Eagle 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.
Eagle Pharmaceuticals price target raised to $119 from $94 at Piper Jaffray Piper Jaffray analyst David Amsellem raised his price target for Eagle Pharmaceuticals (EGRX) to $119 after analyzing the company's bendamustine products, which are enhanced forms of Teva's (TEVA) Treanda. Amsellem believes there could be "considerable upside" to his current earnings estimates for Eagle. The company's agreement with Teva provides "almost ironclad downside protection, and leaves ample room for upside," he tells investors in a research note. Further, he sees limited potential for generic entrants on Teva's forms of Treanda for the foreseeable future. Amsellem reiterates an Overweight rating on Eagle Pharmaceuticals.