** charts after earnings **
Bluebirdbio also provides eli-cel safety update
- The company received a reported Suspected Unexpected Serious Adverse Reaction (SUSAR) ofmyelodysplastic syndrome (MDS), that is likely mediated by Lenti-D lentiviral vector (LVV)insertion, in a patient who was treated with eli-cel, or Lenti-D drug product for CALD over oneyear ago in the Phase 3 ALD-104 study. Evidence currently available suggests that specificdesign features of Lenti-D LVV likely contributed to this event. The company has shared thisinformation with the independent data monitoring committee of the study and the FDA hasplaced the eli-cel program on a clinical hold.
- The company does not anticipate the clinical hold to impact its programs in sickle cell disease(SCD), -thalassemia or oncology. Subject to resolution of the clinical hold, the companyanticipates completing the submission of the rolling BLA for eli-cel in 2021.
Bluebirdbio misses by $0.32, misses on revs
- Reports Q2 (Jun) loss of $3.58 per share, $0.32 worse than the S&P Capital IQ Consensus of($3.26); revenues fell 96.2% year/year to $7.5 mln vs the $13.31 mln S&P Capital IQConsensus.
- Cash, cash equivalents and marketable securities as of June 30, 2021 and December 31, 2020were $941.6 million and $1.27 billion, respectively.
- On track to complete planned business separation in 4Q21; each company launching withapproximately 24 months of runway following separation.
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