FDA Grants Cullinan Orphan Drug Designation For CLN-049 In Treating Leukemia

India, May 19 -- Cullinan Therapeutics Inc. (CGEM), a clinical-stage biopharmaceutical company, on Tuesday announced that the U.S. Food and Drug Administration had granted CLN-049 an Orphan Drug designation in the treatment of acute myeloid leukemia.

Acute myeloid leukemia (AML) is a rare form of blood cancer that is diagnosed in about 4 out of 100,000 people in a standard population.

CLN-049 is a novel, investigational, FLT3xCD3 T-cell engager, currently being evaluated in a Phase 1 open-label, multi-center, first-in-human, multiple ascending dose study for the treatment of relapsed/refractory AML.

The drug is also being assessed for the treatment of myelodysplastic syndrome (MDS).CGEM is currently trading at $13.77, down 7.40%.

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