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.

More BCMA-directed therapies are in development, as well as ones targeting GPRC5D and FcRH5, along with CELMoDs. The question is how to bring those into therapy and pay for them.