Acadia's surprise Nuplazid snag—and subsequent cold shoulder at FDA—beg more questions than answers

On March 3, Acadia Pharmaceuticals expected the first draft of a new label for review from the FDA, one of the final steps on Nuplazid's way to a lucrative new indication. Instead, it got a deficiency letter. And not much more information from the FDA since then.

Nuplazid, currently approved to treat hallucinations and delusions associated with Parkinson’s disease psychosis, had posted impressive phase 3 data in dementia-related psychosis. Investors and analysts were predicting a slam-dunk approval. The FDA accepted Acadia's approval submission in July and said at the time that it wouldn't need an advisory panel review to make its decision by April 3, 2021.