ACADIA makes drugs that treat neurological and central nervous system-related disorders. Currently, the company is developing pimavanserin for the treatment of Parkinson’s disease psychosis, Alzheimer’s disease psychosis, and schizophrenia.
The $934.86 million market-cap company’s performance was sparked by the announcement that its pimavanserin Parkinson’s disease psychosis treatment qualifies for the filing of a New Drug Application (NDA) without requiring the customary final-phase trial that was scheduled to commence later in the month.
For as many as 40 percent of those with advanced-stage Parkinson’s disease, psychosis is a commonly experienced complication, often in the form of visual hallucinations. Furthermore, Parkinson’s-related psychosis can be induced by more or less all drugs used to treat the disease.
In a statement released earlier in the day, the company said that the Food and Drug Administration “has agreed that the data from the pivotal Phase III -020 study, together with supportive data from other studies with pimavanserin, are sufficient to support the filing.”
ACADIA will now have to finish up testing and studies, and plans to submit the NDA request by the end of 2014.
Company CEO Dr. Uli Hacksell was quoted in the company’s statement as being happy with the FDA’s decision, saying that it “will reduce substantially both the time and cost of our PDP development program.”
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