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RGNX Regenxbio News Story

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Regenxbio tumbles as FDA halts rare‑disease gene therapy trials after tumor case

** Shares of therapy developer Regenxbio RGNX.O fall 34% to $8.82 premarket

** Co says FDA paused studies of its experimental treatments for two rare childhood disorders

** The two disorders are Hurler syndrome and Hunter syndrome, conditions that cause severe physical and cognitive decline, per co

** Co says a brain tumor was found in a child who received RGX‑111 four years earlier

** Early tests linked therapy DNA near a cancer‑related gene, but causality is unclear, says co

** Co says no similar cases seen in other children treated with RGX‑111 or RGX‑121

** RGX‑111 and RGX‑121 are experimental gene therapies that co is developing for two rare childhood genetic disorders

** Shares up ~86% in 2025

 (Reporting by Sahil Pandey in Bengaluru)

 ((Sahil.Pandey@thomsonreuters.com))

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