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Mar 31, 2021
Bluebird Bio Q1 2021 Earnings Report
Reported first quarter financial results and highlighted operational progress.
Key Takeaways
Bluebird Bio reported its Q1 2021 financial results, featuring the FDA approval of Abecma and progress in resolving safety events in their sickle cell disease program. The company is also advancing its planned business separation, targeted for completion by year-end 2021.
Abecma received FDA approval as the first CAR T therapy for relapsed or refractory multiple myeloma.
Investigation of AML case in HGB-206 study determined it was highly unlikely to be due to BB305 lentiviral vector.
Revised diagnosis of MDS case in Phase 1/2 study of LentiGlobin for SCD to transfusion-dependent anemia.
Business separation into bluebird bio and 2seventy bio is targeted for completion by year-end 2021.
Bluebird Bio
Bluebird Bio
Forward Guidance
Bluebird bio anticipates several milestones in the near future, including regulatory submissions and clinical data updates.
Positive Outlook
- SCD: The company is investigating the recently-reported safety events and plans to continue to work closely with the FDA in their review of these events to provide an update on the Company’s development plan and timeline for submission for regulatory approval by year end.
- TDT: The company is on track to complete its rolling BLA submission to the U.S. FDA for beti-cel in mid-2021, contingent upon successful resolution of any U.S. FDA concerns applicable to the program arising out of the recently-reported safety events in the SCD program.
- CALD: The company is on track to complete its BLA submission to the U.S. FDA for eli-cel in mid-2021. The company plans to receive European approval for eli-cel in patients with CALD in mid-2021.
- Updated data from ongoing clinical study in patients with SCD by the end of 2021.
- bluebird bio anticipates the separation of its severe genetic disease and oncology businesses into two independent, publicly traded companies (bluebird bio and 2seventy bio) to be completed by the end of 2021.
Challenges Ahead
- The company is investigating the recently-reported safety events and plans to continue to work closely with the FDA in their review of these events to provide an update on the Company’s development plan and timeline for submission for regulatory approval by year end.
- TDT: The company is on track to complete its rolling BLA submission to the U.S. FDA for beti-cel in mid-2021, contingent upon successful resolution of any U.S. FDA concerns applicable to the program arising out of the recently-reported safety events in the SCD program.
- bluebird bio anticipates the separation of its severe genetic disease and oncology businesses into two independent, publicly traded companies (bluebird bio and 2seventy bio) to be completed by the end of 2021.
- The company is investigating the recently-reported safety events and plans to continue to work closely with the FDA in their review of these events to provide an update on the Company’s development plan and timeline for submission for regulatory approval by year end.
- TDT: The company is on track to complete its rolling BLA submission to the U.S. FDA for beti-cel in mid-2021, contingent upon successful resolution of any U.S. FDA concerns applicable to the program arising out of the recently-reported safety events in the SCD program.