Sharp Increase in FDA Drug Approvals a Major Factor in Biotech Industry's Success in 2012
RDInvesting Provides Stocks Research on ADVENTRX Pharmaceuticals and Corcept Therapeutics
NEW YORK, NY -- (Marketwire) -- 02/28/13 -- A sharp increase in drug approvals and mergers and acquisitions combined to create a bull market for the Biotechnology Industry in 2012. The iShares NASDAQ Biotechnology Index (IBB), the SPDR S&P Biotech ETF (XBI) and the First Trust Amex Biotechnology Index ETF (FBT) have all gained over 20 percent in the past year, outperforming the broader markets by a good margin. Research Driven Investing examines investing opportunities in the Biotech Industry and provides equity research on ADVENTRX Pharmaceuticals, Inc. (NYSE: ANX) and Corcept Therapeutics Inc. (NASDAQ: CORT).
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Bloomberg recently reported drug approvals by the U.S. Food and Drug Administration reached a 15 year high in 2012. The FDA approved a total of 39 novel medicines last year, an increase of 30 percent when compared to a year ago. Oncology drugs lead the way with 11 new drugs approved last year. Over the last ten years the number of FDA approvals had averaged roughly 23 a year. The passage of the Prescription Drug User Fee Act (PDUFA) played a major role in the sharp increase in approvals.
The PDUFA "has provided critical resources for improving the quality and timeliness of premarket review of drugs," said FDA spokeswoman Sandy Walsh. "These accomplishments could not have been achieved without the innovations of the biopharmaceutical industry and the dedication and skill of FDA's drug review staff."
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ADVENTRX Pharmaceuticals' lead product candidate, ANX-188, is an investigational agent that has potential to reduce ischemic tissue injury and end-organ damage by restoring microvascular function, which is compromised in a wide range of serious and life-threatening diseases and conditions. The company recently announced that they have reviewed data that supports development of ANX-188 in multiple indications, including those outside of sickle cell disease.
Corcept Therapeutics is a pharmaceutical company engaged in the discovery, development and commercialization of drugs for the treatment of severe metabolic and psychiatric disorders. Korlym is approved by the FDA for the treatment of endogenous Cushing's syndrome. The company reported estimated revenues of $1.4 million for the fourth quarter of 2012.
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