June delivered a landmark for the CAR-T field alongside a distinct shift in US regulatory posture. CARsgen secured NMPA approval for satri-cel, the first CAR-T cell therapy approved for a solid tumor indication anywhere in the world, targeting Claudin18.2 in advanced gastric and gastroesophageal junction adenocarcinoma. In parallel, the US FDA signaled a more accommodating stance on accelerated approval, a shift coinciding with recent changes in agency leadership, as uniQure reversed course on AMT-130 for Huntington’s disease and REGENXBIO cleared a path to resubmit NAVSUNLI for MPS II (Hunter syndrome).
Abigail Pinchbeck· Cell and Gene Therapy Insigh...· 0 citations
July 2026 saw the field push access outward on multiple fronts, from the first FDA approval of a genetic therapy for children as young as 2 years (Vertex’s CASGEVY) to the first international patient treated with satri‑cel, the first CAR‑T therapy approved anywhere for a solid tumor. Regulatory momentum extended across in vivo CAR‑T, allogeneic transplant, and solid tumor cell therapy, while ARPA‑H committed up to $160 million to scalable in vivo gene editing for rare diseases. Alongside these milestones, new partnerships, a €33 million financing, and first patient dosings in pivotal trials for Gaucher disease type 1 and diabetic retinopathy signaled continued investment across the manufacturing, clinical, and commercial landscape.
Abigail Pinchbeck· Cell and Gene Therapy Insigh...· 0 citations
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