09:26 AM EDT, 08/04/2025 (MT Newswires) -- CASI Pharmaceuticals ( CASI ) said Monday the US Food and Drug Administration has cleared its investigational new drug application for CID-103, a potential treatment for adults with active and chronic active renal allograft antibody mediated rejection.

The phase 1 trial will assess the tolerability and efficacy of CID-103 in patients with disease, the company said.

AMR is a leading cause of kidney transplant loss, leading to dialysis and/or repeat renal transplant, the company said.

CASI Pharmaceuticals' ( CASI ) shares were more than 20% higher in premarket trading.