Written by Danny Guttridge

When a biotech company is developing a drug, the process can take ten years or more. There are many steps in the development process, including initial design, testing, changes in design, more testing and application for federal approval. Even if this process is successful, leading to a newly approved drug, there is still no guarantee of its commercial success, which can depend on how Medicare, insurers and doctors interpret the drug's use.

Despite all of these uncertainties, investors still heavily focus on whether a company's new drug will be approved by the FDA.

After all, if the drug is approved and does well after release, the company could see big revenue increases.

Interactive Chart: Press Play to compare changes in market cap over the last two years for the first nine stocks mentioned below.

Business Section: Investing Ideas

For a closer look at companies that are about to receive the all-important FDA decision, we list below drug makers awaiting FDA decisions over the next three months.

Do you think these companies will receive FDA approval?

List sorted by market cap. (Click here to access free, interactive tools to analyze these ideas.)

1. Pfizer Inc. (NYSE:PFE): A biopharmaceutical company, offers prescription medicines for humans and animals worldwide. Market cap at $164.34B

2. Bristol-Myers Squibb Company (NYSE:BMY): Develops, and delivers innovative medicines that help patients prevail over serious diseases. Market cap at $55.84B

3. Gilead Sciences Inc. (Nasdaq:GILD): Engages in the discovery, development, and commercialization of therapeutics for the treatment of life threatening diseases worldwide. Market cap at $35.53B

4. Vertex Pharmaceuticals Incorporated (Nasdaq:VRTX): Engages in the discovery, development and commercialization of small molecule drugs for the treatment of serious diseases worldwide. Market cap at $8.61B

5. Salix Pharmaceuticals Ltd. (Nasdaq:SLXP): Develops, and commercializes prescription drugs for the treatment of gastrointestinal disorders in the United States. Market cap at $3.11B

6. VIVUS Inc. (Nasdaq:VVUS): Engages in the development and commercialization of therapeutic products for underserved markets in the United States. Market cap at $2.04B

7. Cell Therapeutics, Inc. (Nasdaq:CTIC): Engages in the development, acquisition and commercialization of drugs for the treatment of cancer. Market cap at $1.08B

8. ProtalixBioTherapeutics, Inc. (NYSE:PLX): Focuses on the development and commercialization of recombinant therapeutic proteins based on its proprietary ProCellEx protein expression system in the United States. Market cap at $533.96M

9. MAP Pharmaceuticals, Inc. (Nasdaq:MAPP): Focuses on the development and commercialization of inhalation therapies for patients suffering from migraine. Market cap at $476.72M

10. Affymax, Inc. (Nasdaq:AFFY): Engages in the development of drugs for the treatment of serious and life-threatening conditions. Market cap at $456.27M

11. Progenics Pharmaceuticals Inc. (Nasdaq:PGNX): Engages in the development and commercialization of therapeutic products to treat the unmet medical needs of patients with debilitating conditions and life-threatening diseases in the United States and internationally. Market cap is at $329.16M.

12. Furiex Pharmaceuticals, Inc. (Nasdaq:FURX): Engages in the compound partnering business in the United States and Europe. Market cap is at $241.49M.

13. Chelsea Therapeutics International Ltd. (Nasdaq:CHTP): A development stage pharmaceutical company, focuses on the acquisition, development and commercialization of pharmaceutical products for the treatment of various human diseases. Market cap is at $233.97M.

14. Arena Pharmaceuticals, Inc. (Nasdaq: ARNA): Focuses on discovering, developing and commercializing oral drugs in the therapeutic areas of cardiovascular, central nervous system, inflammatory and metabolic diseases. Market cap is at $233.11M.

15. Xenoport, Inc. (Nasdaq: XNPT): Focuses on developing and commercializing internally discovered product candidates that utilize the body's natural nutrient transport mechanisms to enhance the therapeutic benefits of drugs. Market cap is at $149.65M.

Use the Investopedia Stock Simulator to trade the stocks mentioned in this stock analysis, risk free!

Kapitall's Danny Guttridge does not own any of the shares mentioned above. RTT News gives more details on the drugs under review.

Related Articles
  1. Mutual Funds & ETFs

    What Exactly Are Arbitrage Mutual Funds?

    Learn about arbitrage funds and how this type of investment generates profits by taking advantage of price differentials between the cash and futures markets.
  2. Investing News

    Ferrari’s IPO: Ready to Roll or Poor Timing?

    Will Ferrari's shares move fast off the line only to sputter later?
  3. Stock Analysis

    5 Cheap Dividend Stocks for a Bear Market

    Here are five stocks that pay safe dividends and should be at least somewhat resilient to a bear market.
  4. Investing

    How to Win More by Losing Less in Today’s Markets

    The further you fall, the harder it is to climb back up. It’s a universal truth that is painfully apparent in the investing world.
  5. Investing

    5 Recession Resistant Industries

    No companies are completely recession proof, but some industries perform better in a weak economy than others.
  6. Fundamental Analysis

    Use Options Data To Predict Stock Market Direction

    Options market trading data can provide important insights about the direction of stocks and the overall market. Here’s how to track it.
  7. Stock Analysis

    2 Oil Stocks to Buy Right Now (PSX,TSO)

    Can these two oil stocks buck the trend?
  8. Investing News

    What Alcoa’s (AA) Breakup Means for Investors

    Alcoa plans to split into two companies. Is this a bullish catalyst for investors?
  9. Economics

    The 4 Countries That Produce the Most Chocolate

    Discover the four countries in the world that manufacture the largest amount of chocolate and learn basic facts about the chocolate industry.
  10. Stock Analysis

    Top 3 Stocks for the Coming Holiday Season

    If you want to buck the bear market trend by going long on consumer stocks, these three might be your best bets.
  1. How do dividends affect retained earnings?

    When a company issues a cash dividend to its shareholders, the retained earnings listed on the balance sheet are reduced ... Read Full Answer >>
  2. What is the difference between called-up share capital and paid-up share capital?

    The difference between called-up share capital and paid-up share capital is investors have already paid in full for paid-up ... Read Full Answer >>
  3. Why would a corporation issue convertible bonds?

    A convertible bond represents a hybrid security that has bond and equity features; this type of bond allows the conversion ... Read Full Answer >>
  4. How does additional paid in capital affect retained earnings?

    Both additional paid-in capital and retained earnings are entries under the shareholders' equity section of a company's balance ... Read Full Answer >>
  5. What types of capital are not considered share capital?

    The money a business uses to fund operations or growth is called capital, and there are a number of capital sources available. ... Read Full Answer >>
  6. What is the difference between issued share capital and subscribed share capital?

    The difference between subscribed share capital and issued share capital is the former relates to the amount of stock for ... Read Full Answer >>

You May Also Like

Trading Center
You are using adblocking software

Want access to all of Investopedia? Add us to your “whitelist”
so you'll never miss a feature!