Bris­tol My­ers Squibb and blue­bird bio re­turn to FDA; Take­da gets a break­through nod

More than two months af­ter the FDA slammed Bris­tol My­ers Squibb and blue­bird bio with a suprise refuse-to-file on their  “ide-cell” CAR-T ther­a­py, the pair of de­vel­op­ers have re­sub­mit­ted their ap­pli­ca­tion.

The new ap­pli­ca­tion comes just in time to keep the con­tin­gent val­ue rights from the Cel­gene deal alive. The “ide-cell” was one of the ther­a­pies Bris­tol My­ers picked up in the mon­ster ac­qui­si­tion and one of three ther­a­pies that have to be ap­proved by ear­ly next year to gain every Cel­gene share­hold­er $9. Mizuho an­a­lyst Sal­im Syed es­ti­mat­ed that Bris­tol My­ers would have to re­sub­mit by Ju­ly 31 — to­mor­row — to get an FDA de­ci­sion on time.

Unlock this article instantly by becoming a free subscriber.

You’ll get access to free articles each month, plus you can customize what newsletters get delivered to your inbox each week, including breaking news.

SIGN UP LOG IN BECOME A PREMIUM SUBSCRIBER