Competitive Efficacy RiskFailure of FT819 to show a clear efficacy advantage versus other allogeneic or autologous CAR-T approaches could limit adoption and pressure valuation.
Durability ConcernsMixed durability signals, such as rapid B-cell recovery in some regimens and at least one patient relapse about one year after dosing, create uncertainty around sustained benefit in lupus.
Safety, Immunogenicity And Execution RisksPotential unexpected safety or immunogenicity issues, plus partnership execution or regulatory setbacks, could delay trials or restrict future approval prospects.