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BCMA, CAR-T, CD19

May 12, 2020

Liso-Cel PDUFA 3-Month Delay; BMS Q1 2020 Call Summary

Here is a brief preview of this blast: On Thursday, May 6, BMS held their Q1 2020 earnings call (press release / slides), providing an update on their CAR-T program. As announced on May 5 (press release), the company explained that the liso-cel PDUFA date has been pushed back three months to November 16, 2020 to allow the FDA time to review additional data considered to be a major amendment. Meanwhile, BMS provided brief commentary on their BCMA CAR-Ts ide-cel and orva-cel. Below, FENIX provides highlights and analysis from the call, particularly in the context of the liso-cel PDUFA setback in a field being led by Yescarta and Kymriah.