Trials of bluebird's LentiGlobin now on FDA hold

The US Food and Drug Administration (FDA) has placed bluebird bio’s (Nasdaq: BLUE) Phase I/II and Phase III studies of LentiGlobin gene therapy for sickle cell disease (SCD) on a clinical hold.

This action from the FDA comes after the US biotech voluntarily suspended the studies temporarily following a reported suspected unexpected serious adverse reaction (SUSAR) of acute myeloid leukemia (AML), news that sent bluebird's share price to drop 38% lower in a single day last week.

In line with the clinical study protocols for the trial, bluebird bio had placed the studies on temporary suspension following a report received earlier this month that a patient who was treated more than five years ago in the Phase I/II study was diagnosed with AML.