Celgene slips on ozanimod speculation

Amid a broad decline in biotech indexes Monday, Celgene Corp. (NASDAQ:CELG) dropped $4.08 (4%) to $87.10 as speculation around the timeline for multiple sclerosis candidate ozanimod heats up ahead of the bellwether's first quarter earnings release Friday.

Last week, Celgene unveiled data showing that a metabolite of ozanimod accounted for the "majority" of the total activity of the relapsing multiple sclerosis candidate in humans, which could provide insight into a refusal-to-file letter FDA issued for an NDA for the candidate in February. In guidance published in 2016, FDA addressed human metabolites that could cause a safety concern and noted the “discovery of disproportionate drug metabolites late in drug development can potentially cause development and marketing delays." Celgene presented the data at the American Academy of Neurology meeting in Los Angeles (see BioCentury Extra, April 26)...