Cullinan Therapeutics, Inc. (CGEM) on Tuesday said the U.S. Food and Drug Administration has granted Orphan Drug Designation to CLN-049 for the treatment of Acute Myeloid Leukemia.
The designation provides certain development incentives, including tax credits for qualified clinical trials, exemption from some FDA user fees and the potential for seven years of U.S. market exclusivity following approval.
CLN-049 is a novel, investigational FLT3xCD3 T cell engager designed to target FLT3-expressing leukemia cells, offering a new immunotherapeutic approach for treating acute myeloid leukemia and myelodysplastic syndrome.
Cullinan shares were up more than 2% in pre-market trading after closing at $14.87 on Monday.
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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.