More Bad News: Celgene Reveals Refuse-To-File Letter For Ozanimod In MS
Celgene said the US FDA issued a refuse-to-file letter for ozanimod in multiple sclerosis because "the nonclinical and clinical pharmacology sections in the NDA were insufficient to permit a review." It's yet another big blow for a company whose value has been falling since October.
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In last year’s acquisition, Bristol Myers Squibb agreed to pay Celgene investors another $9 per share based on three approvals, including idecabtagene vicleucel (bb2121) by 30 March 2021.
The US FDA took issue with the CMC portion of the BLA for the BCMA-targeted therapy idecabtagene vicleucel for multiple myeloma. An approval is tied to a $9 CVR for Celgene shareholders.
BMS should find out mid-2020 whether its new MS drug will be approved in the EU.