Roivant Reports Financial Results for the Fourth Quarter and Fiscal Year Ended March 31, 2026 and Provides Business Update

Roivant Highlights Positive IMVT-1402 Data and Brepocitinib Breakthrough Designation

Roivant Sciences reported its financial results for the fourth quarter and fiscal year ended March 31, 2026, alongside a comprehensive business update. Key highlights include positive preliminary Period 1 data from the IMVT-1402 trial in difficult-to-treat rheumatoid arthritis (D2T RA), showing ACR20, ACR50, and ACR70 response rates of 72.7%, 54.5%, and 35.8% respectively at Week 16. Additionally, brepocitinib received Breakthrough Therapy Designation from the FDA for cutaneous sarcoidosis (CS) based on positive Phase 2 data, with a commercial launch in dermatomyositis (DM) anticipated by the end of September 2026. The company also announced a significant $2.25 billion global settlement with Moderna, resolving patent-infringement litigation. Roivant ended the fiscal year with $4.3 billion in cash, cash equivalents, and marketable securities.

• IMVT-1402 Demonstrates Strong Efficacy in D2T RA: Preliminary Period 1 results from the IMVT-1402 trial in difficult-to-treat rheumatoid arthritis (D2T RA) showed robust efficacy. At Week 16, participants receiving weekly subcutaneous IMVT-1402 600 mg achieved ACR20, ACR50, and ACR70 response rates of 72.7%, 54.5%, and 35.8% respectively. This data, from 165 evaluable patients who had failed multiple prior advanced therapies, indicates significant potential for this FcRn inhibitor in a challenging patient population.
• Brepocitinib Advances with Breakthrough Designation and Upcoming Launch: Brepocitinib secured Breakthrough Therapy Designation from the FDA for cutaneous sarcoidosis (CS) following positive Phase 2 BEACON study results, which showed a 22.3-point improvement in mean CSAMI-A at Week 16 versus 0.7-point for placebo. The New Drug Application (NDA) for brepocitinib in dermatomyositis (DM) was accepted with Priority Review, targeting a commercial launch by the end of September 2026. A potentially registrational Phase 2b/3 trial in lichen planopilaris (LPP) has also commenced.
• Significant Financial Settlement and Strong Cash Position: Roivant announced a $2.25 billion global settlement with Moderna, resolving all pending patent-infringement litigation. This includes an upfront payment of $950 million in July 2026, with an additional $1.3 billion contingent on a favorable appeal resolution. The company reported a strong financial position with $4.3 billion in consolidated cash, cash equivalents, and marketable securities as of March 31, 2026, providing a cash runway into profitability.
• Strategic Pipeline Focus with Batoclimab Discontinuation: Following topline results from two Phase 3 studies in thyroid eye disease (TED) that did not meet primary endpoints, Roivant discontinued further development of batoclimab across all indications. This strategic decision allows the company to fully concentrate on advancing IMVT-1402, leveraging learnings from the batoclimab program to potentially accelerate IMVT-1402's development in its various autoimmune indications.

Addressing the Challenges in Difficult-to-Treat RA

Current treatment approaches for difficult-to-treat rheumatoid arthritis face multiple interconnected challenges that significantly impact patient care and outcomes. These limitations span from therapeutic efficacy gaps to standardization issues in clinical assessment, creating barriers to optimal disease management.

• Therapeutic Efficacy Gaps: Despite advances in therapy, conventional synthetic disease-modifying antirheumatic drugs (csDMARDs) and biologic DMARDs (bDMARDs) continue to show limitations including inadequate responses in certain patient subgroups, with a large segment of the RA population experiencing insufficient response to both conventional and biologic therapies

• Safety and Adverse Event Profile: Current treatments carry significant safety concerns including metabolic disorders, increased infection risk, drug resistance development, elevated herpes zoster risk (particularly in Asian populations), liver enzyme abnormalities, and potential cardiovascular events

• Economic Barriers: Cost remains a major treatment barrier, with annual expenses exceeding USD 60,000 for uninsured patients, though partially mitigated by insurance coverage, while high costs associated with biologic therapies continue to limit accessibility

• Clinical Assessment Standardization Issues: There is little to no consensus on what constitutes treatment failure or adequate response, with current American College of Rheumatology response criteria and disease activity scores potentially underestimating treatment failure magnitude in clinical practice

• Monitoring and Evaluation Challenges: Existing assessment criteria, designed for large group differentiation, demonstrate limited value for individual patient monitoring, with variability in clinical definitions of treatment failure or remission attributed to timing of assessments

• Treatment Decision-Making Complexity: Key unresolved issues include determining optimal next-line therapies for maintaining tight disease control and establishing the appropriate positioning of newly approved therapies within the current RA treatment armamentarium

Brepocitinib's Ascent: Roivant's Strategic Play in Autoimmunity

Roivant Sciences is strategically positioning itself as a significant player in the autoimmune and inflammatory disease landscape, leveraging a multi-pronged approach anchored by its TYK2/JAK1 inhibitor, brepocitinib, and a robust financial foundation. The anticipated commercial launch of brepocitinib in dermatomyositis (DM) by late 2026 is a critical milestone, addressing a rare and debilitating condition with substantial unmet needs. Phase 3 data for DM demonstrated significant benefits for the 30mg dose across multiple endpoints, including skin disease activity and glucocorticoid tapering, offering a much-needed therapeutic option.

Further bolstering its potential, brepocitinib has received Breakthrough Therapy Designation for cutaneous sarcoidosis (CS), signaling accelerated development and review for another difficult-to-treat inflammatory disease. This dual focus on rare, high-need indications could establish brepocitinib's value proposition early. Its mechanism as a selective TYK2/JAK1 inhibitor is designed to target specific cytokine pathways, potentially offering a differentiated safety and efficacy profile compared to broader JAK inhibitors. This selectivity is crucial, as the broader JAK inhibitor class faces scrutiny due to class-wide safety concerns, including risks of serious infections and cardiovascular events. While brepocitinib's trials have shown an acceptable safety profile, specific adverse events like elevated creatinine and increased serious infections in certain populations warrant careful monitoring.

Beyond brepocitinib, the positive preliminary data for IMVT-1402 in difficult-to-treat rheumatoid arthritis highlights Roivant's broader pipeline ambitions in larger autoimmune markets. The company's substantial cash reserves, augmented by a significant patent settlement, provide ample resources to drive these programs forward, support commercialization efforts, and navigate the complexities of drug development and market entry. This financial strength offers strategic flexibility, enabling Roivant to invest in further research, expand its commercial footprint, and potentially explore new therapeutic avenues, solidifying its long-term growth trajectory in the competitive pharmaceutical landscape.