Calluna secures FDA orphan drug designation for CAL101 in IPF
CAL101 is intended for the treatment of idiopathic pulmonary fibrosis (IPF). It is currently studied in the Phase II AURORA trial, with patient recruitment underway in the US,
Leukogene Therapeutics has received orphan drug designation (ODD) from the US Food and Drug Administration (FDA) for M2T-CD33 (LTI-214), its immunotherapy candidate targeting acute myeloid leukaemia (AML).