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, a Roivant (Nasdaq: ROIV) company, announced U.S. FDA approval of LISRAYA™ (brepocitinib) 30 mg, a once-daily, first-in-class TYK2/JAK1 inhibitor for the treatment of adults with dermatomyositis (DM). LISRAYA is the first and only targeted therapy approved for DM and is available immediately in the U.S. via specialty pharmacies.
Approval is based on the 52-week Phase 3 VALOR trial, the largest DM study conducted, where 55% of LISRAYA patients achieved moderate-or-better improvement on the myositis Total Improvement Score with minimal/no steroid use versus 30% on placebo. Among those on ≥7.5 mg/day steroids at baseline, 62% on LISRAYA tapered to ≤2.5 mg/day (vs 38% placebo), and 45% discontinued steroids entirely (vs 29% placebo). Common adverse reactions included upper respiratory tract infection, headache, fatigue, and urinary tract infection. LISRAYA carries a boxed warning for serious infections, mortality, malignancy, major adverse cardiovascular events (MACE), and thrombosis, and is not recommended in severe hepatic or renal impairment. A patient support program, LISRAYA My Compass Support, may allow eligible patients to pay as little as $0 per month.
Roivant Sciences (NASDAQ: ROIV), via Priovant Therapeutics, reported that JAMA Dermatology published skin-specific Phase 3 VALOR data for oral TYK2/JAK1 inhibitor brepocitinib 30 mg in adults with dermatomyositis.
At Week 52, 61.7% of patients achieved a clinically meaningful CDASI-A response versus 44.3% with placebo. Among those with at least moderate skin disease at baseline, 45.7% on brepocitinib reached “Clear”/“Almost Clear” on IGA and 43.5% achieved functional skin remission (CDASI-A ≤5), versus 21.8% and 20.8% on placebo. In patients with at least moderate itch at baseline, 54.0% on brepocitinib reached clinically meaningful itch reduction by Week 4 versus 9.5% with placebo, rising to 74.0% versus 33.3% by Week 52. Skin-related quality of life (Skindex-16) improved by 12.9 points by Week 4 with brepocitinib versus 0.9 with placebo. Among oral corticosteroid users at baseline, 61.7% on brepocitinib tapered to ≤2.5 mg/day and 41.7% discontinued steroids by Week 52, compared with 34.4% and 23.4% on placebo. Serious infections occurred more often with brepocitinib but resolved with medical management.
Roivant (Nasdaq: ROIV) reported first-quarter 2026 net loss of $290.6 million (non-GAAP net loss $243.7 million) on revenue of $1.4 million. R&D rose to $202.0 million and G&A to $165.5 million, partly due to bonuses tied to the Moderna settlement.
Roivant held $3.9 billion in cash, cash equivalents, restricted cash and marketable securities as of June 30, 2026, excluding $950 million received in July by Genevant and Arbutus under a $2.25 billion Moderna settlement. Roivant repurchased 7.3 million shares for $208.7 million.
Commercial preparations for brepocitinib in dermatomyositis remain on track for launch by end of September 2026, with multiple Phase 3 and proof-of-concept trials ongoing or enrolling across brepocitinib, IMVT-1402 and mosliciguat. Genevant also filed new international patent lawsuits against Pfizer and BioNTech.
Immunovant (Nasdaq: IMVT) reported corporate updates and financial results for its fiscal first quarter ended June 30, 2026. All IMVT-1402 clinical development timelines remain on track across six indications, including Graves’ disease (GD), myasthenia gravis (MG), CIDP, difficult-to-treat rheumatoid arthritis, Sjögren’s disease and cutaneous lupus erythematosus.
The company plans potentially registrational IMVT-1402 data readouts in GD and MG in 2027, and in CIDP and SjD in 2028, with a CLE proof‑of‑concept readout and D2T RA program update expected in the second half of 2026. As of June 30, 2026, cash and cash equivalents were $797.8 million, which Immunovant says provides runway to the potential commercial launch of IMVT-1402 in GD under its current plan.
For the quarter, R&D expenses were $142.6 million versus $101.2 million a year earlier, while G&A expenses declined to $17.7 million from $26.0 million. Net loss was $153.2 million, or $0.75 per share, compared with $120.6 million, or $0.71 per share, in the prior-year period. Non‑GAAP net loss was $139.4 million, up from $102.1 million. Roivant (Nasdaq: ROIV) will host a conference call and webcast on August 6, 2026, at 8:00 a.m. ET.
Priovant (NASDAQ: ROIV) announced enrollment of the first patients in BEACON+, a global Phase 3 study of brepocitinib in cutaneous sarcoidosis (CS). The trial will randomize about 140 patients across ~70 sites to brepocitinib 45 mg once daily or placebo (3:2). The primary endpoint is the proportion of patients achieving ≥50% reduction in CSAMI-A at Week 16.
According to Priovant, Phase 2 BEACON showed 77% of brepocitinib 45 mg patients met this endpoint versus 0% on placebo, supporting FDA Breakthrough Therapy Designation in CS. Topline BEACON+ data are expected in 2028. Brepocitinib’s registrational program now spans four orphan indications: dermatomyositis (DM), non-infectious uveitis (NIU), lichen planopilaris (LPP), and CS. The DM NDA is under FDA Priority Review with a PDUFA date later this quarter, and a potential approval and launch are expected by the end of September 2026.
Roivant (Nasdaq: ROIV) will host a live conference call and webcast at 8:00 a.m. ET on Thursday, August 6, 2026 to report financial results for the first quarter ended June 30, 2026 and provide a business update. Phone participants must register online, while webcast and presentation details will be available under “Events & Presentations” in the Investors section of Roivant’s website. An archived webcast will be accessible after the call.
Roivant (Nasdaq: ROIV) reported Q4 FY 2026 income from continuing operations of $355.7 million, reversing a prior-year quarterly loss, while full-year loss from continuing operations narrowed to $397.9 million. Cash, cash equivalents and marketable securities totaled $4.3 billion, supporting a runway into profitability.
Key updates include strong IMVT-1402 D2T RA responses, FDA Priority Review for brepocitinib in dermatomyositis, Breakthrough Therapy Designation in cutaneous sarcoidosis, and a $2.25 billion global patent-litigation settlement with Moderna, including $950 million payable by July 2026 and a contingent $1.3 billion.
Roivant (Nasdaq: ROIV) will host a live conference call and webcast at 8:00 a.m. ET on May 20, 2026 to discuss financial results for the fourth quarter and fiscal year ended March 31, 2026 and provide a business update. Access details and an archived webcast will be available in the Investors section of Roivant’s website.
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.