Refusal-to-file letter for BMS-bluebird cell therapy further muddies chances of Celgene payout

Partners BMS and bluebird are insistent that FDA’s refusal-to-file letter for their BCMA-targeting cell therapy is merely the result of a documentation issue that isn’t representative of any larger problem. But the resulting delay, which is likely to add about four months to the programs’ timeline to market, may open up space for other BCMA therapeutic developers to establish themselves, with GSK and partners J&J and Legend standing to benefit the most.

The slowdown of the therapy’s review could also further jeopardize the fulfillment of a multibillion dollar payout to Celgene’s shareholders tied to BMS’s takeout of that company last year...