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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.
Novartis pioneered CAR-Ts for leukemia and lymphoma, and inspired by pioneering physician Georg Schett, it also hopes to be first in the race to revolutionize autoimmune disease treatment with the therapies, and has unveiled the first clinical data for its candidate.
Public Company Edition: PTC sold more of its Evrysdi royalties to Royalty Pharma for $1bn. Abivax gained $235.8m in an IPO and concurrent private placement, while Cerevel grossed $450m and Nuvalent and Ultragenyx raised $300m each in follow-on offerings, but Freeline is reviewing strategic options.
- Gene Therapy, Cell Therapy
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