FDA backs NDA filing for ACADIA's Parkinson's candidate pimavanserin

11 April 2013

US biotech firm ACADIA Pharmaceuticals (Nasdaq: ACAD) saw its shares leap 42.8% to $7.97 in pre-market trading on April 11, when 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 of a New Drug Application for the treatment of Parkinson’s disease psychosis (PDP).

As a result, ACADIA will no longer conduct the Phase III-021 study that was planned as a confirmatory trial and was scheduled to be initiated later this month. Pimavanserin is partnered with Canadian biotechnology firm Biovail which could earn the US group as much as $395.0 million (The Pharma Letter May 5, 2009).

NDA submission near end of 2014

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