Biotech Stocks Waiting FDA Approval

One sure way to gain in stock market is to bet on Biotech Stocks waiting on FDA Approval. Selling out just before FDA approval is a sure way of generating good profit.  Most of them sell out a portion just before the FDA decision. In case the decision goes against, still they are not in profit.  This is a strategy for Biotech investments for those who wants to play by safe.  For those who can afford to take the beating, just go full swing for the FDA Approval or rejection decision.  

Here is the list of stocks waiting FDA Approval in first half of 2010.

Stock Symbol Drug FDA Approval Date Comments
Xenoport XNPT Horizant for restless leg syndrome Feb. 11, 2010 The FDA rejected Horizant Wednesday night, citing concerns about a potential link between the drug and pancreatic tumors in rats.
Mannkind MNKD Afrezza for diabetes Jan. 16 Waiting for inspections at an insulin manufacturing facility. Last month, Mannkind executives expressed confidence that the FDA would be able to complete its review within weeks.
Salix Pharmaceuticals SLXP Xifaxan for hepatic encephalopathy March 24 FDA will post its review of Xifaxan on its web site on Feb. 19 or 22.
Shire Pharmaceuticals SHPGY Velaglucerase for Gaucher’s disease Feb. 28 If approved, have to compete with well-entrenched and market leader Cerezyme, owned by Genzyme
Amylin Pharmaceuticals AMLN Exenatide once weekly for diabetes March 5 Shares with Alkermes. Exenatide once weekly is a long-acting version of Exenatide, a once-daily injectable diabetes drug marketed by Amylin and Eli Lilly
Alkermes ALKS Exenatide once weekly for diabetes March 5 Shares with Amylin Pharmaceuticals. Exenatide once weekly was developed with Alkermes’ long-acting drug delivery technology; the company will receive royalties on the drug’s sales.
InterMune ITMN Pirfenidone for idiopathic pulmonary fibrosis May 4 The FDA’s review of pirfenidone is expected to post to the agency’s web site on March 5 or March 8.
Somaxon Pharmaceuticals SOMX Silenor for insomnia March 21 The FDA issued a complete response letter for Silenor last December. Somaxon met with the FDA, submitted additional information about the drug’s effect in non-elderly patients and now says the agency has all the data it needs to review the drug and issue an approval decision.
Cell Therapeutics CTIC Pixantrone for non-Hodgkin’s lymphoma April 23 Waiting for new schedule of advisory panel meeting
Dendreon DNDN Provenge for prostate cancer May 1 The FDA has given no indication that it plans to hold an advisory panel meeting to review the Provenge application. A similar panel meeting was held in 2007, which voted to recommend the drug’s approval.
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Pozen POZN Vimovo for pain relief April 30 Vimovo combines an acid inhibitor with a non-steroidal anti-inflammatory drug in a single tablet, intended to provide pain relief with fewer gastrointestinal side effects. AztraZeneca(AZN) is Pozen’s marketing partner for Vimovo.