$ROIV · Roivant Sciences Ltd.
Roivant and subsidiary Priovant Therapeutics announced positive topline results from the Phase 3 CLARITY program (CLARITY-1 and CLARITY-2) evaluating brepocitinib 45 mg in non-infectious uveitis. Both identical trials met the primary endpoint of time to treatment failure with hazard ratios of 0.27 and 0.22 (both p<0.0001), and all key secondary endpoints including steroid-free quiescence, macular edema resolution, and visual functioning were statistically significant. Priovant intends to file an sNDA in H1 2027.
- Median time to treatment failure for brepocitinib exceeded 48 weeks vs. ~12 weeks on placebo in both CLARITY-1 and CLARITY-2 (p<0.0001).
- Pooled steroid-free quiescence at Week 48: 62% on brepocitinib vs. 20% on placebo (p<0.0001).
- Macular edema resolution at Week 48 (pooled): 42% of eyes on brepocitinib vs. 4.8% on placebo (p<0.0001).
- Hazard ratio for treatment failure: 0.27 in CLARITY-1 and 0.22 in CLARITY-2, both highly statistically significant.
- Only 3% of participants discontinued due to adverse events; no new safety signals observed.
Extended-hours trading shows ROIV at $38.50, up 10.25% from the regular close of $34.92, reflecting strong investor enthusiasm for the clean sweep on primary and all key secondary endpoints.
Brepocitinib's magnitude of benefit across every ranked endpoint, combined with a more aggressive steroid taper than precedent trials, suggests it could become the dominant systemic non-steroid NIU
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Brepocitinib's results set a new efficacy bar in NIU, where no new systemic non-steroid therapy has launched in nearly a decade. The data positions Roivant to build a rare-disease immunology franchise alongside recently launched LISRAYA for dermatomyositis.
The sNDA submission is planned for H1 2027, meaning regulatory approval and commercial launch are still 12-18 months away; the NIU market is estimated at 70,000–190,000 U.S. adults, a relatively niche indication.
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