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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.
Roivant (Nasdaq: ROIV) has been recognized on Fortune Media and Great Place To Work's 2025 Best Workplaces in BioPharma List, ranking 28th place in the small & medium category. This marks the company's first appearance on this prestigious list.
The selection process involved analyzing survey responses from nearly 40,000 employees across Great Place To Work Certified companies in the biotech and pharmaceutical industry. The evaluation was based on the Trust Index Survey, which considered data from over 1.3 million survey responses representing more than 8.4 million employees.
Immunovant (Nasdaq: IMVT) has revealed promising six-month remission data for batoclimab in treating uncontrolled Graves' disease. In a proof-of-concept study, approximately 80% (17/21) of patients maintained normal thyroid function six months after treatment cessation, with 50% (8/17) of responders achieving anti-thyroid drug (ATD) free remission.
The study involved a 24-week treatment period with batoclimab administered subcutaneously, followed by a 24-week off-treatment follow-up. The treatment demonstrated strong durability, with an additional 30% (5/17) of responding patients requiring only minimal ATD doses. Safety and tolerability were consistent with previous batoclimab studies.
Two potentially registrational trials for IMVT-1402, the company's lead compound, are currently enrolling patients, with topline results expected in 2027.
Roivant Sciences (Nasdaq: ROIV) reported Q1 2025 financial results and business updates. The company maintained a strong financial position with $4.5 billion in consolidated cash and marketable securities as of June 30, 2025. Key highlights include completion of a $1.5 billion share repurchase program, reducing outstanding shares by over 15%, and board approval for an additional $500 million buyback program.
Financial results showed R&D expenses increased to $152.9 million from $120.5 million year-over-year, while G&A expenses rose to $134.0 million. The company reported a net loss from continuing operations of $273.9 million ($0.33 per share).
Clinical progress remains on track with multiple milestone readouts expected, including brepocitinib's Phase 3 VALOR study in dermatomyositis in H2 2025 and IMVT-1402's advancement in six indications.