What: Shares of Acadia Pharmaceuticals (ACAD -1.47%), a clinical-stage biopharmaceutical company focused on disorders of the central nervous system, were up more than 16% in late afternoon trading today on heavy volume after the company released good news related to its pending New Drug Application, or NDA, with the FDA.
So what: The company announced that its NDA filing for its drug Nuplazid, which was submitted earlier this year as a potential treatment for Parkinson's disease psychosis, has been accepted for priority review by the FDA. A priority review designation accelerates the timeline for review from 10 months to six months from the date of acceptance of filing, and thus a target action date of May 1, 2016 has been set.
Given the good news of a faster review timeline, investors in the company got excited today and bid up it shares accordingly.
Now what: There is a huge need for drugs that treat Parkinson's disease psychosis since an estimated 40% of patients with Parkinson's disease develop psychosis. Given that there are 5 to 7 million patients around the world with the disease, it is truly a huge problem, so if Nuplazid can help treat the disease, it could certainly be a revenue boom for the company.
In clinical trials, Nuplazid was able to meet its primary and secondary efficacy endpoints in treating the disease, with no worsening of motor function. Based on the results, the FDA designated Nuplazid with the Breakthrough Therapy designation, so odds look favorable that it will be approved next year.
Given the huge potential for Nuplazid and the good news about the accelerated review, I certainly think the market was right to bid up shares today.
