Regulators and sponsors continued to reshape development timelines in multiple programs. Regenxbio said the FDA placed a second clinical hold on its Hunter syndrome gene therapy after asymptomatic spine MRI findings in five patients, prompting the company to step back from near-term BLA resubmission expectations. In another safety-driven course change, Chimeric Therapeutics halted its phase I/IIa study of the cadherin-17-targeted autologous CAR T therapy CHM-2101 after dose-limiting toxicities in a second patient at the highest dose level. The company plans to discontinue CHM-2101 and pivot to an early-stage in vivo CAR program targeting the same antigen. Elsewhere, Lundbeck reported it halted a TED study ahead of an anticipated phase III readout for bexicaserin, underscoring the continued reshuffling of endpoints and timelines across late-stage programs.