Gearing up for a springtime FDA submission, Sunovion Pharmaceuticals reported today that its apomorphine sublingual film succeeded in a pivotal Phase III trial in patients with Parkinson’s disease who experience motor fluctuations. Without revealing the study’s full results, the Marlborough, Mass.-based company said that the trial met its primary and key secondary endpoints and that […]
Acorda Therapeutics
Acorda resubmits NDA for inhaled Parkinson’s disease therapy
Acorda Therapeutics (NSDQ:ACOR) said today that it resubmitted its new drug application for Inbrija, an inhaled therapy for people with Parkinson’s disease. The Ardsley, N.Y.-based company was dealt a setback in August when the FDA told Acorda that it wouldn’t review its application for Inbrija, a move that sent ACOR shares tumbling. The FDA’s refusal to […]
Biotech, pharma chime in over Trump’s move to halt immigration program
On Tuesday, biotech and pharmaceutical companies urged president Donald Trump to reconsider his decision to end former president Barack Obama’s policy protecting undocumented immigrants who arrived in the U.S. as children. Attorney general Jeff Sessions said Tuesday morning that Trump would move to halt the Deferred Action for Childhood Arrivals program in six months, unless […]
Acorda shares plunge -30% after FDA refuses to review NDA
Shares in Acorda Therapeutics (NSDQ:ACOR) dropped nearly -30% today after the FDA told the company that the new drug application for its inhaled Parkinson’s disease treatment is incomplete. The FDA’s refusal to file letter surprised analysts. The note from the regulatory agency had to do with the date when the manufacturing site would be ready for […]
Inhaled Parkinson’s treatment improves motor function in Phase III
Shares in Acorda Therapeutics (NSDQ:ACOR) jumped this morning after the company reported that its inhaled Parkinson’s drug significantly improved motor function in a Phase III trial. The investigational drug is being studied as a therapy for people with Parkinson’s disease experiencing “off” periods, or a re-emergence of symptoms. The Phase III Span-Pd trial enrolled 339 patients with […]
Acorda misses on Q1 earnings, slashes expense guidance after restructuring
Shares in Acorda Therapeutics (NSDQ:ACOR) fell today after the biopharmaceutical company missed expectations on Wall Street with its 1st quarter results. The Ardsley, N.Y.-based company posted a net loss of -$18.9 million, or -41¢ per share, on sales of $119.4 million for the 3 months ended March 31. In the same quarter last year, Acorda reported […]
Acorda to cut 20% of staff in restructuring effort
Acorda Therapeutics (NSDQ:ACOR) said today that it plans to cut 20% of its workforce as a part of a cost reduction and restructuring effort. The move comes less than 1 week after the company lost patents related to its multiple sclerosis drug, Ampyra. The Ardsley, N.Y.-based company had 597 employees as of February, according to Reuters, […]
Acorda plans NDA for inhaled Parkinson’s drug after touting long-term safety data
Acorda Therapeutics (NSDQ:ACOR) touted data from 2 ongoing, long-term safety studies of its inhaled Parkinson’s therapy. The trials showed no difference in pulmonary function between the group receiving CVT-301, the inhaled formulation of Parkinson’s drug levodopa, and the control group. The investigational drug is being studied as a therapy for people with Parkinson’s disease experiencing “off” […]
Acorda’s inhaled Parkinson’s drug meets primary endpoint in Phase III trial
Acorda Therapeutics (NSDQ:ACOR) said today that the phase III clinical trial evaluating its inhaled formulation of Parkinson’s drug levodopa met its primary endpoint. The drug was studied as a therapy for people with Parkinson’s disease experiencing “off” periods, or a re-emergence of symptoms. The randomized phase III trial enrolled 339 patients to evaluate the efficacy […]
