- Celgene (NASDAQ:CELG) and Acceleron (XLRN) announce that Luspatercept achieved primary and key secondary endpoints in Phase III MEDALIST study for low-to-intermediate-risk myelodysplastic syndromes.
- Primary endpoint was red blood cell transfusion independence of at least 8 consecutive weeks during the first 24 weeks compared to placebo.
- Secondary endpoints: Improvement in RBC transfusion independence of at least 12 consecutive weeks during the first 24 was the key endpoint. Modified hematologic improvement-erythroid was a meaningful secondary endpoint.
- Data from the trial will be submitted to a “future medical meeting in 2018.”
- The companies plan to submit regulatory applications in the US and Europe in 1H19.
- Celgene shares are up 0.7% aftermarket to $77.17.
- Acceleron Pharma shares are up 3% to $34.99.