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Stock Market & Financial Investment News

News Breaks
March 20, 2014
08:02 EDTEGRXEagle Pharmaceuticals says FDA acceptsa NDA for Ryanodex
Eagle Pharmaceuticals announced that the United States Food and Drug Administration has accepted the company’s New Drug Application for Ryanodex and granted a priority review classification. The PDUFA date is July 22. In January 2014, Eagle filed its NDA with the FDA for the treatment of malignant hyperthermia. In February 2014, the FDA conditionally accepted Eagle’s trade name Ryanodex. Ryanodex has previously been granted Orphan Drug designation and Eagle currently owns three U.S. patents covering the product. Eagle intends to commercialize Ryanodex after approval and will retain exclusive marketing rights in the U.S.
News For EGRX From The Last 14 Days
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February 23, 2015
10:26 EDTEGRXEagle Pharmaceuticals granted seven years of market exclusivity to Ryanodex
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February 18, 2015
07:45 EDTEGRXEagle Pharmaceuticals price target raised to $37 from $30 at Cantor
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07:13 EDTEGRXEagle Pharmaceuticals target raised to $43 from $25 at William Blair
William Blair raised its price target for Eagle Pharmaceuticals (EGRX) to $43 saying the company's agreement with Teva (TEVA) removes a major overhang on the stock. William Blair says the deal is a significant positive for Eagle since it removes litigation risk and moves the company immediately into profitability. It keeps an Outperform rating on the stock.
February 17, 2015
16:07 EDTEGRXEagle Pharmaceuticals reports Q4 EPS (39c), consensus (49c)
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08:39 EDTEGRXTeva deal small but important, says BMO Capital
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07:04 EDTEGRXTeva, Eagle enter license agreement for EP-3102
Teva Pharmaceutical Industries (TEVA) and Eagle Pharmaceuticals (EGRX) announce that the companies have entered into an exclusive license agreement for EP-3102, Eagle’s bendamustine hydrochloride rapid infusion product for the treatment of chronic lymphocytic leukemia and indolent B-cell non-Hodgkin lymphoma. Teva will be responsible for all U.S. commercial activities for the product including promotion and distribution. Eagle has responsibility for obtaining all regulatory approvals, conducting post-approval clinical studies, if required, and initially supplying drug product to Teva. As part of the agreement, Teva will waive its orphan drug exclusivities for NHL and CLL with respect to EP-3102, which should allow the product to come to market more quickly. Under the terms of the exclusive license agreement, Eagle will receive an upfront cash payment of $30M and is eligible to receive up to $90M in additional milestone payments. In addition, Eagle will receive double-digit royalties on net sales of the product, assuming FDA approval. The companies will also settle the pending patent infringement action between them.

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