[Ad hoc announcement pursuant to Art. 53 LR] Roche provides

From GlobeNewswire: 2025-06-15 01:00:00

Roche has announced new dosing restrictions for Elevidys in non-ambulatory Duchenne muscular dystrophy patients after two cases of fatal acute liver failure. Dosing for non-ambulatory patients has been paused in clinical settings and discontinued in commercial settings. The benefit-risk profile for Elevidys in ambulatory patients remains positive. This decision comes after reassessment following the fatal cases. Duchenne muscular dystrophy is a rare genetic disease that primarily affects males and causes muscle-wasting. Roche is working with health authorities to ensure patient safety and care. The temporary clinical holds on Elevidys studies are still in effect.



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