Acceleron Pharma Inc. (NASDAQ: XLRN) and Celgene Corp. (NASDAQ: CELG) each saw gains on Friday after they reported results from a late-stage trial. Ultimately the Phase 3 clinical study (MEDALIST) of luspatercept achieved a highly statistically significant improvement in the primary endpoint of red blood cell transfusion independence of at least eight consecutive weeks during the first 24 weeks compared to placebo.
Luspatercept also met the key secondary endpoint of demonstrating a highly statistically significant improvement in red blood cell transfusion independence of at least 12 consecutive weeks during the first 24 weeks. Modified hematologic improvement-erythroid, a meaningful secondary endpoint, was also achieved.
The study evaluated the efficacy and safety of luspatercept versus placebo in patients with IPSS-R very low, low or intermediate risk myelodysplastic syndromes (MDS) with chronic anemia.
The companies plan to submit regulatory applications in the United States and Europe in the first half of 2019.
Jay Backstrom, M.D., chief medical officer for Celgene, commented:
This result from the phase III MEDALIST trial demonstrates the potential clinical benefit of luspatercept as an erythroid maturation agent for the treatment of chronic anemia in patients with low-to-intermediate risk MDS. Based on these results, we look forward to preparing the dossier for global regulatory submissions and also investigating the clinical potential of luspatercept in ESA-naïve, low-to-intermediate risk MDS patients through the initiation of our phase III COMMANDS study.
Shares of Acceleron were last seen up about 40% at $47.52, with a consensus analyst price target of $54.08 and a 52-week trading range of $29.57 to $48.85.
Celgene traded up 4% at $79.94 a share, with a consensus price target of $112.70 and a 52-week range of $74.13 to $147.17.