(RTTNews) - Cullinan Therapeutics (CGEM) announced that the FDA has granted Fast Track designation to CLN-049 for the treatment of relapsed/refractory acute myeloid leukemia. The company said data from the Phase 1 clinical trial of CLN-049 will be presented at the upcoming 67th American Society of Hematology Annual Meeting and Exposition in an oral presentation on December 8.
Jeffrey Jones, Chief Medical Officer, Cullinan Therapeutics, said: "This regulatory milestone provides important momentum for development, and we look forward to collaborating closely with the FDA to rapidly advance CLN-049 for patients who desperately need more effective therapies."
Shares of Cullinan Therapeutics are up 2% in pre-market trade on Monday.
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