JAZZ – This will likely be the last week that JAZZ tops the watchlist for a while.  As we all likely know, the FDA’s Advisory Panel voted 2 Yes – 20 No to recommend the approval off JZP-6 for the treatment of severe fibromyalgia.  JAZZ resumed trading in after hours on Friday, and after an initial dip to $5.90 was able to stabilize in the mid-$7 range.  I expected a bit more panic and a lower trading price.  One theory is that many of those who opened a short position were covering immediately falsely driving the price of JAZZ up.  However, the $7 range is more appropriate for JAZZ, as it already does market its drug Xyrem, and nets sales of over $40M per quarter.  Regardless, I do expect increased panic and selling on Monday, as JAZZ has no near term catalysts and many traders will be making their exits.  The 2-20 vote leaves virtually no possibility for FDA approval in October.

CPIX - After hours CPIX dropped one of the bombs that FDA Catalyst traders fear the most- DELAY. I immediately sent out a rarely used alert to my subscribers (its free, so it you are not signed up make sure yo do so in the box on the upper right of this page or via this LINK).  The new PDUFA date will be in December. Combine this delay with a less than impressive Q2 earnings, and things are not looking good for CPIX.

QCOR – The next PDUFA on the list is QCOR (9/11/10).  I feel that QCOR has an excellent chance of approval (see article here).  Those who purchased $12.50 Sept QCOR Calls were rewarded with a 100% gain, as the price has quickly rebounded from $.15 per contract to $.35 (133% gain). (Yet another reason to sign up for the email list -LINK- ) QCOR should see some more media attention and interest from traders as we near its PDUFA date.

ARNA - Next up on the FDA Panel list is ARNA.  How will it react to yet another takedown by an advisory panel (JAZZ)?  I’m guessing that it will just motor through and potentially begin a run-up through $8 as the panel nears.  The $8 billion dollar weightloss market is just too appealing, and Arena has been picked by many analysts to have the best odds of approval.

OREX - As ARNA begins its run-up, expect OREX to gain some momentum as well.  OREX is in an interesting position, as I feel it may benefit from both a positive or negative panel vote for ARNA on 9/16/10- more on that later.

EDIT - EPCT has just announced it received a “Refusal to File” letter from the FDA.  It is currently down 40%.

Tags: arna, CPIX, JAZZ, OREX, qcor