Pozen Pounded on FDA's Trexima Delay
Can Pozen (POZN) do anything right?
The Chapel Hill, N.C.-based drug company has
The first two Pozen drugs are dead; the third, Trexima, is still hanging on, but its fate remains uncertain. Thursday, the FDA said it would require Pozen and partner GlaxoSmithKline (GSK) to collect more safety data before the drug could be approved.
The bad news sent Pozen shares tumbling 45.6% to $9.49 in recent trading. Glaxo's were up 31 cents to $51.92.Thursday, Pozen management said it would take all steps necessary -- and fast -- to satisfy the FDA's concerns so that Trexima can be resubmitted and eventually be approved. The problem is that the clock is ticking. Trexima faces potential competition from cheaper generics entering the market toward the end of 2008. That's why an approval Thursday was so important to Trexima (and Pozen's stock price). Now, Trexima may not make it to market (if at all) before mid-2008, leaving little time for marketing partner Glaxo to get patients on the drug. Trexima combines Imitrex, the leading migraine headache drug marketed by Glaxo, with naproxen, an over-the-counter pain reliever and anti-inflammatory drug. Naproxen, a so-called NSAID (nonsteroidal, anti-inflammatory drug), is probably best known by the brand name 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