Acadia’s Nuplazid Shows Nearly Three-Fold Reduction In Psychosis Relapse
Data presented at the CTAD meeting for pimavanserin in dementia-related psychosis will support an sNDA filing in 2020 for an approval that could broaden the drug’s market exponentially.
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Deficiencies identified by the US FDA could delay the approval of pimavanserin for hallucinations associated with dementia-related psychosis, but Acadia did not have details for investors.
Keeping Track: Keytruda Claims First TMB-Based Cancer Indication; TG Therapeutics Submits First Umbralisib NDA
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker.
After a Phase III failure in refractory schizophrenia, Acadia has Phase II data showing efficacy in negative symptoms of the disease, an unmet need. It plans a pivotal study in 2020.