After meeting with the U.S. Food and Drug Administration, Acadia intends to file an approval application for pimavanserin based on data from a successful phase III study completed last year, plus other supportive data.
The company will no longer conduct a confirmatory phase III study that was planned to begin later this month.
The FDA approval filing for pimavanserin as a treatment for Parkinson's psychosis is expected near the end of 2014. FDA will subject the pimavanserin filing to a standard review, which suggests a review cycle of 12 months. If approved, pimavanserin could reach the U.S. market in late 2015.Acadia shares are up 25% to $9.94 in pre-market trading. -- Reported by Adam Feuerstein in Boston. Follow Adam Feuerstein on Twitter.
Select the service that is right for you!COMPARE ALL SERVICES
- $2.5+ million portfolio
- Large-cap and dividend focus
- Intraday trade alerts from Cramer
- Weekly roundups
Access the tool that DOMINATES the Russell 2000 and the S&P 500.
- Buy, hold, or sell recommendations for over 4,300 stocks
- Unlimited research reports on your favorite stocks
- A custom stock screener
- Upgrade/downgrade alerts
- Diversified model portfolio of dividend stocks
- Alerts when market news affect the portfolio
- Bi-weekly updates with exact steps to take - BUY, HOLD, SELL
- Real Money + Doug Kass Plus 15 more Wall Street Pros
- Intraday commentary & news
- Ultra-actionable trading ideas
- 100+ monthly options trading ideas
- Actionable options commentary & news
- Real-time trading community
- Options TV