Acadia to stop trials of antipsychotic drug after it fails schizophrenia study
MSN`s Generic Pimavanserin Receives Approval in the U.S.
Delaware Federal District Court Rules in Favor of Acadia in NUPLAZID
SAN DIEGO — September 18, 2023 – Acadia Pharmaceuticals Inc. (Nasdaq: ACAD) today announced that the U.S. Food and Drug Administration (FDA) has made two changes to the NUPLAZID label that clarify its use in patients with Parkinson’s disease-related hallucinations and delusions, with or without dementia. This update is consistent with the current indication. There are no other findings or changes included as part of the label change.
SAN DIEGO--(BUSINESS WIRE)--Acadia Pharmaceuticals Inc. (Nasdaq: ACAD) announced today that the journal Drug Safety published results from a retrospective analysis finding a lower mortality risk in patients with Parkinson’s disease psychosis (PDP) treated with NUPLAZID® (pimavanserin) compared to other atypical antipsychotics over 12 months and across various subgroups. NUPLAZID is the only medication approved by the U.S. FDA for the treatment of hallucinations and delusions associated with PDP.
Aurobindo's Generic Pimavanserin Receives Approval in the U.S.
SAN DIEGO--(BUSINESS WIRE)--Acadia Pharmaceuticals Inc. (Nasdaq: ACAD), today announced its financial results for the second quarter ended June 30, 2022.
Regulators rejected Acadia’s application to expand Nuplazid coverage into Alzheimer’s-related psychosis, the biotech said, turning away its supplemental NDA with a CRL. The rejection letter indicated the FDA also recommended that Acadia conduct an additional trial in ADP, Acadia said.
Shares of Acadia Pharmaceuticals (ACAD 1.77%) were crashing 35.4% as of 11 a.m. ET on Tuesday. The steep decline came after a Food and Drug Administration (FDA) advisory committee voted 9-3 against recommending approval of pimavanserin in treating Alzheimer's disease psychosis.
MSN Lab's Generic Pimavanserin Receives Tentative Approval in the U.S