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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May 15, 2026 15:25 ET Apart from the confirmation of Kevin Warsh as the next Fed chair, the main news on the economics front this week included key price data from the U.S. and the first quarter economic growth figures from major economies. Both consumer prices and producer costs have started to reflect the effect of supply shocks due to the Middle East conflict. In Europe, GDP data was in focus, while inflation data from China dominated the news flow in Asia.