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Here's Why Eagle Pharmaceuticals Fell 7%

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Shares of Eagle Pharmaceuticals Inc (NASDAQ: EGRX), a specialty pharmaceutical company that focuses on orphan diseases and oncology areas, fell more than 7 percent on Monday.

Eagle Pharmaceuticals announced earlier in the day that the U.S. Food and Drug Administration denied the company's request for seven years of orphan drug exclusivity in the U.S. for its BENDEKA product.

BENDEKA was approved by the FDA in December 2015 for the treatment of patients with indolent B-cell non-Hodgkin lymphoma. An orphan drug designation would have granted Eagle Pharmaceuticals with a seven-year period of U.S. marketing exclusivity, as well as certain financial incentives that can help support its development.

Eagle Pharmaceuticals added in its press release that it believes the FDA's decision is "incorrect" as the drug was "automatically entitled to orphan drug exclusivity for CLL and indolent B-cell NHL upon the drug's December 2015 approval." The company added it is "evaluating all options" to challenge the FDA's decision.

 

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