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Biotech Stock Catalysts for December

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Here's a rundown of which drug and biotech companies will see their stocks move on decisions and panel reviews this December, including Human Genome Sciences and Orexigen.

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The next month is shaping up to be a busy one for US officials reviewing new drug applications and a number of companies will see their shares move based on decisions and recommendations from expert advisers.

Here's a look at some important events -- dates are subject to change.

November 30
The US Food and Drug Administration may make a decision Tuesday on whether Valeant Pharmaceuticals (VRX) and GlaxoSmithKline's (GSK) epilepsy seizure medicine Potiga should be approved. The drug approval would be a big boost for Valeant, which recently merged with Biovail. Even though a panel of FDA expert advisers recommended approval in September, the agency delayed a decision for three months for further review. RBC Capital markets analyst Douglas Miehm predicts another delay, which would push the decision into early next year.

December 1
On Wednesday, an FDA panel will consider whether Glaxo's Avodart use should be expanded to help cut the risk of prostate cancer in some men. The drug is currently approved to treat an enlarged prostate and an approval probably would mean much higher sales. As part of the review, the panel will also consider Merck's (MRK) similar drug, Proscar. In a report today [pdf], FDA staff questioned the benefit of the additional prescription for Avodart.

December 7
Orexigen Therapeutics (OREX) will face a panel of FDA experts that will review its diet pill Contrave. This panel meeting and the FDA staff report that precedes it will be watched widely by investors after two other diet drug applications were rejected by the FDA. Vivus (VVUS) and Arena Pharmaceuticals (ARNA) hope to change the agency's mind and get approval sometime in the future. Shares of Orexigen dropped 23% this year as hopes for a new diet pill approval faded. Look for Orexigen shares to fall even more or surge around this panel.

December 9
The FDA is expected to decide on approval of Human Genome Sciences (HGSI) and Glaxo's Benlysta, which would be the first new lupus drug approved in a half century. This is another biggie, an approval that would create a blockbuster product for Human Genome. Despite getting a positive vote at an FDA panel this month, shares of Human Genome dropped because of fears that the agency will require stern safety warnings on the drug. Clarity on the warning label will be a catalyst for the company's stock movement.

December 10
The agency is expected to decide on expanding use of Cumberland Pharmaceuticals (CPIX) Acetadote for patients with liver failure. Currently, the injectable drug is used to treat poisoning from overdoses of acetaminophen (the generic name for Tylenol). The FDA already delayed a decision on this application back in August.

December 17
Roche faces rescission of the approved use of blockbuster Avastin for breast cancer patients. An FDA panel recommended that back in July on concerns about the drug's effectiveness and the agency already postponed a decision on the matter. Avastin is still approved for other types of cancer but rescinding the breast cancer indication may cost the Swiss company $1 billion in annual sales.

December 29
The agency earlier delayed a decision on MannKind's (MNKD) inhalable fast-acting insulin product Afrezza. Since then, a former MannKind executive accused the company in a lawsuit of covering up troublesome data in a drug study. The company denies any hanky panky. Billionaire company founder Alfred Mann backs this company with a large share of his personal fortune.

December 30
Endo Pharmaceuticals (ENDP) expects to hear on its second application to sell testosterone gel Fortesta. The FDA rejected the application a year ago due to safety concerns. The gel is aimed at helping men with low testosterone.

December 30
Two money-losing small-cap companies, Alimera Sciences (ALIM) and pSivida (PSDV), may hear from the FDA on a priority review of their diabetes drug Iluvien.

Steve Smith's OptionSmith portfolio is +40% in 2010. Take a FREE 14 day trial to get exclusive access to the portfolio and trade alerts emailed to you before every trade. Learn more.


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No positions in stocks mentioned.
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