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November 27, 2012
10:34 EDTACADAcadia jumps over 150% following positive trial results
Acadia Pharmaceuticals surged over 150% in mid-morning trading after the company said its Pimavanserin drug for Parkinson's disease succeeded in meeting the primary goal and key secondary goals of a Phase III trial. In the study, which evaluated the efficacy, tolerability and safety of Pimavanserin in patients with Parkinson's disease psychosis, or PDP, Acadia said Pimavanserin met the primary endpoint of the trial by demonstrating highly significant antipsychotic efficacy as measured using the 9-item SAPS-PD scale. In addition, the drug met the secondary endpoint for motoric tolerability and clinical benefits were observed in all exploratory efficacy measures with significant improvements in nighttime sleep, daytime wakefulness and caregiver burden. Roger G. Mills, M.D., Acadia's EVP of Development, commented that "benefits of Pimavanserin were seen by patients, caregivers and investigators, as well as the independent raters." Acadia said it will continue ongoing preparations for a confirmatory Phase III trial, which will use the same design. Acadia is trading up $3.54, or 153.48%, to $5.82 in mid-morning trading.
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June 26, 2015
10:14 EDTACADOptions with decreasing implied volatility
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June 16, 2015
09:02 EDTACADACADIA says Nuplazid 'generally safe, well tolerated' in PD patients
ACADIA Pharmaceuticals announced the presentation of integrated efficacy and tolerability data from its Phase III program with NUPLAZID at the 19th International Congress of Parkinson’s Disease and Movement Disorders held in San Diego. “Data from the integrated analysis of Phase III studies continue to support the potential for NUPLAZID to safely and effectively treat Parkinson’s disease psychosis, a condition for which there is no approved therapy in the United States,” said Roger Mills, M.D., Executive Vice President, Development and Chief Medical Officer. “Furthermore, data from our open-label safety extension studies indicate that long-term administration of NUPLAZID is generally safe and well tolerated in patients with Parkinson’s disease psychosis and that duration of antipsychotic effect may be maintained for longer than the six weeks investigated in our Phase III placebo-controlled efficacy studies.” An integrated analysis was performed on efficacy and tolerability data from two six-week Phase III placebo-controlled clinical trials with NUPLAZID in Parkinson’s disease psychosis. In this large pooled sample of 268 patients from North America, NUPLAZID showed highly significant improvement in psychosis compared to placebo on the 9-item SAPS-PD scale. NUPLAZID demonstrated significant improvement on each of the separate hallucinations and delusions domains and also on secondary psychoses measures, including the Clinical Global Impression-Improvement and the Clinical Global Impression-Severity scales. In addition, NUPLAZID demonstrated significant improvement on nighttime sleep, daytime wakefulness and caregiver burden, representing additional potential clinically impactful benefits. Results were consistent across all subgroups of interest, showing greater improvement with NUPLAZID over placebo regardless of age, sex, race group or MMSE screening score. Pooled analysis of data from all Phase III placebo-controlled clinical trials with NUPLAZID showed that NUPLAZID was well tolerated and had no impairment on motor function. The adverse event profile of NUPLAZID was similar to placebo.

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