Celgene, Acceleron planning submissions for luspatercept

Celgene Corp. (NASDAQ:CELG) and Acceleron Pharma Inc. (NASDAQ:XLRN) said luspatercept (ACE-536) met the primary endpoint in the Phase III MEDALIST trial to treat myelodysplastic syndrome (MDS). The partners plan to submit regulatory applications in the U.S. and Europe in 1H19 for the product in the indication.

The double-blind, international trial enrolled about 229 patients with chronic anemia due to very low, low or intermediate risk MDS who were ring sideroblast-positive and required frequent red blood cell transfusions. Patients were also refractory to, intolerant of, or ineligible for treatment with an erythropoietin-stimulating agent (ESA)...