Cogent gains FDA Breakthrough Therapy status for bezuclastinib

4 hours ago 1

The US FDA has granted Breakthrough Therapy designation for Cogent Biosciences' bezuclastinib for NonAdvanced Systemic Mastocytosis and Smoldering Systemic Mastocytosis.
The company plans an NDA submission for the first indication by the end of the year.
Breakthrough Therapy status was