Cullinan Therapeutics Receives FDA Fast Track Designation for CLN-049 in Relapsed/Refractory AML

Cullinan Therapeutics' CLN-049 has been granted FDA Fast Track Designation for the treatment of relapsed/refractory acute myeloid leukemia (AML). The therapy demonstrated promising efficacy and favorable safety in a Phase 1 study and is being evaluated in two ongoing Phase 1 trials. The FDA's Fast Track Program aims to expedite development and review of therapies for serious conditions with unmet medical need.