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Roivant (ROIV) and Immunovant (IMVT) announces topline results from proof-of-concept study of IMVT-1402 in cutaneous Lupus Erythematosus

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IMVT-1402 missed the primary endpoint in a cutaneous lupus erythematosus study despite positive IgG-linked trends, while maintaining favorable safety and keeping other clinical timelines on track.

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Immunovant’s proof-of-concept study of IMVT-1402 in cutaneous lupus erythematosus did not achieve statistical significance on the primary endpoint of Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) percent change from baseline at Week 12. Positive trends were observed on multiple endpoints, with deeper IgG reductions resulting in improved clinical outcomes, but the study did not meet IMVT-1402 demonstrated a favorable safety and tolerability profile, consistent with prior studies All other clinical development timelines remain on track

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