2023-04-24 07:55:25 ET
- Bluebird bio ( NASDAQ: BLUE ) added ~5% pre-market Monday after the biotech announced the submission of its Biologics License Application (BLA) for lovo-cel seeking the FDA’s priority review as an ex-vivo gene therapy for sickle cell disease.
- Specifically, the BLA for lovo-cel (lovotibeglogene autotemcel) targets those aged 12 and older with SCD with a history of vaso-occlusive events.
- If granted, the priority review will speed up the review timeline to six months from a standard review period of 10 months from the time of filing.
- Bluebird bio ( BLUE ) backs the marketing application with efficacy data from more than 35 patients in its Phase 1/2 HGB-206 and Phase 3 HGB-210 studies and safety data from 50 patients who received lovo-cel as part of the company’s full clinical program for the candidate.
- Early this month, CRISPR Therapeutics ( CRSP ) and Vertex ( VRTX ) completed the rolling submission of their marketing application for exa-cel, an autologous CRISPR/Cas9 gene-edited therapy targeted at SCD and transfusion-dependent beta-thalassemia.
For further details see:
Bluebird bio seeks FDA priority review for sickle cell disease therapy lovo-cel