Roivant reported third quarter fiscal 2025 financial results and highlighted new Phase 2 data for brepocitinib (BREPA) in cutaneous sarcoidosis, alongside a series of clinical and corporate updates that management described as evidence of “terrific execution and progress across the board.” CEO Matt Gline and Priovant CEO Ben Zimmer also discussed upcoming catalysts in 2026, including multiple clinical readouts and a scheduled March 9 jury trial in Roivant’s case against Moderna.
Phase 2 cutaneous sarcoidosis results: early separation and high responder rates
Zimmer said cutaneous sarcoidosis is “a really debilitating skin disease” with rapid progression toward permanent scarring and disfigurement, and noted there are no approved therapies for any form of sarcoidosis. He positioned BREPA’s mechanism—dual inhibition affecting TH1-related pathways via TYK2 and interferon gamma via JAK1—as aligned with the disease biology.
On efficacy, the company emphasized consistent improvements across physician- and patient-reported endpoints:
- CSAMI activity score: Both BREPA doses separated from placebo as early as week 4 and maintained separation through week 16, with statistical significance at every visit, according to Zimmer.
- Investigator’s Global Assessment (IGA) 0/1 with ≥2-point improvement: Zimmer described this as a high bar; no placebo patients achieved it. He said separation versus placebo emerged over time and that 45 mg began to separate from 15 mg on this more stringent endpoint.
- Responder outcomes: Management highlighted that 100% of patients on BREPA 45 mg achieved at least a 10-point improvement in CSAMI. Zimmer also noted 62% of patients on BREPA 45 mg reached an absolute CSAMI score <5 (described as a functional remission threshold), versus none on placebo.
- Patient-reported outcomes: Zimmer cited improvements on SKINDEX-16 and the King Sarcoidosis Questionnaire (KSQ) skin domain, with placebo worsening on SKINDEX-16. He also noted that on Patient Global Impression of Change, 100% of patients in the 45 mg arm reported improvement.
Gline said the placebo-adjusted improvement was a 21.6-point delta on CSAMI with statistical significance, adding that the study was “not powered for efficacy in this endpoint.” He also characterized the results as notable given management’s prior view that a 5-point CSAMI change would be clinically meaningful.
Safety: no serious adverse events reported in the trial
Zimmer said BREPA was “very well tolerated” in the cutaneous sarcoidosis study, with no serious adverse events and all adverse events graded mild or moderate. He added that the findings were consistent with the broader brepocitinib database, which he said includes data from more than 1,500 patients.
Development plans: Phase 3 in cutaneous sarcoidosis and broader BREPA expansion
Management said it plans to move into Phase 3 for cutaneous sarcoidosis in 2026, while also preparing for other key pipeline milestones. Gline said an NDA for BREPA in dermatomyositis has been submitted, and he reiterated that a pivotal Phase 3 readout in non-infectious uveitis (NIU) is expected in the second half of 2026. He also said the company expects to start a Phase 3 study in cutaneous sarcoidosis this year.
On questions about potential erosion of effect size in Phase 3, Zimmer said the Phase 2 results provide “an incredible cushion,” while acknowledging that placebo behavior can shift in larger global inflammatory disease trials. The company said it will provide additional Phase 3 design details after FDA engagement, including powering and the safety database expectations for approval.
When asked about expanding BREPA to additional indications, Gline said the company is “absolutely enthusiastic” about further development, and Zimmer added that the data reinforces the company’s hypotheses about where TYK2/JAK1 inhibition may be particularly distinctive, including diseases driven by TH1 and TH17 pathways.
Other pipeline updates: Immunovant (NASDAQ:IMVT) and mosliciguat program progress
Gline provided updates across Roivant’s portfolio, including Immunovant’s FcRn program IMVT-1402. He said the Phase 2B study of IMVT-1402 in “DTT-RA” (as referenced on the call) is fully enrolled, and that enrollment reached 170 patients, up from the originally anticipated 120, which he attributed to rapid recruitment and physician and patient enthusiasm. He also said the company expects proof-of-concept data in IMVT-1402 in cutaneous lupus erythematosus (CLE) and reiterated expectations for pivotal data in Graves’ disease in 2027.
For Pulmovant’s mosliciguat in pulmonary hypertension associated with interstitial lung disease (PH-ILD), Gline said the Phase 2 study is fully enrolled and that top-line Phase 2B data are expected in the second half of 2026. He described PH-ILD as an area with limited existing therapies and suggested a once-daily regimen could be advantageous versus multiple daily inhalations in the current landscape.
Financial results and legal catalyst: $4.5 billion in cash and Moderna trial scheduled
Roivant reported third quarter R&D expense of $165 million (adjusted non-GAAP $147 million) and G&A expense of $175 million (adjusted non-GAAP $71 million), resulting in a non-GAAP net loss of $167 million for the quarter. Gline said the company ended the period with $4.5 billion of consolidated cash, which he characterized as sufficient to reach profitability while retaining flexibility, including an existing share buyback authorization.
On the legal front, Gline reiterated that the jury trial in Roivant’s case against Moderna is scheduled to begin March 9. He also noted the company received the first summary judgment decisions earlier in the week and said Roivant was “quite happy” with a favorable decision related to Section 1498, which he said supports the scope of doses expected to be covered at trial.
About Immunovant (NASDAQ:IMVT)
Immunovant Inc is a clinical-stage biopharmaceutical company focused on the development of novel monoclonal antibody therapies that target the neonatal Fc receptor (FcRn) to treat severe autoimmune diseases. By inhibiting FcRn, Immunovant’s approach is designed to reduce levels of pathogenic immunoglobulin G (IgG) antibodies, which play a central role in the pathology of disorders such as myasthenia gravis and immune thrombocytopenia.
The company’s lead asset, efgartigimod, is an engineered Fc fragment that selectively binds to FcRn, accelerating the degradation of circulating IgG.
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