Acadia Pharma (NASDAQ: ACAD) reported Q3 EPS of ($0.25), versus ($0.12) last year.

ACADIA plans to submit its NUPLAZID NDA for Parkinson’s disease psychosis in the first quarter of 2015. The company had previously planned to submit the NDA near the end of 2014. The decision to move back the planned submission is based on additional time required to complete preparations needed to support the U.S. Food and Drug Administration’s (FDA) review of NUPLAZID. The change in submission timing is not a result of any change to NUPLAZID’s clinical or safety profile, nor is it a result of any interaction with or request for information from the FDA. Additionally, ACADIA reported that it has successfully completed its drug-drug interaction program and its registration stability program.

“While we had hoped to submit our NDA for NUPLAZID near the end of this year, we believe it is prudent to push back our planned submission to the first quarter of 2015,” said Uli Hacksell, Ph.D., Chief Executive Officer of ACADIA. “We are confident in our safety and efficacy data package supporting the NUPLAZID NDA and are working diligently on completing preparations for the NDA submission and review.

“Additionally, the recent decision by the FDA to grant Breakthrough Therapy designation for NUPLAZID reinforces the large unmet medical need for the treatment of Parkinson’s disease psychosis and the importance of the NUPLAZID program. With no FDA-approved treatment for Parkinson’s disease psychosis, NUPLAZID has the potential to transform the treatment landscape for patients with this debilitating disorder.”

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