The FDA signaled renewed flexibility for uniQure’s Huntington’s disease gene therapy. After earlier concerns about acceptable evidence, the regulator agreed that three-year analysis data from uniQure’s Phase 1/2 program are acceptable to support an accelerated BLA filing—expected in the third quarter—according to uniQure. Separately, media coverage indicates another FDA reversal on uniQure’s program, reinforcing that policy posture around accelerated pathways may be shifting. The decisions matter because Huntington’s gene therapy is a high-profile test case for how much early-stage evidence can substitute for additional trials during review. For the sector, the uniQure outcome could affect how other sponsors plan endpoints, statistical analysis windows, and confirmatory study designs when pursuing accelerated approval routes.