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FDA decision on Bristol Myers cell therapy could come down to the wire

September 22, 2020

Celgene gained rights to ide-cel through a 2018 deal with Bluebird bio, the experimental therapy’s original developer. When Bristol-Myers made its bid to buy Celgene, the two sides couldn’t agree to the long-term value of ide-cel, the now-approved multiple sclerosis drug Zeposia and another cell therapy called liso-cel.

In order to finalize the deal, the two sides agreed that if Zeposia and liso-cel gained approval by Dec. 31, 2020, and ide-cel by March 31, 2021, Bristol-Myers would pay out another $9 a share through an offer called a “contingent value right,” or CVR. Hitting those marks appeared likely until the FDA rejected Bristol-Myers’ application for ide-cel before review, citing a need for documentation on manufacturing processes.

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