|Company Name||Celgene Corporation|
|Class Period||September 12, 2016 to February 27, 2018|
|Lead Plaintiff Motion Deadline||May 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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