Bluebird Bio Q3 Loss Narrows; Adjusts LentiGlobin BLA Submission Timing To Late 2022

(RTTNews) - bluebird bio Inc. (BLUE) reported that its third-quarter net loss narrowed to $194.75 million or $2.94 per share from $206.03 million or $3.73 per share last year. Analysts polled by Thomson Reuters expected the company to report a loss of $3.01 per share for the third-quarter. Analysts' estimates typically exclude special items. The company has adjusted LentiGlobin's biologic license application submission timing to late 2022.

Total revenues for the quarter rose to $19.27 million from $8.91 million in the prior year. Analysts expected revenue of $24.16 million for the quarter.

The company said it plans to complete the biologics license application submission to the U.S. FDA for LentiGlobin for sickle cell disease in 2022.

The company said it is on track to complete a rolling BLA submission to the U.S. FDA for beti-cel in mid-2021. The submission will include all patients with transfusion dependent ß-thalassemia across all genotypes including non-ß0/ß0 genotypes and ß0/ß0 genotypes.

The FDA has set a Prescription Drug User Fee Act or PDUFA goal date of March 27, 2021 for the approval of ide-cel (bb2121) in patients with relapsed and refractory multiple myeloma.

The company plans to present bb21217 clinical data from the ongoing CRB-402 study in patients with multiple myeloma by the end of 2020. It also plans to present ide-cel clinical data from the ongoing CRB-401 study in patients with multiple myeloma by the end of 2020, in partnership with BMS.

The company plans to present updated data from the ongoing HGB-206 clinical study in patients with sickle cell disease by the end of 2020.

BLUE closed Wednesday regular trading at $58.55 up $5.46 or 10.28 percent. But in the after-hours trading, the stock dropped $7.05 or 12.04 percent.