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Cullinan Therapeutics Receives FDA Fast Track Designation for CLN-049 in Relapsed/Refractory AML
ByAinvest
Monday, Dec 1, 2025 10:22 am ET1min read
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.
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