An update on Acadia Pharmaceuticals

01-03-2014 Seeking AlphaComments (0)

ACADIA PharmaceuticalsPharmaceutical

At its fourth quarter earnings conference call, Acadia Pharmaceuticals (ACAD) provided an update on its clinical and regulatory programs. These include the ongoing stability testing of the three registration batches of pimavanserin produced in the third quarter of 2013, the ongoing drug-drug interaction studies, the ongoing accumulation of data from the -015 extension study, and the Phase 2 Alzheimer's Disease Psychosis (ADP) trial.

The registration stability testing is designed to comply with ICH guidelines and to meet the regulatory filing requirements for major markets worldwide. As expected, the company now has the initial three months of stability on the registration lots of pimavanserin, and the data appears to be consistent with what was seen earlier with the stability of the clinical trial formulation. Long-term stability of pimavanserin in the clinical trial formulation was previously established covering a three-year period. The initial stability data from the registration

 

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