Beam's base-edit­ed al­lo­gene­ic CAR-T gets FDA go-ahead af­ter four-month wait

The FDA want­ed more in­for­ma­tion on four key ar­eas be­fore it would let Beam Ther­a­peu­tics pro­ceed with hu­man test­ing for a cell ther­a­py in a cer­tain type of leukemia. It ap­pears the biotech has an­swered the agency’s queries.

The US reg­u­la­tor cleared the base-edit­ed, off-the-shelf CAR-T, Beam said Fri­day morn­ing, lift­ing a hold from this sum­mer. More de­tails on spe­cif­ic next steps for the Phase I will come out next year, the Boston-area biotech said.

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