Market PressureAGIO shares appear to have been under pressure from three deaths in Pyrukynd patients that newly appeared in the FDA’s FAERS database.
Patient SafetyTwo of the recent deaths were in young patients, specifically 28 and 26 years old, which raises concerns due to their age.
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.