Celgene Corporation CELG and Acceleron Pharma Inc. XLRN announced top-line results from a phase III, multi-center study (MEDALIST). The MEDALIST study evaluated the efficacy and safety of luspatercept versus placebo in patients with very low, low or intermediate risk myelodysplastic syndromes (MDS) with chronic anemia and refractory to, intolerant of, or ineligible for treatment with an erythropoietin-stimulating agent (ESA), ring sideroblast-positive and require frequent red blood cells (RBC) transfusions.
The study showed that luspatercept achieved a highly statistically significant improvement in the primary endpoint of red blood cell (RBC) 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 RBC transfusion independence of at least 12 consecutive weeks during the first 24 weeks. The study also achieved modified hematologic improvement-erythroid (IWG mHI-E), a meaningful secondary endpoint.
Data from MEDALIST will be submitted to a future medical meeting in 2018. Based on these results, the company expects to file for submissions and regulatory submissions are planned in the United States and Europe in the first half of 2019. If approved the candidate can be a boost to the company’s revenues. Both the companies also plan to evaluate luspatercept in ESA-naïve, low-to-intermediate risk MDS patients in the phase III COMMANDS study.
Year to date, shares of Celgene declined 26.5% compared with the industry’s decline of 9%.
Zacks Rank & Stock to Consider
Celgene carries a Zacks Rank #3 (Hold).
Some better-ranked stocks from the same space are Aeglea BioTherapeutics, Inc. AGLE and ANI Pharmaceuticals, Inc. ANIP. Both Aeglea and ANI Pharmaceuticals carry a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Aeglea’s loss per share estimates have narrowed from $1.93 to $1.67 for 2018 and from $3.86 to $3.57 for 2019 over the past 60 days. The company delivered a positive earnings surprise in three of the trailing four quarters with an average beat of 19.32%. The stock has rallied 93.5% so far this year.
ANI Pharmaceuticals’ earnings per share estimates have moved up from $5.54 to $5.70 for 2018 and from $5.72 to $6.15 for 2019 over the past 60 days. The company delivered a positive earnings surprise in three of the trailing four quarters with an average beat of 8.69%. The stock has rallied 4.7% so far this year.
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