ACADIA tanks as it delays Nuplazid filing; CEO retires unexpectedly

12 March 2015
fda-big

Shares of US biotech firm ACADIA Pharmaceuticals (Nasdaq: ACAD) plunged 22% to 34.70 in after-hours trading, after it announced that it now plans to submit a New Drug application for Nuplazid (pimavanserin) for the treatment of Parkinson’s disease in the second half of 2015. The company has previously planned to file the NDA by end-2014 or first-quarter 2015.

The decision to move back the planned submission is based on additional time required to complete the preparation of systems to support commercial manufacturing and supply and, in turn, to support the US Food and Drug Administration’s review of Nuplazid. The change in submission timing is not a result of any change to Nuplazid’s clinical or safety profile, nor is it a result of any interaction with or request for information from the FDA, the company stressed.

Rosy future had been predicted for Nuplazid

This article is accessible to registered users, to continue reading please register for free.  A free trial will give you access to exclusive features, interviews, round-ups and commentary from the sharpest minds in the pharmaceutical and biotechnology space for a week. If you are already a registered user please login. If your trial has come to an end, you can subscribe here.

Login to your account

Become a subscriber

 

£820

Or £77 per month

Subscribe Now
  • Unfettered access to industry-leading news, commentary and analysis in pharma and biotech.
  • Updates from clinical trials, conferences, M&A, licensing, financing, regulation, patents & legal, executive appointments, commercial strategy and financial results.
  • Daily roundup of key events in pharma and biotech.
  • Monthly in-depth briefings on Boardroom appointments and M&A news.
  • Choose from a cost-effective annual package or a flexible monthly subscription
The Pharma Letter is an extremely useful and valuable Life Sciences service that brings together a daily update on performance people and products. It’s part of the key information for keeping me informed

Chairman, Sanofi Aventis UK

Companies featured in this story

More ones to watch >


Today's issue

Company Spotlight





More Features in Biotechnology