Nick Leschly at Endpoints JPM20 (Jeff Rumans)

Blue­bird ex­ecs ex­hale af­ter rul­ing sick­le cell ther­a­py 'very un­like­ly' to have caused AML event. How will FDA re­act?

Gene ther­a­py play­er blue­bird bio ran in­to a big stum­bling block last month when they vol­un­tar­i­ly placed a hold on their sick­le cell pro­gram in the wake of two un­ex­pect­ed se­ri­ous ad­verse events, a move that was short­ly fol­lowed by the FDA mak­ing the hold of­fi­cial.

Now, af­ter con­duct­ing fur­ther analy­ses, blue­bird is con­fi­dent that one of those events was prob­a­bly not caused by the gene ther­a­py, in a sigh of re­lief for a field that’s seen a raft of safe­ty is­sues and scares over the last year.

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.