It acquired Receptos last year for $ 7.2 billion, gaining hold of promising experimental multiple sclerosis and ulcerative colitis
drug ozanimod in the process.
Celgene signaled high hopes for its experimental multiple sclerosis
drug ozanimod, with key data imminent.
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.
Morgan Stanley said it expects a delay of up to three years for Celgene's key multiple sclerosis
drug,
ozanimod.
That market, however, could become more challenging if competing
drugs, including Celgene's
ozanimod, shine in late - stage studies.
Celgene Corporation (NASDAQ: CELG) shares plummeted 10 percent Tuesday evening after the U.S. Food and
Drug Administration rejected its New
Drug Application for
ozanimod in the treatment of relapsing multiple sclerosis.
Celgene Corporation (NASDAQ: CELG) is under continued stock pressure Wednesday after the U.S. Food and
Drug Administration rejected its New
Drug Application for
ozanimod in the treatment of relapsing multiple sclerosis.
The findings from the two pivotal phase 3 (SUNBEAM and RADIANCE Part B) trials pave the way for
ozanimod to enter the New
Drug Approval process with the U.S. Food and
Drug Administration (FDA).