FDA Decisions: Biotech Companies Waiting For FDA Approval

FDA Decisions: Biotech Companies Waiting For FDA Approval

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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. (STAY AHEAD OF THE CURVE: Follow Kapitall on Twitter)

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 a big revenue increases.

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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?

 

Interactive Chart: Use the Compar-O-Matic to compare market caps for the stocks mentioned below:

List sorted by market cap.

 

 

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

 

 

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

 

 

“3. Gilead Sciences Inc. (GILD, Earnings, Analysts, Financials): 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 (VRTX, Earnings, Analysts, Financials): 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. (SLXP, Earnings, Analysts, Financials): Develops, and commercializes prescription drugs for the treatment of gastrointestinal disorders in the United States. Market cap at $3.11B.

 

“6. VIVUS Inc. (VVUS, Earnings, Analysts, Financials): 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. (CTIC, Earnings, Analysts, Financials): Engages in the development, acquisition, and commercialization of drugs for the treatment of cancer. Market cap at $1.08B.

 

 

“8. ProtalixBioTherapeutics, Inc. (PLX, Earnings, Analysts, Financials): 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. (MAPP, Earnings, Analysts, Financials): Focuses on the development and commercialization of inhalation therapies for patients suffering from migraine. Market cap at $476.72M.

 

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

 

 

“11. Progenics Pharmaceuticals Inc. (PGNX, Earnings, Analysts, Financials): 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 at $329.16M.

 

 

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

 

 

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

 

 

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

 

“15. Xenoport, Inc. (XNPT, Earnings, Analysts, Financials): 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 at $149.65M.

 

 

(Written by Danny Guttridge. RTT News gives more details on the drugs under review.)

 

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