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Roivant Sciences (ROIV) investor relations material
Roivant Sciences Study result summary
Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.Trial design
CLARITY-1 and CLARITY-2 were identical Phase 3 trials enrolling 371 adults with active, non-anterior NIU; participants received brepocitinib 45 mg once daily or placebo for 48 weeks.
The primary endpoint was time to treatment failure from Week 6 to Week 48; oral corticosteroids started at 60 mg, then tapered to zero by Week 8.
Primary efficacy
Both trials met the primary endpoint; median time to treatment failure exceeded 48 weeks with brepocitinib versus 13 weeks in CLARITY-1 and 12 weeks in CLARITY-2 (HR 0.27 and 0.22; p<0.0001 in both).
Pooled Week 48 treatment failure was 33.5% with brepocitinib versus 78.2% with placebo; among prior-TNFi patients, rates were 38.1% versus 77.5%.
Secondary outcomes
Pooled Week 48 steroid-free quiescence was 62% with brepocitinib versus 20% with placebo; results were consistent across subgroups.
Pooled macular edema resolution was 42% with brepocitinib versus 4.8% with placebo; FA response and VFQ-25 response also improved, and all key secondary endpoints were statistically significant in both trials.
- Strong clinical progress and commercial focus drive expansion in autoimmune and orphan indications.ROIV
Bank of America Global Healthcare Conference - FDA approval, best-in-class PH-ILD data, and robust pipeline drive strong outlook.ROIV
Citigroup’s Biopharma Back to School Summit 2026 - Mosliciguat's breakthrough data and brepocitinib's promising DM launch drive major pipeline momentum.ROIV
12th Annual Cantor Fitzgerald Global Healthcare Conference - PHocus trial data in PH-ILD and LISRAYA's launch highlight major advances and pipeline momentum.ROIV
Wells Fargo 21st Annual Healthcare Conference - Mosliciguat delivered record PVR reduction, functional gains, and strong safety in PH-ILD.ROIV
Study result - FDA approved LISRAYA as the first targeted oral therapy for dermatomyositis, launching immediately.ROIV
FDA announcement - $950M Moderna payment, $3.9B cash, and key product launch set for September 2026.ROIV
Q1 2027 - Proxy covers director elections, auditor ratification, say-on-pay, and highlights governance and ESG.ROIV
Proxy filing - Key votes include director elections, auditor ratification, and executive pay approval.ROIV
Proxy filing
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