The first quarter of 2026 marked a slower period for regulatory approvals across gene, cell, and RNA therapies, with two new approvals globally — both non-genetically modified cell therapies. Japan granted marketing authorization to Sumitomo’s raguneprocel for Parkinson’s disease and Cuorips’ ReHeart for heart failure, while no additional gene or RNA therapies were approved. Global totals now stand at 40 approved gene therapies (including genetically modified cell therapies), 37 RNA therapies, and 75 non-genetically modified cell therapies.

Despite one fewer approval than in Q4 2025, regulatory momentum remained strong. Accelerated pathways expanded notably, with 13 additional designations granted quarter over quarter. Broad use of Fast Track, RMAT, Breakthrough, and Orphan designations continues to reflect active regulatory engagement and steady pipeline advancement.

Industry activity also remained resilient. Dealmaking rose 3% to 103 transactions, driven by increased financings and alliances and stable acquisition volume. Two major CAR-T acquisitions — Gilead’s $7.8 billion purchase of Arcellx and Eli Lilly’s acquisition of Orna Therapeutics for up to $2.4 billion — underscore continued confidence in the space. Early-stage activity held steady at 13 seed or Series A rounds, though total capital raised declined 30% to $388.4 million.

Overall, Q1 2026 signals a period of strategic recalibration rather than stagnation. While approvals slowed, the marked increase in regulatory designations and steady deal activity point to a field that is actively de-risking and positioning assets for future success. Continued investment, particularly in high-value acquisitions and early-stage innovation, reinforces underlying confidence in the sector’s long-term trajectory. Together, these dynamics suggest that momentum remains intact beneath the surface, with the groundwork being laid for a stronger cadence of approvals and clinical advancement in the quarters ahead.

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