Scrip is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

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

Acadia's Nuplazid Hits A Review Roadblock, But Not A CRL (For Now)

Executive Summary

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.

You may also be interested in...



Nuplazid Complete Response Letter For Dementia Psychosis Driven By Effectiveness Concerns In Subgroups

Acadia says the US FDA’s view has shifted from what was previously agreed upon for approval of an sNDA for pimavanserin in a broad dementia-related psychosis indication.

US FDA Throws Acadia A Curveball On Nuplazid For Dementia Psychosis

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.

April User Fee Goal Calendar: Forecast Uncertain For Atopic Dermatitis Candidates, Nuplazid; Eohilia Could Be First For Orphan Use

While some of the most prominent applications with user fee goal dates in April could be delayed, thanks to JAK inhibitor safety concerns and US FDA communications, the upcoming month should see more than 15 decisions on applications.

Related Content

Topics

Related Companies

UsernamePublicRestriction

Register

SC143964

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