The second quarter of 2026 marked a renewed acceleration in regulatory activity across the gene, cell, and RNA therapy landscape, with eight new approvals globally following a comparatively subdued first quarter. Five gene therapies received marketing authorization, including treatments for hearing loss, cancer, and limb ischemia. Moderna's mCombriax became the latest approved RNA therapy in the European Union for seasonal influenza and COVID-19, while Japan authorized two non-genetically modified cell therapies for epidermolysis bullosa and meniscal injuries. Together, these approvals reflect continued diversification across therapeutic modalities and indications, bringing global totals to 46 approved gene therapies (including genetically modified cell therapies), 37 RNA therapies, and 76 non-genetically modified cell therapies.

Innovation also accelerated during the quarter, with 11 new mRNA-encoded CAR-T cell therapies entering development, matching the total reported across all of 2025. This rapid expansion signals growing confidence in next-generation engineering approaches designed to improve the scalability and accessibility of cell therapies. Cartesian Therapeutics' Phase III candidate, Descartes-08, remains the most advanced program in this emerging modality.

Industry activity strengthened alongside scientific progress. Total dealmaking increased 15% quarter over quarter to 118 transactions—the highest quarterly total in the past year—while early-stage financing rebounded sharply, with 20 companies raising a combined $500.4 million in seed or Series A funding. Following the disciplined portfolio optimization observed in late 2025 and the steady regulatory progress seen in Q1, Q2 suggests the field has regained momentum across regulatory, scientific, and investment fronts, reinforcing continued confidence in the long-term growth of advanced molecular therapies.

For the full report, please download the PDF version at the top of this page in collaboration with ASGCT.