No new way for Nuplazid after depression failure
As pipeline expansion plans go Acadia Pharmaceuticals is having a tough time of it. Yesterday there was double disappointment after its lead product Nuplazid bombed in a pivotal study in the supplemental indication of major depressive disorder and furthermore failed to secure a priority review from US regulators for its dementia-related psychosis filing. This left the company nursing a 12% share price drop. For long-time followers of Acadia, the less than clear results from the original phase II Clarity study should have raised doubts that two pooled phase III trials would deliver a resounding result. And so it has come to pass. While MDD would not have been a huge money-spinner for Acadia, a win here might have made up for the disappointing sales in Parkinson’s disease psychosis, Nuplazid’s only approved indication. The biggest blow to the stock, however, was arguably the failure to secure a priority review in dementia-related psychosis, which took the shine off the regulator dispensing with the need for an adcom in this indication. PRD is forecast to be the source of the majority of Nuplazid sales, so the drug's Pdufa date, now set for April 3, 2021, cannot come fast enough for Acadia.