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Biotech Stocks Facing FDA Decision In August

Pfizer
Pfizer

The FDA decision on Pfizer’s (PFE) Besponsa as monotherapy for the treatment of adults with relapsed or refractory CD22-positive B-cell precursor acute lymphoblastic leukemia is expected to be announced in August. No specific date has been announced.

Besponsa is under priority review by the FDA.

In a phase III trial, although the improvement in overall survival with Besponsa was not statistically significant compared to chemotherapy, the risk of progression or death was reduced by 55% with Besponsa versus standard therapy.

Besponsa was associated with a complete response (CR) or CR with incomplete platelet recovery (CRi) rate of 80.7% versus 29.4% with chemotherapy in the study.

The drug was approved in the European Union as recently as June 30, 2017.

PFE closed Friday's (July 28) trading at $33.15, up 0.45%.