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 (ROIV)/b) reported topline results from Period 1 of Immunovant’s proof-of-concept trial of IMVT-1402 (imeroprubart) in cutaneous lupus erythematosus (CLE).The study did not achieve statistical significance on its primary endpoint of percent change from baseline in CLASI-A score at Week 12, and Immunovant plans to stop development of IMVT-1402 in CLE. Numerical trends favored IMVT-1402 over placebo across multiple endpoints, with deeper IgG reductions associated with better clinical responses. IMVT-1402 showed a favorable safety and tolerability profile consistent with prior studies, and all other IMVT-1402 clinical development timelines in autoimmune indications remain on track.
Immunovant (IMVT) reported topline results from Period 1 of its proof-of-concept trial of IMVT-1402 (imeroprubart) in cutaneous lupus erythematosus (CLE), where the study did not achieve statistical significance on the primary endpoint of CLASI-A percent change from baseline at Week 12.
Numerical trends favored IMVT-1402 over placebo on multiple endpoints, and patients with deeper IgG reductions were more likely to show improved clinical responses, but these results did not meet the company’s internal bar to continue IMVT-1402 development in CLE. IMVT-1402 showed a favorable safety and tolerability profile consistent with prior studies, and the company stated that all other clinical development timelines for IMVT-1402 in autoimmune diseases such as Graves’ disease, difficult-to-treat rheumatoid arthritis, myasthenia gravis, chronic inflammatory demyelinating polyneuropathy, and Sjogren’s disease remain on track.
Roivant (ROIV) reported positive Phase 2 PHocus results for mosliciguat in pulmonary hypertension associated with interstitial lung disease (PH-ILD) and has initiated the Phase 3 PHrontier study.
PHocus met its primary endpoint with a placebo-adjusted pulmonary vascular resistance reduction of -56.3% at Week 16 (p<0.0001). Key secondary endpoints were also met, including a placebo-adjusted +35.2-meter gain in six-minute walk distance (6MWD, p=0.0027) and a -357.7 pg/mL (placebo-adjusted, -53.2%) reduction in NT-proBNP (p=0.0002). Pre-specified exploratory Week 24 analyses showed further placebo-adjusted improvements, with 6MWD rising to +52.7 meters and NT-proBNP falling by -487.1 pg/mL (-75.9%; both nominal p<0.0001).
Mosliciguat was observed to be well tolerated, with adverse events consistent with PH-ILD and a lower cough incidence than placebo (12.1% vs. 18.2%). The ongoing PHrontier trial in PH-ILD has begun enrollment, and results are being presented at the 2026 European Respiratory Society Congress.
Roivant (ROIV) and Pulmovant will present topline Phase 2 PHocus results for mosliciguat in patients with pulmonary hypertension associated with interstitial lung disease at the European Respiratory Society International Congress 2026 at 12:15 CEST (6:15 a.m. ET) on Tuesday, September 8, 2026.
The talk will be given by Marc Humbert, MD, PhD. Roivant will also host an investor call and webcast at 8:00 a.m. ET the same day, with access details and an archived webcast available in the Investors “Events & Presentations” section of its website.
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.
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) 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.
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.