Roivant reports positive Phase 3 uveitis trial results and plans 2027 filing
+1 new source since this summary was written
Roivant Sciences said on October 21, 2026 that brepocitinib met the primary and key secondary goals in both CLARITY Phase 3 studies for non-infectious uveitis. Together, the trials included 371 participants, and brepocitinib extended the median period before treatment failure to more than 48 weeks versus approximately 12 weeks with placebo. Priovant Therapeutics, Roivant's subsidiary, plans to submit a supplemental New Drug Application in the first half of 2027.
Why it matters
The results give Roivant a potential regulatory path for brepocitinib in non-infectious uveitis, subject to the planned filing and regulatory review. The reported efficacy and safety data mechanically strengthen the case for that submission, while the application timing remains in the future.
Key facts
- 1Brepocitinib 45 mg taken once daily showed statistically significant benefit over placebo on the primary and all key secondary endpoints in both CLARITY studies. investing.com
- 2The two trials involved 371 patients in total. investing.com
- 3The median time before treatment failure was greater than 48 weeks for brepocitinib and approximately 12 weeks for placebo in each study. investing.com
- 4Across the CLARITY studies, 62% of brepocitinib patients achieved steroid-free quiescence at Week 48, compared with 20% receiving placebo. investing.com
- 5Among participants who began the studies with macular edema, 42% of eyes treated with brepocitinib had resolved the condition at Week 48, versus 4.8% with placebo. investing.com
- 6Priovant Therapeutics intends to file a supplemental New Drug Application for brepocitinib in the first half of calendar year 2027. investing.com
Open questions
- The materials report different premarket gains for Roivant shares, with one stating 9% and the other 7%; the discrepancy is unresolved.
Summary written by AlphAI AI Desk from 2 of 2 sources. Not investment advice. Figures are as stated by the linked sources.