Why Are Legend Biotech Shares Gaining Today?

Legend Biotech Corporation's LEGN collaborating partner Janssen Pharmaceutical has submitted a marketing application to the Japanese Ministry of Health, Labour and Welfare (MHLW) seeking approval for ciltacabtagene autoleucel (cilta-cel).
Cilta-cel is a B-cell maturation antigen (BCMA)-directed chimeric antigen receptor (CAR)-T cell therapy for relapsed or refractory multiple myeloma who have received at least three prior therapies.
The submission is based on results from the Phase 1b/2 CARTITUDE-1 study.
Cilta-cel is currently under regulatory review by several health authorities worldwide, including the U.S. and Europe.
In November, the FDA extended the Prescription Drug User Fee Act (PDUFA) target date for cilta-cel to February 28, 2022.
Price Action: LEGN shares are up 10.80% at $49.85 during the market session on the last check Tuesday.