ROIV — what changed in the latest 10-Q

Text added vs the prior filing · source: 10-Q · 2026-08-06

• BrepocitinibDermatomyositisPriovantSmall MoleculePDUFA Date 3Q 2026

• BrepocitinibLichen PlanopilarisPriovantSmall MoleculePhase 2b/3*

• 4.The reference to “Genevant” in the table above is to Genevant Sciences Ltd. Please see Note 14, “Subsequent Events” for additional detail on the expected distribution to Genevant’s non-Roivant equity holders, including Arbutus, of a portion of the $771.6 million Fixed Payment Genevant received fro…

• BrepocitinibPriovantFDA decision on brepocitinib in dermatomyositis3Q 2026

• IMVT-1402ImmunovantFurther updates from difficult-to-treat rheumatoid arthritis program2H 2026

Text removed vs the prior filing · source: 10-Q · 2026-02-06

• Topline data from both Phase 3 trials in thyroid eye disease

• Topline data from potentially registrational trial in ACPA+ difficult-to-treat rheumatoid arthritis

• IMVT-1402ImmunovantTopline data from potentially registrational trial in Sjögren’s disease2028

• Note: References under “Expected Timing” are to calendar years. All catalyst timings are based on current expectations and, where applicable, contingent on FDA feedback, and may be subject to change. The timing of the litigation-related events noted above is subject to change, including at the discr…

• •Priovant: In February 2026, Priovant announced positive Phase 2 results for brepocitinib in cutaneous sarcoidosis ("CS"). Brepocitinib 45 mg significantly improved CS disease activity, achieving a 22.3-point improvement in mean CSAMI-A at Week 16 versus a 0.7-point improvement in placebo (Δ21.6 p<0…

Text added vs the prior filing · source: 10-Q · 2026-08-06

• As of June 30, 2026, we were exposed to price risk on equity securities included in our portfolio of investments, the most significant of which were our investments in Arbutus and Datavant. Our investments in Arbutus and Datavant are measured at fair value with any changes in fair value recognized i…

Text removed vs the prior filing · source: 10-Q · 2026-02-06

• presented would not have a material effect on our financial condition or unaudited condensed consolidated financial statements.

• As of December 31, 2025, we were exposed to price risk on equity securities included in our portfolio of investments, the most significant of which were our investments in Arbutus and Datavant. Our investments in Arbutus and Datavant are measured at fair value with any changes in fair value recogniz…

Text added vs the prior filing · source: 10-Q · 2026-08-06

• Our business involves a high degree of risk. You should carefully consider the risks described in “Part I, Item 1A. Risk Factors” of our Annual Report, together with the other information contained in this Quarterly Report, including the section entitled “Management’s Discussion and Analysis of Fina…

• •changes to our statistical analysis plans or the method of calculating primary or secondary endpoints, including changes required by, or subsequently rejected by, the FDA or other regulatory authorities;

• regulatory authorities, as the case may be, and may ultimately lead to the denial of marketing approval of any of our product candidates.

• Further, other parties, including our collaborators or regulatory agencies, may not accept or agree with our assumptions, estimates, calculations, conclusions or analyses or may interpret or weigh the importance of data differently, which could impact the value of the particular program, the approva…

• In addition, our analyses, interpretations, and presentation of clinical trial data may evolve over time, including through changes to primary or secondary endpoints, statistical methods, endpoint hierarchies, or the methodologies used to calculate or present them. We may make these changes to ongoi…

Text removed vs the prior filing · source: 10-Q · 2026-02-06

• Our business involves a high degree of risk. You should carefully consider the risks described below, together with the other information contained in this Quarterly Report, including our unaudited condensed consolidated financial statements and the related notes appearing elsewhere in this Quarterl…

• Unless the context otherwise requires, references in this section to “we,” “us,” “our,” “Roivant” and the “Company” refer to Roivant Sciences Ltd. and its subsidiaries and affiliates, as the context requires. References to our “product candidates” include our current and any future products or produ…

• Our relatively limited operating history and the inherent uncertainties and risks involved in biopharmaceutical product development and commercialization may make it difficult for us to execute on our business model and for you to assess our future prospects.

• We are a clinical-stage biopharmaceutical and healthcare technology company with a relatively limited operating history upon which you can evaluate our business and prospects. We were formed in April 2014, and our operations to date have primarily been limited to acquiring or in-licensing product ca…

• Our ability to execute on our business model, successfully develop and commercialize product candidates and eventually generate revenues from the sales of our product candidates following regulatory approvals depends on a number of factors, including our ability to: