Pharma BD Deal Intelligence
Roivant and Pfizer formed Priovant Therapeutics in September 2021, with Pfizer licensing global development rights and US/Japan commercial rights to brepocitinib (an oral and topical TYK2/JAK1 inhibitor) into the new "Vant" in exchange for a 25% equity stake. The JV launched with registrational programs in dermatomyositis (DM) and systemic lupus erythematosus (SLE). The two programs diverged sharply: in November 2023 the Phase 2 SLE study missed its primary endpoint (SRI-4 at week 52) against an unusually high placebo response, and Priovant discontinued brepocitinib in SLE. The DM program, by contrast, delivered the first-ever positive 52-week placebo-controlled Phase 3 in dermatomyositis (VALOR, positive topline December 2024; 241 subjects, week-52 mean TIS 46.5 vs 31.2 placebo, p=0.0006). In March 2026 the FDA accepted the brepocitinib NDA in DM and granted Priority Review, with a PDUFA target in Q3 2026 and a planned US launch at end of September 2026 — positioning brepocitinib as the potential first targeted therapy for dermatomyositis. Priovant has since expanded brepocitinib into non-infectious uveitis (Phase 3), cutaneous sarcoidosis (positive Phase 2; Phase 3 in 2026) and lichen planopilaris (Phase 2/3).