Celgene Corporation CELG announced that it has submitted a Marketing Authorization Application to the European Medicines Agency (EMA) for pipeline candidate, ozanimod.
The company is seeking approval of ozanimod, an oral, sphingosine 1-phosphate (S1P) receptor modulator, for the treatment of adults with relapsing-remitting multiple sclerosis (RRMS).
The application was based on results from the SUNBEAM and RADIANCE part B phase III, multicenter, randomized, double-blind, double-dummy, active-controlled studies.
Celgene intends to submit a New Drug Application (NDA) to the FDA for relapsing forms of MS (RMS) by the end of this month.
We remind investors that Celgene 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.
Ozanimod is also being evaluated for ulcerative colitis and Crohn's disease.
Celgene’s stock has lost 1.8% in the past six months compared with the industry’s decline of 13%.
A tentative approval will boost Celgene’s portfolio but competition is stiff in the MS market with the likes of Biogen BIIB.
Meanwhile, Celgene has been in news lately due to a merger agreement with Bristol Myers Squibb Company BMY announced earlier in 2019. The latter will acquire the former for a whopping $74 billion. Per the terms, 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 all three products (ozanimod, liso-cel and bb2121) within specified time periods.
Earlier, Celgene and partner bluebird bio BLUE completed enrollment in the KarMMa pivotal trial, evaluating bb2121 in patients with relapsed and/or refractory multiple myeloma (RRMM).
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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