FDA Refuses to File Celgene Application for MS Candidate Ozanimod

Celgene has acknowledged that the FDA sent the company a “Refuse to File” letter in response to its New Drug Application (NDA) for the relapsing multiple sclerosis (MS) candidate ozanimod—the biotech’s second setback to one of its later-stage drug candidates in recent months.Ozanimod is a novel, oral, selective sphingosine 1-phosphate 1 (S1PR1) and 5 (S1PR5) receptor modulator being developed for relapsing MS as well as ulcerative colitis and Crohn's disease. Celgene has