BMY - Bristol-Myers Squibb withdraws sBLA for Reblozyl in non-transfusion beta thalassemia

Bristol-Myers Squibb (NYSE:BMY) has withdrawn a supplemental Biologics License Application for Reblozyl (luspatercept) for anemia with non-transfusion dependent beta thalassemia. The pharma said it was doing so as it could not address questions posed by the U.S. FDA on the risk-benefit profile of the biologic based on phase 2 data. Reblozyl is approved for transfusion-dependent anemia-associated beta thalassemia. Earlier Friday, Bristol (BMY) said it was buying precision oncology biotech Turning Point Therapeutics (TPTX) for more than $4B.

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Bristol-Myers Squibb withdraws sBLA for Reblozyl in non-transfusion beta thalassemia