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Many growth investors who have an increased appetite for risk are attracted to the enormous potential biopharma companies bring to the table. That said, I wanted to examine how two biotech firms have performed compared to not only the biotech sector as a whole, but to the S&P 500 as well.

Galena Biopharma, Inc. (NASDAQ:GALE) - Shares of GALE closed up almost 2.51% at the close of Friday's trading session, making the stock very attractive at these levels. Currently trading in a 52-week range of $0.36/share and $3.54/share, Galena Biopharma has continued to trade in a positive manner since October 26th when positive clinical data regarding Neuvax was released.

"Galena Biopharma said earlier today that it presented data from the Phase 1/2 clinical trial of NeuVax at the Society for Immunotherapy of Cancer. The results showed a total of 26 patients receiving NeuVax had at least two CTC measurements made during the vaccine treatment. In 16/26 NeuVax treated patients; the CTCs decreased during the time of treatment, corresponding with an increase in the patients' E75-specific CD8+ cytotoxic T-lymphocytes and an increase in their delayed type hypersensitivity reactions".

The company, which currently has four separate versions of its NeuVax (E75) drug and a single version of its Folate Binding Protein (E39) in its pipeline, has a primary focal point of cancer based immunotherapies. In the wake of the FDA considering a faster approval time for patients with critical needs, I strongly believe that the window to accumulate shares of GALE is shrinking with every passing day as more comprehensive results are due out in early December.

Orexigen Therapeutics, Inc. (NASDAQ:OREX) - Shares of OREX closed down almost 0.25% at the close of Friday's trading session, making the stock very attractive at these levels. Currently trading in a 52-week range of $1.22/share and $7.73/share, Orexigen Therapeutics has been down roughly 1.3% over the last few trading sessions. The primary focal point for OREX (though a joint venture with Takeda) happens to be obesity solutions, which makes the company a player in a market that has already seen FDA approvals for both VIVUS (NASDAQ:VVUS) and Arena Pharmaceuticals (NASDAQ:ARNA).

When it comes to Orexigen and its presence in the weight-loss drug sector, investors should note that, "the company announced on October 22nd that Contrave - the third weight-loss drug facing the FDA this year - may be eligible for an accelerated review and approval process. As of September 30, OREX had 108.3M in cash, equivalents and marketable securities (Orexigen also reported preliminary 3Q financials), and this week's stock offering may raise as much as $65M in net proceeds. The company is on solid ground financially, and OREX price action now relies heavily on the company`s discussions with the FDA. Any concrete evidence that Orexigen will be permitted to resubmit the Contrave New Drug Application ahead of an interim analysis from the Light Study will galvanize investors".

If Orexigen is allowed to resubmit its Contrave application ahead of the Light Study, the stock has the potential to pop 10%-15% (on the conservative side) based on that news. I believe that the window of opportunity is shrinking for both existing shareholders and potentially new shareholders in terms of acquiring shares at these levels.

Comparative Index Performance

For investors who possess that increased appetite for risk, the year-to-date performance of these two companies, especially when compared to three major U.S.-based benchmark indexes, is nothing less than impressive. Since January 1st OREX has demonstrated an impressive gain of 212.60%, whereas Galena has also demonstrated a stellar gain of 381.90%. If we look at the Dow Jones Industrial Average (NYSEARCA:DIA), S&P 500 (NYSEARCA:SPY), and NASDAQ (NASDAQ:QQQ) investors have only seen returns of 5.47%, 10.75%, and 14.43%, respectively.

Final Analysis

In terms of both Galena and Orexigen, the FDA is the key catalyst. If the FDA speeds up its approval process for drugs it deems 'critical', NeuVax has the potential to be approved much earlier than expected. If the FDA decides against this process, I still think GALE has great potential based on recent clinical data. In the case of Orexigen, the FDA actually holds the company's fate in its hands. An application approval could mean great things for investors, any hint at a rejection would force me to jump ship.

Source: 2 Biotech Stocks I'm Considering In The Near-Term