Celgene to resubmit ozanimod NDA in 1Q19, updates guidance

Celgene Corp. (NASDAQ:CELG) said in its 1Q18 earnings that it plans to submit regulatory applications to FDA and EMA for relapsing multiple sclerosis candidate ozanimod in 1Q19. The timeline settled uncertainty among analysts whose submission estimates ranged from next half to 2021 (see BioCentury Extra, April 30).

Last week, the company unveiled data showing that a metabolite of ozanimod accounted for the "majority" of the total activity of the product in humans, which could provide insight into a refusal-to-file letter FDA issued for an NDA for the candidate in February. Celgene presented the data at the American Academy of Neurology meeting in Los Angeles (see BioCentury Extra, April 26)...