Italfarmaco Presents New Givinostat Data in Duchenne Muscular Dystrophy at ICNMD 2026

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Italfarmaco presented new clinical data on givinostat in Duchenne muscular dystrophy at the 19th International Congress on Neuromuscular Diseases in Florence. Quantitative MRI findings from the Phase 3 EPIDYS trial showed statistically significant differences between givinostat and placebo in muscle composition measures, with contractile cross-sectional area differences ranging from 0.43 to 1.20 square centimeters and fat fraction differences from negative 3.4 percent to negative 4.6 percent across selected lower limb muscles. Interim analyses from the ongoing open-label extension study of 225 patients reported a median age at persistent loss of ambulation of 17.3 years, compared with previously published natural history data of 11.0 to 13.4 years for corticosteroid-treated patients. Long-term safety data with up to more than 10 years of treatment in the extension study were generally consistent with the known safety profile, with no new safety signals.

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Positive clinical data on givinostat in Duchenne muscular dystrophy presented at ICNMD 2026

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