Acadia Pharma (ACAD) Delays NUPLAZIDTM NDA Submission

March 11, 2015 4:05 PM EDT

Acadia Pharma (NASDAQ: ACAD) today provided an update on the planned timing of its NUPLAZIDTM (pimavanserin) New Drug Application (NDA) submission.

ACADIA plans to submit its NUPLAZID NDA for the treatment of Parkinson’s disease psychosis in the second half of 2015. The company had previously planned to submit the NDA in the first quarter of 2015. The decision to move back the planned submission is based on additional time required to complete the preparation of systems to support commercial manufacturing and supply and, in turn, 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.

“We have concluded that additional time is needed to complete the readiness of our commercial manufacturing systems,” said Steve Davis, Interim Chief Executive Officer of ACADIA. “While we are very disappointed with the change in timing, we believe that this is the prudent course of action to take. We are working expeditiously to ensure that our systems are robust and ready for FDA review and commercial launch. Importantly, we remain confident in the safety and efficacy package supporting the NDA of NUPLAZID, which received Breakthrough Therapy designation from the FDA last year.”

Separately, ACADIA Pharmaceuticals issued a news release today announcing that Uli Hacksell, Ph.D., has retired as its Chief Executive Officer and resigned from its Board of Directors effective today. Steve Davis, Executive Vice President, Chief Financial Officer and Chief Business Officer of ACADIA, has been appointed as Interim Chief Executive Officer.



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