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.
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.
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.