Brepocitinib Hits Both Phase 3 Uveitis Trials, Cutting Treatment Failure Risk ~75%
ROIV has more than doubled off its 52-week low of $17.28.
Summary
Brepocitinib met the primary endpoint in both Phase 3 NIU studies, with hazard ratios for treatment failure of 0.27 (CLARITY-1) and 0.22 (CLARITY-2) versus placebo, both P<0.0001. Roughly 59-64% of treated patients achieved steroid-free quiescence in both eyes at Week 48 versus about 19% on placebo, and all key secondary endpoints, including macular edema resolution and visual functioning, were statistically significant despite a faster steroid taper than prior NIU trials. Safety was consistent with the known profile and only 3% discontinued for adverse events. Priovant plans an sNDA in the first half of 2027, which would make NIU the second commercial pillar after LISRAYA's August dermatomyositis approval. This is the cleanest clinical win in the recent run, following the September IMVT-1402 cutaneous lupus miss and the positive mosliciguat Phase 2 in PH-ILD. An investor call is set for 8:00 a.m. ET today, and an investor day is scheduled for December 9, 2026.
At the time of this announcement, ROIV was trading at $36.60 on NASDAQ in the Life Sciences sector, with a market capitalization of approximately $25.2B. The 52-week trading range was $17.28 to $42.50. This news item was assessed with positive market sentiment and an importance score of 9 out of 10. Source: GlobeNewswire.