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Celgene & Acceleron Get FDA Nod for Rare Blood Disorder Drug
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Celgene Corporation and partner Acceleron Pharma Inc. announced that the FDA has approved pipeline candidate Reblozyl (luspatercept-aamt) for the treatment of anemia in adult patients with beta thalassemia, who require regular red blood cell (RBC) transfusions.
Per the company, Reblozyl is the first and only FDA-approved erythroid maturation agent, representing a new class of therapy for these patients. The approval comes ahead of the target action date of Dec 4.
The approval of Reblozyl for beta thalassemia was based on encouraging results from the pivotal, phase III, randomized, double-blind, placebo-controlled, multicenter BELIEVE study. The study evaluated the safety and efficacy of the drug for the treatment of anemia in adult patients with beta thalassemia, who require regular RBC transfusions. The study achieved a clinically meaningful and statistically significant improvement in the primary endpoint.
The approval comes as a significant boost for Celgene, given the dearth of options for patients living with anemia due to beta thalassemia, who are dependent on long-term RBC transfusions.
Meanwhile, the FDA is also evaluating luspatercept-aamt for the treatment of anemia in adults with very low- to intermediate-risk myelodysplastic syndromes (MDS), who have ring sideroblasts and require RBC transfusions. The agency has set a target action date of April 4, 2020, for the same. Celgene’s Marketing Authorization Application for the treatment of anemia in adults with beta thalassemia is currently under review in Europe.
Additionally, a phase II study (BEYOND) in adult patients with non-transfusion-dependent beta thalassemia, a phase III study (COMMANDS) in ESA-naïve, lower-risk MDS patients and a phase II study in myelofibrosis patients are ongoing.
Shares of Celgene have soared 70.9% so far this year compared with the industry's growth of 1.6%. Shares of Acceleron were up 6.6% on the news of the approval.
Celgene has been in news since the beginning of 2019 for its impending merger with Bristol-Myers Squibb Company (BMY - Free Report) . The transaction is expected to close by the end of the year.
Vertex’s earnings estimates have increased to $4.81 from $4.59 in the past 30 days.
5 Stocks Set to Double
Each was hand-picked by a Zacks expert as the #1 favorite stock to gain +100% or more in 2020. Each comes from a different sector and has unique qualities and catalysts that could fuel exceptional growth.
Most of the stocks in this report are flying under Wall Street radar, which provides a great opportunity to get in on the ground floor.
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Celgene & Acceleron Get FDA Nod for Rare Blood Disorder Drug
Celgene Corporation and partner Acceleron Pharma Inc. announced that the FDA has approved pipeline candidate Reblozyl (luspatercept-aamt) for the treatment of anemia in adult patients with beta thalassemia, who require regular red blood cell (RBC) transfusions.
Per the company, Reblozyl is the first and only FDA-approved erythroid maturation agent, representing a new class of therapy for these patients. The approval comes ahead of the target action date of Dec 4.
The approval of Reblozyl for beta thalassemia was based on encouraging results from the pivotal, phase III, randomized, double-blind, placebo-controlled, multicenter BELIEVE study. The study evaluated the safety and efficacy of the drug for the treatment of anemia in adult patients with beta thalassemia, who require regular RBC transfusions. The study achieved a clinically meaningful and statistically significant improvement in the primary endpoint.
The approval comes as a significant boost for Celgene, given the dearth of options for patients living with anemia due to beta thalassemia, who are dependent on long-term RBC transfusions.
Meanwhile, the FDA is also evaluating luspatercept-aamt for the treatment of anemia in adults with very low- to intermediate-risk myelodysplastic syndromes (MDS), who have ring sideroblasts and require RBC transfusions. The agency has set a target action date of April 4, 2020, for the same. Celgene’s Marketing Authorization Application for the treatment of anemia in adults with beta thalassemia is currently under review in Europe.
Additionally, a phase II study (BEYOND) in adult patients with non-transfusion-dependent beta thalassemia, a phase III study (COMMANDS) in ESA-naïve, lower-risk MDS patients and a phase II study in myelofibrosis patients are ongoing.
Shares of Celgene have soared 70.9% so far this year compared with the industry's growth of 1.6%. Shares of Acceleron were up 6.6% on the news of the approval.
Celgene has been in news since the beginning of 2019 for its impending merger with Bristol-Myers Squibb Company (BMY - Free Report) . The transaction is expected to close by the end of the year.
Zacks Rank & Another Key Pick
Celgene currently carries a Zacks Rank #2 (Buy).
Another top-ranked stock in the biotech space is Vertex Pharmaceuticals Inc. (VRTX - Free Report) , which currently carries a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Vertex’s earnings estimates have increased to $4.81 from $4.59 in the past 30 days.
5 Stocks Set to Double
Each was hand-picked by a Zacks expert as the #1 favorite stock to gain +100% or more in 2020. Each comes from a different sector and has unique qualities and catalysts that could fuel exceptional growth.
Most of the stocks in this report are flying under Wall Street radar, which provides a great opportunity to get in on the ground floor.
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