Roivant Highlights Strong Clinical Advancements, $2.25B Moderna Settlement, and Robust Cash Position in FY26 Update
Key Clinical Data: IMVT-1402 Achieves Notable Response Rates in Difficult-to-Treat Rheumatoid Arthritis
Roivant Sciences recently unveiled promising clinical results from its IMVT-1402 program, targeting patients with difficult-to-treat rheumatoid arthritis (D2T RA). In the 16-week open label phase, IMVT-1402 demonstrated clinically meaningful results with ACR20, ACR50, and ACR70 response rates of 72.7%, 54.5%, and 35.8%, respectively. Notably, among patients who had failed both JAK and anti-TNF inhibitors, response rates remained robust at 72.0% (ACR20), 53.3% (ACR50), and 37.4% (ACR70). These outcomes suggest that IMVT-1402 may offer new hope for patients who have exhausted other options. The drug was well-tolerated with no new safety signals, and additional updates are anticipated in the second half of calendar year 2026.
| Population | ACR20 | ACR50 | ACR70 |
|---|---|---|---|
| All evaluable (N=165) | 72.7% | 54.5% | 35.8% |
| Failed JAK & anti-TNF (N=107) | 72.0% | 53.3% | 37.4% |
Pipeline Catalysts: Brepocitinib and Mosliciguat on Track for Late-Stage Data
Beyond IMVT-1402, Roivant continues to progress several key programs. Brepocitinib received Breakthrough Therapy Designation from the FDA for cutaneous sarcoidosis (CS), buoyed by positive Phase 2 data. A pivotal trial in lichen planopilaris (LPP) is underway, and a commercial launch for dermatomyositis (DM) is expected by the end of September 2026. Topline Phase 3 data for brepocitinib in non-infectious uveitis and for IMVT-1402 in cutaneous lupus erythematosus (CLE) are both anticipated in the second half of 2026. Roivant’s Pulmovant subsidiary also completed enrolment for the Phase 2 PHocus study in pulmonary hypertension associated with interstitial lung disease, with results expected in late 2026.
Legal Milestone: $2.25 Billion Global Settlement with Moderna Bolsters Balance Sheet
A major financial development came with the $2.25 billion global legal settlement with Moderna, ending all patent-infringement litigation brought by Genevant Sciences (a Roivant affiliate) and Arbutus. Roivant expects $950 million to be paid in July 2026, and an additional $1.3 billion could follow pending appeals. This significant cash injection strengthens Roivant’s already solid balance sheet and provides further runway to profitability.
Financial Strength: Cash, Expenses, and Non-GAAP Highlights Point to Long-Term Stability
Roivant reported $4.3 billion in cash, cash equivalents, and marketable securities as of March 31, 2026. The company’s disciplined spending supports ongoing development, with research and development (R&D) expenses totaling $198.9 million for the quarter and $681.8 million for the year, driven by expanded clinical efforts and one-time restructuring costs. General and administrative (G&A) expenses were $158.3 million for the quarter and $610.5 million for the year, with increases tied to litigation costs and share-based compensation associated with executive awards. On a non-GAAP basis, R&D and G&A expenses were $631.6 million and $294.1 million, respectively, reflecting the company’s efficiency in core operations, exclusive of certain non-cash and one-off items.
| Balance Sheet Item | Mar 31, 2026 | Mar 31, 2025 |
|---|---|---|
| Cash & Cash Equivalents | $1,419,232 | $2,715,411 |
| Marketable Securities | $2,872,601 | $2,171,480 |
| Litigation Settlement Receivable | $770,235 | - |
| Total Assets | $5,708,687 | $5,436,940 |
| Total Liabilities | $416,275 | $249,742 |
| Total Shareholders' Equity | $5,292,412 | $5,187,198 |
Profitability Improvement: Litigation Gain Drives Turnaround in Operating Results
Roivant's quarterly results saw a remarkable swing due to the litigation settlement: income from continuing operations (net of tax) reached $355.7 million for Q4 FY26, compared to a $252.4 million loss a year earlier. This turnaround, supported by the $770.2 million gain on the Moderna settlement, signals enhanced flexibility for the company to fund its robust pipeline.
Upcoming Catalysts: Multiple High-Impact Data Readouts and Product Launches on the Near Horizon
Investors and the healthcare community can expect a highly active second half of 2026, featuring:
- The anticipated launch of brepocitinib in dermatomyositis by September 2026
- Pivotal data from brepocitinib's late-stage studies in non-infectious uveitis and lichen planopilaris
- Further updates from IMVT-1402 registrational and proof-of-concept trials in multiple autoimmune indications
- Key data from ongoing studies of mosliciguat in pulmonary hypertension
Bottom Line: Well-Funded, Data-Rich Path Ahead
Backed by a strong cash position, landmark legal win, and multiple late-stage pipeline catalysts, Roivant heads into late 2026 positioned for growth and potential profitability. While execution and data readouts will be pivotal, the current trajectory underscores the company’s resilience and clinical ambition in the immunology and rare disease space. As upcoming milestones approach, the focus shifts to how these programs, particularly IMVT-1402 and brepocitinib, can convert clinical momentum into commercial impact.
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