Sentences with phrase «ozanimod demonstrated»

Ozanimod demonstrated a significant reduction in new or enlarging T2 lesions over one year for 1 mg (48 percent, p < 0.0001) and 0.5 mg (25 percent, p = 0.0032) compared with IFN.

Not exact matches

In particular, the complaint alleges that throughout the Class Period, defendants made materially false and / or 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) the growth of Otezla sales had dramatically slowed during Celgene's third fiscal quarter of 2017; and (3) 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.

A significant reduction in gadolinium - enhanced MRI lesions at 1 year was also demonstrated for ozanimod 1 mg (63 percent, p < 0.0001) and ozanimod 0.5 mg (34 percent, p = 0.0182) compared with IFN.