Eagle Pharmaceuticals (EGRX) Tops Q2 EPS by 9c; Approves $75M Stock Buyback Plan

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Go back to Eagle Pharmaceuticals (EGRX) Tops Q2 EPS by 9c; Approves $75M Stock Buyback Plan

Eagle Pharmaceuticals (EGRX) Announces Positive Results from Ryanodex NDA Meeting w/ FDA

August 9, 2016 6:46 AM EDT

Eagle Pharmaceuticals (Nasdaq: EGRX) announced that the U.S. Food and Drug Administration ("FDA") has determined that no additional human safety and efficacy data is required for the submission of Eagles New Drug Application (NDA) for Ryanodex® for the treatment of exertional heat stroke (EHS), an investigational new indication for the product, further confirming that a hybrid development program comprised of clinical data from EHS patients and preclinical data from animal studies constitutes an adequate regulatory pathway for the NDA submission.

Eagle has also reduced its future Ryanodex royalty obligations to its licensing... More