Regenxbio FDA delay ‘not a needle mover,’ says Leerink

Leerink analyst Mani Foroohar keeps an Outperform rating on Regenxbio (RGNX) after the company announced the FDA extended its review of clemidsogene lanparvovec for mucopolysaccharidosis II to February 8, 2026, from November 9, 2025. The extension follows submission of longer-term data for all patients in the pivotal study at the FDA’s request, the analyst tells investors in a research note. Leerink believes the extension is related as much to the recent turnover at the Center for Biologics Evaluation and Research than it is to specific review issues for Regenxbio. It says the delay is “not a needle mover” and should have a muted impact on the shares.