Analysts skeptical about FDA nod for Acadia's Alzheimer's drug

Johnan Academic Preparatory Institute

21/12/2021 13:12

** Brokerages remain skeptical on whether U.S. FDA will
approve Acadia Pharmaceuticals's  ACAD.O  drug Nuplazid after co
announced plans to resubmit its supplemental new drug
application (sNDA) for Alzheimer's disease psychosis in Q1 2022
 urn:newsml:reuters.com:*:nBwbyC0D3a
    ** Mizuho Securities says it is cautious as it appears FDA
prefers that ACAD conduct another trial, but raises target price
to $33 from $26 to account for possibility of earlier additional
sales from drug
    ** RBC Capital Markets and Jefferies also raise PT due to
accelerated timeline but cite skepticism and uncertainty over
new sNDA
    ** Guggenheim, however, cuts rating to "neutral" from "buy"
as it believes a new trial will be needed to support the drug's
approval for Alzheimer's disease psychosis
    ** FDA in April declined to approve ACAD's earlier sNDA for
Nuplazid for dementia-related psychosis, saying its study lacked
statistical significance  urn:newsml:reuters.com:*:nBw2Fqzmda
    ** FDA approved Nuplazid in 2016 for Parkinson's disease
psychosis
    ** ACAD shares down 1.4% at $26.71 premarket
    ** Up to Monday's close, stock had fallen 49% YTD
 

 (Reporting by Leroy Leo)
 ((Leroy.Dsouza@thomsonreuters.com;))