FDA Watch: 6 Biotechs Awaiting FDA Drug Approvals in 2011

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(Written by Alexander Crawford. FDA decision data sourced from RTT News, all other data sourced from Finviz.)

2011 has already been a solid year for FDA drug approvals. By late July, the FDA had already matched their 21 new drug approvals made in 2010 with AstraZeneca’s blood-thinner Brilinta.

This year has also seen FDA approval of the first new lupus drug in 50 years with Human Genome Sciences’ Benlysta, and the first new melanoma drug in 13 years with Bristol-Myers Squibb’s Yervoy.

So you may be wondering what else is in store for 2011. Here we list 6 companies awaiting FDA decisions later this year for recently submitted new drug applications (NDAs).

Which of these companies do you think will be receiving good news?

Use this list as a starting-off point for your own analysis.

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List sorted by decision date.

1. Bristol-Myers Squibb Company (BMY): Develops, and delivers innovative medicines that help patients prevail over serious diseases. Market cap of $50.64B. Offers a good dividend, and appears to have good liquidity to back it up--dividend yield at 4.45%, current ratio at 1.99, and quick ratio at 1.79. The stock has gained 17.86% over the last year. Bristol-Myers is expecting an FDA decision by 10/28/11 on Dapagliflozin, proposed to treat adults with type 2 diabetes mellitus.

2. Pacira Pharmaceuticals Inc. (PCRX): Engages in the development, commercialization, and manufacture of pharmaceutical products for hospitals and ambulatory surgery centers. Market cap of $126.47M. The stock is currently stuck in a downtrend, trading 16.16% below its SMA20, 28.54% below its SMA50, and 21.87% below its SMA200. It's been a rough couple of days for the stock, losing 15.63% over the last week. Pacira Pharmaceuticals is awaiting a decision by 10/28/11 for its drug Exparel to treat postsurgical pain.

3. pSivida Corp. (PSDV): Develops drug delivery products that are administered by implantation, injection, or insertion. Market cap of $91.88M. This is a risky stock that is significantly more volatile than the overall market (beta = 2.36). The stock has gained 28.41% over the last year. pSivida is awaiting a decision from the FDA by 11/12/11 for drug ILUVIEN to treat diabetic macular edema.

4. Teva Pharmaceutical Industries Limited (TEVA): Develops, produces, and markets generic drugs; and proprietary branded pharmaceuticals in various therapeutic categories and active pharmaceutical ingredients worldwide. Market cap of $38.80B. The stock has had a couple of great days, gaining 6.78% over the last week. Teva is expecting an FDA decision by 11/14/11 for Bio-T-Gel to treat low testosterone levels in men.

5. BioSante Pharmaceuticals, Inc. (BPAX): Develops products for female sexual health and oncology. Market cap of $282.73M. The stock is a short squeeze candidate, with a short float at 14.07% (equivalent to 5.23 days of average volume). The stock has had a couple of great days, gaining 9.83% over the last week. BioSante is expecting an FDA decision by 11/14/11 for Bio-T-Gel to treat low testosterone levels in men.

6. Regeneron Pharmaceuticals, Inc. (REGN): Develops, and commercializes pharmaceutical products for the treatment of serious medical conditions in the United States. Market cap of $5.45B. The stock is a short squeeze candidate, with a short float at 12.01% (equivalent to 8.43 days of average volume). Exhibiting strong upside momentum--currently trading 18.05% above its SMA20, 16.45% above its SMA50, and 43.05% above its SMA200. The stock has had a couple of great days, gaining 5.63% over the last week. Regeneron is awaiting an FDA decision by 11/18/11 for EYLEA for treating neovascular age-related macular degeneration (Wet AMD).



The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of The NASDAQ OMX Group, Inc.



This article appears in: Investing , Investing Ideas , Stocks

Referenced Stocks: BMY , BPAX , PCRX , PSDV , REGN , TEVA

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