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Celgene (CELG) Submits NDA for MS Drug to FDA for Review
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Celgene Corporation announced that it has submitted a New Drug Application (NDA) to the FDA for multiple sclerosis (MS) candidate, ozanimod.
Ozanimod, an oral, sphingosine 1-phosphate (S1P) receptor modulator, is currently being evaluated for the treatment of relapsing forms of multiple sclerosis (RMS).
The NDA contains efficacy and safety data from the SUNBEAM and RADIANCE part B phase III, multicenter, randomized, double-blind, double-dummy, active-controlled studies.
We remind investors that the company suffered a setback early 2018, when it received Refusal to File letter from the FDA regarding its NDA for ozanimod. The FDA stated that the nonclinical and clinical pharmacology sections in the NDA were inadequate to allow a complete review.
Celgene has also submitted its application for review in Europe for the same.
Ozanimod is also being evaluated for ulcerative colitis and Crohn's disease.
Celgene’s stock has lost 0.4% in the past six months compared with the industry’s decline of 18.4%.
A tentative approval will boost Celgene’s portfolio, but competition is stiff in the MS market from the likes of Biogen (BIIB - Free Report) .
Meanwhile, Celgene has been in the news lately due to a merger agreement with Bristol Myers Squibb Company (BMY - Free Report) announced earlier this year. Per the deal, Bristol Myers will acquire Celgene for a whopping $74 billion. Celgene’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 achievement 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 - Free Report) 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.
However, Bristol-Myers Squibb is facing opposition from some of its shareholders, putting the future of the merger with Celgene in jeopardy.
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Celgene (CELG) Submits NDA for MS Drug to FDA for Review
Celgene Corporation announced that it has submitted a New Drug Application (NDA) to the FDA for multiple sclerosis (MS) candidate, ozanimod.
Ozanimod, an oral, sphingosine 1-phosphate (S1P) receptor modulator, is currently being evaluated for the treatment of relapsing forms of multiple sclerosis (RMS).
The NDA contains efficacy and safety data from the SUNBEAM and RADIANCE part B phase III, multicenter, randomized, double-blind, double-dummy, active-controlled studies.
We remind investors that the company suffered a setback early 2018, when it received Refusal to File letter from the FDA regarding its NDA for ozanimod. The FDA stated that the nonclinical and clinical pharmacology sections in the NDA were inadequate to allow a complete review.
Celgene has also submitted its application for review in Europe for the same.
Ozanimod is also being evaluated for ulcerative colitis and Crohn's disease.
Celgene’s stock has lost 0.4% in the past six months compared with the industry’s decline of 18.4%.
A tentative approval will boost Celgene’s portfolio, but competition is stiff in the MS market from the likes of Biogen (BIIB - Free Report) .
Meanwhile, Celgene has been in the news lately due to a merger agreement with Bristol Myers Squibb Company (BMY - Free Report) announced earlier this year. Per the deal, Bristol Myers will acquire Celgene for a whopping $74 billion. Celgene’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 achievement 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 - Free Report) 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.
However, Bristol-Myers Squibb is facing opposition from some of its shareholders, putting the future of the merger with Celgene in jeopardy.
Zacks Rank
Celgene currently carries a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
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