Cullinan Therapeutics Says FDA Granted Fast Track Designation To CLN-049 For Treatment Of Relapsed/Refractory Acute Myeloid Leukemia

Promising efficacy and favorable safety data from the Phase 1 study in heavily pre-treated patients show potential of CLN-049 to address a broad population of AML patients

CAMBRIDGE, Mass., Dec. 01, 2025 (GLOBE NEWSWIRE) -- Cullinan Therapeutics, Inc. (NASDAQ:CGEM), a clinical-stage biopharmaceutical company accelerating potential first- or best-in-class, high-impact therapies in autoimmune diseases and cancer, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to CLN-049 for the treatment of relapsed/refractory (R/R) acute myeloid leukemia (AML). Data from the Phase 1 clinical trial of CLN-049 will be presented at the upcoming 67th American Society of Hematology (ASH) Annual Meeting and Exposition in an oral presentation on December 8.