FDA Grants Orphan Drug Designation to M2T-CD33 (LTI-214) for the Treatment of AML
“We are honored that the FDA has recognized the therapeutic promise of LTI-214 by granting Orphan Drug Designation,” said Dr. Sandeep Gupta, CEO of Leukogene. “AML remains one of the most challenging hematologic cancers, and outcomes for relapsed or refractory patients remain poor. The LTI-214 program embodies our commitment to advancing new immunotherapy approaches that are both potent and safer for patients. This designation represents an important step toward our goal of transforming the treatment paradigm for AML.”
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