10 Biotech Stocks Facing FDA Judgment Day

In short, Satraplatin should be a slam-dunk, no-risk approval. Of course, nothing with the FDA is easy. The agency decided to hold an advisory panel meeting to discuss Satraplatin on July 24. Why the FDA made this decision is not clear, but it promises to introduce some volatility to GPC shares in advance of the Aug. 15 deadline.

Omrix Pharmaceuticals(OMRI Quote)
Drug/indication: Thrombin for hemostasis
FDA decision date: Sept. 6

Omrix is an interesting story in that its main competitor, Zymogenetics(ZGEN Quote), is expecting an FDA decision on its own hemostasis drug, rThrombin, on Oct. 18.

We've got a case of dueling thrombins, which are used primarily by surgeons to stop bleeding during surgical procedures. Omrix's Thrombin is derived from human blood and the company will market the product through a partnership with Johnson & Johnson(JNJ Quote). Zymogenetics' rThrombin is a recombinant product, which might make it safer and easier to store and use.

Elan(ELN Quote) and Biogen Idec(BIIB Quote)
Drug/indication: Tysabri for Crohn's disease
FDA decision date: Oct. 15

There isn't much debate that Tysabri works in Crohn's disease. The unresolved issue is the drug's safety given the connection between Tysabri use and the often-fatal brain disorder progressive multifocal leukoencephalopathy.

Expect this topic to be a big focus of an FDA advisory panel meeting scheduled for July 31. Tysabri is already approved as a treatment for multiple sclerosis, so a second approval in Crohn's disease would be a meaningful boost for Elan and Biogen Idec.