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 $51 from $37 at Cantor Cantor increased its price target on Eagle (EGRX) after the FDA found that Teva's (TEVA) liquid Treanda drug is incompatible with various commonly used polycarbonate-containing injection devices, while the Treanda that Eagle licensed to Teva does not have this problem. The firm thinks this discrepancy will create a number of benefits for Eagle, and it reiterates a Buy rating on the stock.
Eagle Pharmaceuticals price target increased to $67 from $43 at William Blair William Blair raised its price target on Eagle Pharmaceuticals to $67 from $43 citing its belief that the company can become profitable and have significant cash flow pending the approval of EP-3102. The company added that it view last week's FDA label change for Teva's (TEVA) Treanda as a positive for EP-3102 and that its new price target assumes 2016 launch and "reasonable" penetration for EP-3102.