Scrip is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction

US FDA Throws Acadia A Curveball On Nuplazid For Dementia Psychosis

Complete Response Letter Requires More Data

Executive Summary

Acadia strikes out on potential near-term sNDA approval in a broad dementia-related psychosis indication. The firm said the agency’s view has shifted from what was previously agreed upon.

You may also be interested in...



Acadia's Nuplazid Expansion Bid Bites The Dust

Nuplazid is a decent earner for the US biotech in psychosis caused by Parkinson’s disease but following previous failures in Alzheimer's and dementia, the drug has now proved a dud for treating the negative symptoms of schizophrenia.

Keeping Track: Enhertu, Nubeqa Grow With RTOR; Interchangeable Cimerli And Another Nuplazid CRL

The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker

Future Of Acadia’s Nuplazid In Alzheimer’s Psychosis Unclear After CRL

An analyst had suggested that in the event of a thumbs-down from the FDA, the company could end up focusing on other catalysts instead. 

Related Content

Topics

Related Companies

Latest Headlines
See All
UsernamePublicRestriction

Register

SC144113

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Thank you for submitting your question. We will respond to you within 2 business days. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel