David Chang, Allogene CEO (Jeff Rumans)

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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