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. (Nasdaq: ROIV) generates a steady flow of news as a biopharmaceutical company focused on developing and commercializing medicines for autoimmune, inflammatory and cardiopulmonary diseases. Company updates frequently center on its late-stage clinical pipeline, including brepocitinib, IMVT-1402, batoclimab and mosliciguat, as well as developments at its subsidiaries Priovant Therapeutics, Immunovant, Pulmovant and Genevant.
Investors following ROIV news can expect detailed coverage of clinical milestones, such as Phase 3 and Phase 2 trial readouts, proof-of-concept data and regulatory filing plans. Recent communications have highlighted positive Phase 3 VALOR results for brepocitinib in dermatomyositis, rapid enrollment in non-infectious uveitis and cutaneous sarcoidosis studies, and six-month off-treatment remission data in Graves’ disease from Immunovant’s batoclimab program. Roivant also issues news about potentially registrational trials for IMVT-1402 across several autoimmune indications and ongoing development of mosliciguat in pulmonary hypertension associated with interstitial lung disease.
Roivant’s news flow also includes quarterly and annual financial results, updates on research and development and general and administrative expenses, and information on capital allocation decisions such as common share repurchase programs. In addition, Genevant-related news may cover progress in lipid nanoparticle intellectual property litigation involving companies such as Moderna and Pfizer/BioNTech, as described in Roivant’s public updates.
This ROIV news page brings together press releases, clinical updates, financial disclosures and other company communications in one place. Readers can use it to monitor trial timelines, regulatory plans, subsidiary activities and financial reporting that Roivant discloses through its press releases and SEC filings.
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 (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.
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.