FDA Orphan Drug Designation for ICT01 as Treatment for AML

“Receiving FDA orphan drug designation for ICT01 is a significant recognition of ICT01’s innovative therapeutic potential to meet the urgent unmet medical needs of AML patients,” said Stephan Braun, MD, PhD, Chief Medical Officer of ImCheck Therapeutics.”This important regulatory milestone reinforces our confidence that ICT01 will become the first immunotherapy for AML patients and supports our goal of rapidly advancing ICT01 into pivotal studies based on the unprecedented results observed in the clinic to date.”

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