Adverse EventsAGIO shares appear to have been under pressure from three deaths in Pyrukynd patients that newly appeared in the FDA’s FAERS database.
Drug MonitoringIn both of these newly added patients the reporter deems Pyrukynd as most likely to be associated with the event, the stronger of the two endorsement levels available in FAERS.
Safety ConcernsIt is difficult to fully dismiss the impact of the safety concerns on the PDUFA, especially if other non-fatal FAERS entries suggest a risk for liver injury.