities. The company added that it is expecting key pivotal data by 1Q17 for Tozadenant. Therefore, these two are the main priorities by far for $ACOR.

$ACOR {{ '2017-02-14T19:49:06+0000' | timeago}} • Webcast

$ACOR expects its SG&A expense for 2017 to be in the range of $195-205MM, flat from 2016. R&D expense for the quarter was $53.8MM, including $3MM in share based compensation, up from $44MM in 4Q15. The increase in R&D expense was mainly due to R&D expenses for Biotie and increased investments in the late stage development programs.

$ACOR {{ '2017-02-14T11:30:48+0000' | timeago}} • Announcement

$ACOR said the positive phase 3 data from its pivotal trial of Parkinson's disease therapy CVT-301 represents a major milestone for the company. $ACOR plans to file a New Drug Application in 2Q17, pending the results of two long-term safety studies. Data from these studies are expected in 1Q17.

$ACOR {{ '2017-02-14T11:28:16+0000' | timeago}} • Announcement

$ACOR expects 2017 Ampyra revenue of $535-545MM. The company predicts 2017 research and development expenses of $185-195MM and selling, general and administrative expenses of $195-205MM.

$ACOR {{ '2017-02-14T11:26:33+0000' | timeago}} • Announcement

$ACOR's revenue from Ampyra, which will improve walking in patients with multiple sclerosis (MS), for 4Q16 rose 8.4% from last year. About 120,000 people with MS in the U.S. have tried Ampyra since its launch in 2010.

$ACOR {{ '2017-02-14T11:22:44+0000' | timeago}} • Announcement

$ACOR slipped to a 4Q16 loss from a profit last year, due to higher operating expenses, and a provision for income taxes. Net loss was $3.09MM or $0.07 per share compared to a profit of $9.21MM or $0.21 per share last year. Revenue grew to $140.63MM from $130.9MM. Non-GAAP EPS fell to $0.05 from $0.31.

$ACOR {{ '2017-01-09T13:02:45+0000' | timeago}} • Announcement

$ACOR reported Ampyra (dalfampridine) net sales for 4Q16 of $132MM. Full-year net sales for 2016 were $493MM, a rise of about 13% from 2015. For 2017, $ACOR expects Ampyra net sales of $535-545MM, research and development expense of $195-205MM. At year-end 2016, $ACOR sees cash, cash equivalents and investments of about $155MM.

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