Pozen Crushed by FDA Setback
Updated from 11:51 a.m. EDT
Pozen (POZN), a drug-development firm with no commercial products, had nearly half of its market cap erased after U.S. regulators said they couldn't yet approve the company's proposed treatment for migraines.
The Food and Drug Administration issued what's called an approvable letter for Trexima, meaning certain conditions must be satisfied before the drug can be granted full marketing clearance.
Specifically, the FDA determined that Trexima is effective as an acute treatment for migraine headaches, but requested additional safety information. As a result, Trexima might require new studies.Shares of Pozen plunged $6.87, or 49%, to $7.24 following the announcement. Trading volume was extremely heavy, with 6.7 million shares changing hands two hours into the day. That's more than 15 times the average for a full session. Pozen, Chapel Hill, N.C., is developing Trexima with the U.K.'s GlaxoSmithKline (GSK). The drug's developers plan to ask for a meeting with the FDA as quickly as possible to discuss the approvable letter and determine the next steps they should take. Trexima combines the active ingredient in another migraine drug, Glaxo's Imitrex, and the painkiller naproxen sodium. Naproxen sodium is found in several brand-name prescription and over-the-counter medications, including Anaprox and Aleve.
Select the service that is right for you!COMPARE ALL SERVICES
Jim Cramer and Stephanie Link actively manage a real portfolio and reveal their money management tactics while giving advanced notice before every trade.
- $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
Jim Cramer's protege, David Peltier, identifies the best of breed dividend stocks that will pay a reliable AND significant income stream.
- Diversified model portfolio of dividend stocks
- Alerts when market news affect the portfolio
- Bi-weekly updates with exact steps to take - BUY, HOLD, SELL
All of Real Money, plus 15 more of Wall Street's sharpest minds delivering actionable trading ideas, a comprehensive look at the market, and fundamental and technical analysis.
- Real Money + Doug Kass Plus 15 more Wall Street Pros
- Intraday commentary & news
- Ultra-actionable trading ideas
Our options trading pros provide daily market commentary and over 100 monthly option trading ideas and strategies to help you become a well-seasoned trader.
- 100+ monthly options trading ideas
- Actionable options commentary & news
- Real-time trading community
- Options TV