Welcome to our dedicated page for Roivant Sciences news (Ticker: ROIV), a resource for investors and traders seeking the latest updates and insights on Roivant Sciences stock.
Roivant Sciences Ltd. reports developments across a Vant-based biopharmaceutical portfolio, including clinical and regulatory updates from Priovant Therapeutics and other subsidiaries. Recurring coverage centers on brepocitinib, a JAK1/TYK2 inhibitor being developed for autoimmune and inflammatory diseases such as dermatomyositis, non-infectious uveitis, cutaneous sarcoidosis and lichen planopilaris.
Company updates also cover FcRn-targeting antibodies IMVT-1402 and batoclimab, mosliciguat for pulmonary hypertension associated with interstitial lung disease, financial results, share repurchases and technology-related matters involving Genevant’s lipid nanoparticle delivery platform. Roivant news commonly links pipeline progress with subsidiary-level development plans and corporate capital actions.
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.
Roivant (Nasdaq: ROIV) will report second-quarter financial results for the period ended September 30, 2025 and provide a business update on Monday, November 10, 2025. The company will host a live conference call and webcast at 8:00 a.m. ET. Investors can register to access the call by phone and view presentation and webcast details under Events & Presentations on Roivant's investor website. An archived webcast will be available on Roivant's website after the conference call.
Roivant (Nasdaq: ROIV) and Priovant Therapeutics announced breakthrough results from their Phase 3 VALOR study of brepocitinib in treating dermatomyositis (DM). The once-daily oral 30mg dose demonstrated significant superiority over placebo, achieving a week 52 mean Total Improvement Score (TIS) of 46.5 versus 31.2 (p=0.0006).
Key highlights include: 62% of brepocitinib patients reduced steroid use to ≤2.5 mg/day (vs 34% placebo), over two-thirds achieved moderate response (TIS≥40), and nearly half showed major response (TIS≥60). The drug demonstrated rapid onset, with significant improvements visible by week 4. Among patients with moderate-to-severe skin disease, 44% achieved cutaneous clinical remission by week 52 (vs 21% placebo).
The safety profile aligned with previous trials, and Priovant plans an NDA filing in the first half of 2026.