Quantcast

Celgene & Acceleron Submit BLA for Luspatercept to the FDA


Shutterstock photo

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 .

Is Your Investment Advisor Fumbling Your Financial Future?

See how you can more effectively safeguard your retirement with a new Special Report, "4 Warning Signs Your Investment Advisor Might Be Sabotaging Your Financial Future."

Click to get it free >>


Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report

Bristol-Myers Squibb Company (BMY): Free Stock Analysis Report

Acceleron Pharma Inc. (XLRN): Free Stock Analysis Report

bluebird bio, Inc. (BLUE): Free Stock Analysis Report

Celgene Corporation (CELG): Free Stock Analysis Report

To read this article on Zacks.com click here.

Zacks Investment Research

The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.





This article appears in: Investing , Business , Stocks
Referenced Symbols: BMY , XLRN , BLUE , CELG



More from Zacks.com

Subscribe







Zacks.com
Contributor:

Zacks.com

Equity Research












Research Brokers before you trade

Want to trade FX?