Celgene & Acceleron Submit BLA for Luspatercept to the FDA

Celgene Corporation CELG announced that it has submitted a Biologics License Application (BLA) for pipeline candidate, luspatercept, a first-in-class erythroid maturation agent (EMA) that regulates late-stage red blood cell (RBC) maturation.

The company is developing luspatercept in collaboration with partner Acceleron Pharma Inc. XLRN.

The BLA is seeking FDA approval of luspatercept for the treatment of adult patients with very low to intermediate risk myelodysplastic syndromes (MDS)-associated anemia, who have ring sideroblasts and require RBC transfusions, and adult patients with beta-thalassemia-associated anemia, who require RBC transfusions.

The BLA was submitted on the basis of safety and efficacy results from the phase III studies, MEDALIST and BELIEVE.

Both the companies plan to submit a marketing application to the European Medicines Agency in the second quarter of 2019.

Meanwhile, the candidate is also being evaluated in phase III trial, COMMANDS, for the treatment of erythropoiesis-stimulating agent (ESA) naïve, lower-risk MDS patients. Luspatercept is also being evaluated in the BEYOND phase II trial in non-transfusion-dependent beta-thalassemia, and a phase II trial in myelofibrosis.

Celgene’s stock has gained 9.3% in the past six months, against the industry’s decline of 6.2%.

 

Meanwhile, the company has been in the news lately due to a merger agreement with Bristol-Myers Squibb Company BMY announced earlier this year. Per the deal, Bristol-Myers will acquire Celgene for a whopping $74 billion. The company’s shareholders will receive $50 plus one share of Bristol-Myers and one tradeable Contingent Value Right (CVR), which will entitle the holder to receive a cash payment of $9.00 upon the receipt of FDA approval of three products in its pipeline — ozanimod, liso-cel and bb2121 — within specified time periods.

The company also has a co-development and co-promotion agreement with bluebird bio, Inc. BLUE for bb2121, an experimental anti-B-cell maturation antigen (BCMA) chimeric antigen receptor (CAR) T cell therapy, for the potential treatment of patients with relapsed/refractory multiple myeloma in the United States. The acquisition of Juno Therapeutics has added liso-cel to Celgene’s lymphoma pipeline.

Zacks Rank

Celgene currently carries a Zacks Rank #3 (Hold). You can see  the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

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