Samit Hirawat (Bristol Myers Squibb)

Af­ter bruis­ing re­jec­tion, blue­bird and Bris­tol My­ers Squibb land ide-cel pri­or­i­ty re­view. But will it mat­ter for the CVR?

With the clock all but up, the FDA ac­cept­ed and hand­ed pri­or­i­ty re­view to Bris­tol My­ers Squibb and blue­bird bio’s BC­MA CAR-T, keep­ing a nar­row win­dow open for Cel­gene in­vestors to still cash in on the $9 CVR from the $63 bil­lion Cel­gene merg­er.

The ac­cep­tance comes five months af­ter the two com­pa­nies weres slammed with a sur­prise refuse-to-file that threat­ened to fore­close the CVR en­tire­ly. To­day’s ac­cep­tance sets the FDA de­ci­sion date for March 27, 2021 – or pre­cise­ly 4 days be­fore the CVR dead­line of March 31. Giv­en the break­through des­ig­na­tion and strong piv­otal da­ta — 81.5% re­sponse rate, 35.2% com­plete re­sponse rate — pri­or­i­ty re­view was large­ly ex­pect­ed.

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.