Roivant: Priovant's brepocitinib meets primary endpoint in two Phase 3 uveitis trials
Roivant and its subsidiary Priovant reported that brepocitinib 45 mg met the primary endpoint and all key secondary endpoints in the two identical Phase 3 CLARITY-1 and CLARITY-2 trials in non-infectious uveitis, with 371 patients enrolled. Priovant plans to file a supplemental New Drug Application for NIU in the first half of calendar 2027, which would be the next step toward a possible new treatment for the condition. The filing furnishes the press release under Regulation FD and contains no financial results.
Key points
- Primary endpoint (time to treatment failure) met in CLARITY-1 (N=166) and CLARITY-2 (N=204); 371 patients enrolled in total
- Median time to treatment failure was greater than 48 weeks in both studies, versus about 12 weeks on placebo (p<0.0001 in both)
- Pooled, 62% of brepocitinib patients achieved steroid-free quiescence at Week 48, versus 20% on placebo
- Priovant intends to file the sNDA in the first half of calendar 2027; Roivant investor call set for 8:00 a.m. ET on October 21, 2026
The filing
Written by AI (Anthropic Claude, claude-haiku-5-5) on Nov 7, 2026, 11:17 PM ET, from the text of the filing and its press-release exhibits only.
Briefs are written by AI from the filing text (each brief's own page names the model) and can contain mistakes — open the filing before acting on anything. Impact (1-5) and tone are the model's reading of the filing for shareholders, not a price forecast. Not investment advice.