EMA Orphan Drug Designation for ICT01 as Treatment for AML
“Securing orphan drug designation from both the EMA and the FDA in close succession is a major regulatory milestone for ImCheck,”said Pierre d’Epenoux, Chief Executive Officer of ImCheck Therapeutics.“It reflects growing international recognition of ICT01’s potential and supports our objective to accelerate clinical development in both the U.S. and Europe. The EMA ODD’s broad market exclusivity for ICT01 once approved provides additional value as we consider our development strategy.”
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