Allogene wins a major reprieve for its leading off-the-shelf cell therapy pipeline
Allogene is rolling into JP Morgan week with a big win for its development campaign for off-the-shelf CAR-Ts. Late last week the FDA agreed to lift the regulatory blockade that had been dropped on their full set of clinical trials after evidence of chromosomal changes in one of the patients triggered a safety alert.
In an advance of the announcement Monday morning, Allogene $ALLO CEO David Chang said in an interview that the company worked through the last 3 months with regulators to zero in on the exact trigger of the chromosomal mutations. Regulators, he said, agreed that the drug wasn’t involved and released the clinical hold.
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