Curis Gets FDA Orphan Drug Designation For CA-4948 For Treatment Of AML And MDS

Curis Inc. (CRIS) said Monday that it has received Orphan Drug designation from the U.S. Food and Drug Administration for CA-4948, a first-in-class, small molecule inhibitor of IRAK4 and Curis's most advanced therapeutic in clinical development.

CA-4948 targets IRAK4-L, the oncogenic isoform of IRAK4 preferentially expressed by the majority of patients with acute myeloid leukemia or AML and myelodysplastic syndromes (MDS) and has shown broad clinical activity in Phase 1 trials in patients with relapsed or refractory (R/R) AML/MDS.

Orphan Drug Designation is granted by the FDA to drugs intended to treat rare disorders that affect fewer than 200,000 people in the U.S.

For comments and feedback contact: editorial@rttnews.com

Business News

Editors Pick
After Disney World, retail giant Walmart Inc. (WMT) makes it mandatory for all its employees to wear mask on their facilities in the "high-risk" states where the Delta variant of Coronavirus has become menacing. The orders will be in effect immediately. The Center for Disease Control and Prevention... Generac Power Systems is recalling 325,735 units of Generac and DR 6500 Watt and 8000 Watt portable generators for potential risk of finger amputation and crushing hazards, a statement by the U.S. Consumer Product Safety Commission (CPSC) showed. These include 4,575 units sold in Canada. Omaha, Nebraska- based Greater Omaha Packing is recalling around 295,236 pounds of raw beef products citing the possible presence of E. coli O157:H7, the U.S. Department of Agriculture's Food Safety and Inspection Service or FSIS said. The raw beef products intended for non-intact use were produced on July 13.
Follow RTT