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Celgene Corporation

Company NameCelgene Corporation
Stock SymbolCELG
Class PeriodSeptember 12, 2016 to February 27, 2018
Lead Plaintiff Motion DeadlineMay 29, 2018

The complaint filed in this class action alleges that throughout the Class Period, defendants made materially false and misleading statements and/or failed to disclose that: (1) the trials for GED-0301 suffered from fatal design defects, such that GED-0301 had failed to demonstrate meaningful clinical efficacy; (2) as a result, there was an undisclosed risk and high likelihood that Celgene would be unable to develop GED-0301 into a commercially viable treatment for Crohn’s disease; (3) the growth of Otezla sales had dramatically slowed during Celgene’s third fiscal quarter of 2017; and (4) the clinical and nonclinical pharmacology data in Celgene’s new drug application (“NDA”) for Ozanimod were insufficient to permit a complete review by the FDA, which resulted in the FDA issuing a refusal to file letter to Celgene regarding the NDA. 

On February 27, 2018, Celgene announced that the FDA rejected the Company’s New Drug Application (“NDA”) for Ozanimod, a treatment for multiple sclerosis. Celgene stated that it had received a refusal-to-file letter from the FDA, which advised the Company that the FDA had “determined that the nonclinical and clinical pharmacology sections in the NDA were insufficient to permit a complete review.” On this news, Celgene’s share price fell $8.66, or 9%, on February 28, 2018, thereby injuring investors.

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