FDA is exploring a path forward for therapies that previously received complete response letters (CRLs), according to a report on unusual meetings with FDA’s chief counsel involving Biohaven, Regenxbio, and Sydnexis. The conversations suggest FDA may be formalizing options for re-engagement after major regulatory setbacks. The companies’ exposure to high-profile CRLs puts them in the “second-chance” category that could reshape timelines for resubmission strategies, including additional endpoints, manufacturing updates, or trial design adjustments. For the broader sector, the development is notable because it points to potential procedural clarity for sponsors navigating repeated review failures—often a primary driver of cash burn and program restructuring.