Bluebird Bio Q2 2022 Earnings Report
Key Takeaways
Bluebird Bio reported significant progress in the second quarter, with unanimous FDA advisory committee support for beti-cel and eli-cel. The company is focused on commercial readiness and anticipates launching both therapies in the fourth quarter of this year. The BLA submission for lovo-cel remains on track for the first quarter of next year.
Beti-cel received unanimous positive vote at FDA Advisory Committee meeting.
Eli-cel received unanimous positive vote at FDA Advisory Committee meeting.
bluebird bio remains on track to submit a BLA to the FDA for lovo-cel for sickle cell disease in the first quarter of 2023.
Ended quarter with $218M in restricted cash, cash and cash equivalents and marketable securities
Bluebird Bio
Bluebird Bio
Forward Guidance
bluebird bio anticipates potential FDA approval of beti-cel and eli-cel and plans for future regulatory submissions.
Positive Outlook
- FDA has set a PDUFA goal date for beti-cel for August 19, 2022
- If approved, the Company anticipates first apheresis in the fourth quarter of 2022 for beti-cel.
- FDA has set a PDUFA goal date of September 16, 2022 for eli-cel.
- If approved, the Company anticipates therapy availability in the fourth quarter of 2022 for eli-cel.
- The Company plans to submit its BLA for lovo-cel in Q1 2023.
Challenges Ahead
- The Company is in active communication with the FDA to resolve the lovo-cel partial clinical hold and resume enrollment and treatment of patients under the age of 18.
- The Company expects to complete vector and drug product analytical comparability in the fourth quarter of 2022.
- Risk that eli-cel and/or beti-cel may not be approved within the priority review timeframe or at all.
- Risk that any one or more of our product candidates, including eli-cel and/or beti-cel, will not be successfully developed, approved or commercialized.
- The Company is in active communication with the FDA to resolve the eli-cel clinical hold and anticipates the FDA’s questions may be resolved concurrent with the agency’s ongoing review of the Company’s BLA submission.