Pfizer's Duchenne Gene Therapy Trial Put On FDA Hold After Patient Death

In a community letter, Pfizer Inc PFE informed the Parent Project Muscular Dystrophy of the death of a young man in the Phase Ib trial of its mini-dystrophin gene therapy.
The event has triggered a halt in screening and dosing and a clinical hold imposed by the FDA.
Pfizer wrote, "At this time, we do not yet have complete information and are actively working with the trial site investigator to understand what happened."
The Phase 3 study was testing PF-06939926, Pfizer's AAV9 gene therapy candidate, in both ambulatory and non-ambulatory patients.
In January this year, the Company dosed the first participant in the Phase 3 CIFFREO study, which will evaluate the efficacy and safety of investigational gene therapy candidate PF-06939926 in boys with Duchenne muscular dystrophy (DMD).
Price Action: PFE shares are down 3.07% at $59.14 during the market session on the last check Tuesday.