A risky bet on a long-de­layed CAR-T drug now faces a do-or-die dead­line — where any slip can kill a $9 CVR

The dead­line for an FDA ap­proval of Bris­tol My­ers’ CAR-T drug liso-cel is go­ing right down to the wire.

The phar­ma gi­ant put out the word to­day that the FDA is tak­ing an ex­tra 3 months to com­plete its re­view af­ter the com­pa­ny pro­vid­ed an­oth­er batch of in­fo on the drug at the FDA’s re­quest — which reg­u­la­tors deemed a ma­jor amend­ment.

That moves the goal line on a de­ci­sion to No­vem­ber 16, just 6 weeks or so be­fore the end-of-year dead­line Bris­tol My­ers es­tab­lished for Cel­gene in­vestors as one of 3 pos­i­tive mar­ket­ing de­ci­sions that have to be won to get a $9 con­tin­gent val­ue right, or CVR, {BMY.RT} pay­off in their $74 bil­lion merg­er.

Endpoints News

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.