** Shares of drug developer ACAD.O up ~11% at $26
** Co says it received target action date of August 4, from
U.S. FDA for a resubmitted marketing application for its drug,
Nuplazid, to treat hallucinations and delusions associated with
Alzheimer's disease psychosis (ADP) urn:newsml:reuters.com:*:nBw1FCT68a
** FDA has also advised co it is planning to hold advisory
committee meeting in connection with its review, ACAD says
** Co last month resubmitted application to the health
regulator to extend use of Nuplazid, which is currently approved
for treating hallucinations and delusions related to Parkinson's
disease psychosis urn:newsml:reuters.com:*:nL4N2T545U
** Brokerage Mizuho says it remains somewhat skeptical FDA
will approve Nuplazid's application in ADP without a new trial
focused on this specific population of patients
** Should FDA ultimately approve application, it would open
up a large potential market opportunity for Nuplazid - brokerage
** ACAD shares were down ~56% in 2021
(Reporting by Manojna Maddipatla in Bengaluru)
((manojna.kalyani@thomsonreuters.com; +91 8061822700;))