Experts see allogeneic CAR-Ts as less likely to carry potential risks of T-cell malignancies, and an opportunity for differentiation against the crowded autologous CD19-directed CAR-T space.

CAR-T therapy-associated T-cell malignancies that the US FDA is investigating could make the treatments less attractive in autoimmune diseases than in oncology, but patients in both settings already accept some cancer risk with other available medicines.

Hopes are that the impact of the US FDA’s investigation into a small number of T-cell malignancies associated with CAR-T therapies will be small since the benefit/risk profile still looks sound.

Public Company Edition: Sage will reveal cost reductions later in the third quarter after the US FDA approved zuranolone for the smaller of two depression indications. Also, Karyopharm revealed a 20% workforce reduction, Harmony accessed up to $185m in debt and Astellas invested $50m in Poseida.