Jazz Pharma rejected for Fibramyalgia Drug by FDA vote 20-2

4-hydroxybutanoic-acidImage via Wikipedia Okay I'm not going to write an article about woulda coulda shoulda. But Jazz was shot down today heavily by the FDA by a vote of 20-No 2 Yes. Mostly due to concerns over abuse of the JZP-6 sodium oxybate drug which is highly similar to GHB. GHB was banned altogether by the FDA in 1990 and is viewed to have no medical benefits in the US.

With that being said Wednesday after the notes were released Jazz was trading at a high of 11.68, bottomed out at 10.23 yesterday, went up in before hours trading this morning and will crumble on Monday's opening. Jazz could go as low as 5-6 range. I'm guessing more along the 7-8 range myself, but that's being optimistic. Currently in After Hours Trading JAZZ is down at 7.53 -2.70 a 27% loss.
But that is this game we play and the FDA doesn't mess around. If you can't take the heat.....

On a positive note, there are plenty of great options available right now. Don't hesitate to move money into the following stocks.










10. QCOR

11. ELN

I really like these for a nice run up before decisions come down in the next coming months. And recoup some losses accrued from the Jazz debacle that will take place on Monday. With that being said making that trade for Jazz Wednesday would have been nice to free up some money for Friday's Top Performing Biotech and Pharmaceuticals stock list.

If you have made a big loss on Jazz make sure to write it off on your taxes. It happens and unfortunately the FDA controls the dice in this game. But I might hold onto Jazz to see what they might do with the recommendations given during the FDA review today. Jazz can implement some plans for safety concerns and maybe turn things around. The panel simply wanted more Safety Data on REMS and did not want the drug to have separate names for Xyrem. There were many positive aspects given in support of Jazz, but this is a really conservative FDA panel these days and it is another Vivus type trade where there are immense benefits but there are too many safety concerns for approval. But it's a bad day for Jazz to say the least.

Top Performers in Biotech for Friday August 20th.

1. Nile Therapeutics NLTX 0.53 +0.11 25.98% gain

2. Otix Global OTIX 4.00 +0.51 14.61% gain

3. Chelsea Therapeutics Int. CHTP 4.06 +0.47 13.09% gain

4. Biolase Technology BLTI 1.05 +0.09 9.38% gain

5. Harbor BioSciences HRBR 0.24 +0.01 6.09% gain

6. Exelixis Inc. EXEL 3.12 +0.14 4.70% gain

7. Sangamo BioSciences SGMO 3.45 +0.13 4.70% gain

8. Generex Biotechnology GNBT 0.42 +0.01 3.56% gain

9. Response Genetics RGDX 2.49 +0.08 3.49% gain

10. PROLOR Biotech PBTH 6.26 +0.20 3.31% gain

Top Performing Pharmaceuticals Friday August 20th

1. MELA Sciences MELA 6.87 +0.62 9.92% gain

2. Access Pharmaceuticals ACCP 2.10 +0.10 5.00% gain

3. SCOLR Pharma DDD 0.45 +0.02 4.66% gain

4. Caracoa Pharmaceuticals CPD 5.90 +0.26 4.61% gain

5. Jiangbo Pharmaceuticals JGBO 10.49 +0.39 3.86% gain

6. Pozen Pharmaceutical POZN 7.29 +0.25 3.55% gain

7. Cumberland Pharmaceuticals CPIX 6.02 +0.19 3.26% gain

8. Antares Pharma AIS 1.60 +0.05 3.23% gain
Enhanced by Zemanta

No comments:

Post a Comment

Note: Only a member of this blog may post a comment.