FDA rejects Eagle Pharmaceuticals' marketing application for heat stroke med Ryanodex, trading halt to end shortly

Jul. 26, 2017 12:44 PM ETEagle Pharmaceuticals, Inc. (EGRX)By: Douglas W. House, SA News Editor11 Comments
  • Eagle Pharmaceuticals (NASDAQ:EGRX +1.1%) is poised for a down move after it announced that it received a Complete Response Letter (CRL) from the FDA regarding its New Drug Application (NDA) seeking approval for RYANODEX (dantrolene sodium) for the treatment of exertional heat stroke. Trading is set to resume at 1:00 pm ET after being suspended earlier this morning.
  • The CRL cites the need to conduct an additional clinical trial.
  • CEO Scott Tarriff says, “We are reviewing our options and will evaluate the FDA’s response to chart a path forward for RYANODEX for this important indication and life-threatening condition."
  • RYANODEX remains approved for the treatment of malignant hyperthermia and for the prevention of malignant hyperthermia in high-risk patients.
  • Update: down 20% upon resumption of trading.

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