Blue­bird to miss Q1 dead­line for lo­vo-cel fil­ing, shares sliced

Blue­bird bio had ex­pect­ed to sub­mit a BLA for its sick­le cell dis­ease gene ther­a­py lovotibeglo­gene au­totem­cel, or lo­vo-cel, by Fri­day. Now, that dead­line is get­ting punt­ed for at least a cou­ple of weeks.

CEO An­drew Oben­shain de­tailed the up­date dur­ing the com­pa­ny’s full-year earn­ings call Wednes­day morn­ing af­ter the gene ther­a­py spe­cial­ist re­port­ed the de­vel­op­ment in its Q4 and 2022 re­port.

“We will like­ly miss the Q1 2023 sub­mis­sion goal,” Oben­shain said, not­ing the ap­pli­ca­tion is ful­ly writ­ten and ready to go. But blue­bird is still wait­ing on FDA feed­back for the com­pa­ny’s CMC mod­ule sub­mit­ted in ear­ly March.

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