Priovant (NASDAQ: ROIV) launched a seamless Phase 2b/3 trial of brepocitinib in lichen planopilaris (LPP), enrolling its first subjects in March 2026. LPP affects ~100,000 US adults and lacks FDA-approved treatments. Brepocitinib is already in late-stage development for dermatomyositis, non-infectious uveitis, and cutaneous sarcoidosis.
The FDA granted Priority Review to the DM NDA with a PDUFA target action date in Q3 2026; topline NIU data and a CS Phase 3 start are expected in H2 2026. Brepocitinib is a dual JAK1/TYK2 inhibitor.
Roivant (Nasdaq: ROIV) announced a new seamless Phase 2b/3 trial of brepocitinib in lichen planopilaris (LPP), enrolling first subjects in March 2026, and reported topline Phase 3 results for batoclimab in thyroid eye disease (TED) that failed to meet primary endpoints.
FDA Priority Review and a Q3 2026 PDUFA date were assigned to brepocitinib's NDA in dermatomyositis; additional Phase 3 milestones for related programs are expected H2 2026.
Priovant Therapeutics (NASDAQ:ROIV) announced publication in the New England Journal of Medicine of positive Phase 3 VALOR results for brepocitinib 30 mg in dermatomyositis. VALOR enrolled 241 patients, met the primary endpoint with a 15.3-point TIS improvement versus placebo at Week 52 (P<0.001), and showed benefits across nine key secondary endpoints. The FDA granted Priority Review with a PDUFA target action date in Q3 2026. Safety signals included increased serious infections with brepocitinib 30 mg; many events resolved and most patients completed treatment.
Roivant (Nasdaq: ROIV) announced Genevant and Arbutus reached a $2.25 billion global settlement with Moderna on March 3, 2026. Moderna will pay $950 million upfront in July 2026 and up to $1.3 billion contingent on a favorable Section 1498 appellate outcome.
The settlement includes entry of judgment of infringement and no invalidity for four patents, a global non-exclusive LNP license to Moderna for infectious-disease SM-102 mRNA vaccines, and ends related litigation with Moderna. Roivant approved a $1 billion share repurchase program.
Priovant Therapeutics (NASDAQ:ROIV) announced FDA acceptance of its NDA for brepocitinib in dermatomyositis with Priority Review and a PDUFA target action date in Q3 2026. The company expects a U.S. launch at the end of September 2026 if approved.
Priority Review was supported by positive Phase 3 VALOR results (N=241), described as the first positive 52-week placebo-controlled trial in dermatomyositis; approval would represent the first targeted therapy for the disease.
Priovant (Nasdaq: ROIV) announced positive Phase 2 BEACON results for brepocitinib in cutaneous sarcoidosis (CS), showing clinically meaningful and statistically significant benefit versus placebo at Week 16.
Key results: brepocitinib 45 mg achieved a -22.3 mean CSAMI-A change (∆21.6 vs placebo; P<0.0001), 100% ≥10-point CSAMI-A responses, 62% functional remission (CSAMI-A<5), and 69% IGA two-point improvements. No SAEs; AEs mild/moderate. Priovant plans Phase 3 initiation in 2026 following FDA engagement.
Roivant (Nasdaq: ROIV) reported positive Phase 2 results for brepocitinib in cutaneous sarcoidosis (CS) and Q3 fiscal results for the period ended December 31, 2025. Brepocitinib 45 mg achieved a mean CSAMI-A improvement of 22.3 points vs. 0.7 placebo (Δ21.6; P<0.0001) at Week 16, with 100% achieving ≥10-point improvement and 62% reaching remission. The company submitted an NDA for brepocitinib in dermatomyositis, plans a Phase 3 in CS in 2026, and reported consolidated cash and marketable securities of $4.5 billion.
Roivant (Nasdaq: ROIV) will host a live conference call and webcast at 8:00 a.m. ET on Friday, February 6, 2026 to report financial results for the third quarter ended December 31, 2025 and provide a business update.
Investors can register for phone access online and view the presentation and live webcast under Events & Presentations in the Investors section at https://investor.roivant.com/news-events/events. An archived webcast will be available on Roivant’s website after the call.
Roivant (Nasdaq: ROIV) outlined accelerated late‑stage timelines and commercialization plans at its 2025 Investor Day, forecasting 3+ launches, 4+ NDA/BLA filings, 8+ pivotal and 3+ proof‑of‑concept readouts over the next three years.
Key updates: brepocitinib NDA for dermatomyositis expected in early 2026 with launch planned early 2027; brepocitinib topline data for non‑infectious uveitis now expected H2 2026; cutaneous sarcoidosis PoC topline H1 2026; IMVT‑1402 D2T RA topline data expected in 2026. Roivant‑led Immunovant financing raised ~$550 million, extending Immunovant cash runway to IMVT‑1402 launch. Ongoing litigation schedules include a US Moderna jury trial in March 2026.
Roivant (Nasdaq: ROIV) reported Q2 results for the period ended September 30, 2025 and provided a business update.
Clinical highlights: Brepocitinib 30 mg met the primary endpoint and all nine key secondaries in Phase 3 VALOR for dermatomyositis with NDA planned in H1 2026; Phase 3 non-infectious uveitis and PoC cutaneous sarcoidosis trials remain on track for readouts in H1 2027 and H2 2026, respectively. Immunovant reported potentially disease-modifying six-month off-treatment remission data in uncontrolled Graves’ disease; batoclimab TED readouts to be shared concurrently in H1 2026.
Financials: Consolidated cash and marketable securities ~$4.4B; R&D expense $164.6M; loss from continuing operations $166.0M for the quarter.