Eight new therapies were approved globally in Q2 2026 across three categories. Five gene therapies received approval, one RNA therapy was approved, and two cell therapies were approved in Japan.
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Q2 2026 Gene, Cell + RNA Therapy Landscape Report
The Q2 2026 report reveals that globally, for clinical use, 46 gene therapies have been approved (including genetically modified cell therapies), 37 RNA therapies have been approved, and 76 non-genetically modified cell therapies have been approved. Read the report online, or download the PDF to keep a copy for later.
Q2 2026 Gene, Cell + RNA Therapy Landscape Report
FAQ
How many therapies were approved in Q2 2026, and which categories do they cover?
What does the overall therapy pipeline look like as of Q2 2026?
There are 4,487 therapies currently in development (from preclinical through pre-registration). Gene therapies make up the largest share at 49% (2,217 therapies), followed by non-genetically modified cell therapies at 21% (940 therapies), with RNA therapies accounting for the remainder (1,370 therapies). CAR-T cell therapies dominate the genetically modified cell therapy pipeline, representing 66% of that category — with 81% of CAR-T therapies targeting cancer. Rare diseases and oncology remain the top areas of development across all three categories.
What is the significance of mRNA-engineered CAR-T cell therapies in Q2 2026?
Q2 2026 saw a notable acceleration in non-genetically modified, mRNA-engineered CAR-T therapies. During the quarter 11 new therapies across 12 companies entered the pipeline — matching the entire total from all of 2025.
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