News | News By Subject | News by Disease News By Date | Search News
Get Our FREE
Industry eNewsletter
email:    
   

FDA Asks ACADIA Pharmaceuticals, Inc. (ACAD) to Skip Late Stage Study and File NDA After Successful Results



4/11/2013 7:35:28 AM

Acadia Pharmaceuticals Inc. (ACAD), a biotechnology company with $5 million in annual sales, rose 43 percent in early trading after saying it will gain a U.S. regulatory review of its lead drug sooner than anticipated. Acadia increased to $11.37 at 9 a.m. New York time. The shares had risen fivefold in the 12 months through yesterday. The San Diego-based company plans to apply for Food and Drug Administration review of pimavanserin by the end of 2014. The FDA agreed Acadia won’t have to conduct a final-phase trial that had been scheduled to begin later this month, the company said today in a statement. Instead, the company can use trial results and supportive data from other studies to seek the review of pimavanserin, which is intended to treat Parkinson’s disease psychosis.

Read at Bloomberg
Read at The Street.com
Read at News Release
Read at Seeking Alpha


comments powered by Disqus
   

ADD TO DEL.ICIO.US    ADD TO DIGG    ADD TO FURL    ADD TO STUMBLEUPON    ADD TO TECHNORATI FAVORITES