BMS Gets US Approval Of Ozanimod For Relapsing MS, But Launch Delayed

It’s one down and two to go both for Bristol-Myers Squibb Co. and for shareholders in the former Celgene Corp. as ozanimod obtained US Food and Drug Administration approval for relapsing multiple sclerosis on 26 March, about two years after the FDA issued a “refuse-to-file” letter for the drug citing insufficient clinical and non-clinical pharmacology data in the new drug application.

Ozanimod, to be branded Zeposia, was cited as one of three primary Celgene pipeline assets driving last year’s $74bn buyout, and Celgene’s shareholders can realize a $9-per-share contingent value right if it and a pair of T-cell therapies for cancer – JCAR017 and bb2121 – all obtain FDA approval before the end of March 2021