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Roivant said its first quarter was relatively quiet operationally but positioned the company for a more active second half of 2026, with a potential launch of brepocitinib in dermatomyositis, multiple clinical readouts and further updates from Immunovant NASDAQ: IMVT.
Chief Executive Officer Matt Gline said Roivant expects a decision from the U.S. Food and Drug Administration on brepocitinib for dermatomyositis by the end of September after receiving priority review. The company said its commercial, field-support and patient-support teams are trained and prepared for a potential launch.
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“We’re ready to launch on time,” Gline said, while emphasizing that Roivant expects to build the product franchise through a “slow and steady” approach rather than focusing on early launch metrics.
Brepocitinib Programs Advance Beyond dermatomyositis, Roivant has begun enrolling patients in a Phase III trial of brepocitinib for cutaneous sarcoidosis. The 140-patient study will compare 45 milligrams of brepocitinib with placebo over 16 weeks, with a mandatory steroid taper from week two through week eight. The primary endpoint is a CSAMI response of at least 50%. Roivant expects top-line data in 2028.
Gline said the Phase III design incorporates findings from the company’s Phase II study, in which he said brepocitinib showed a greater than 20-point benefit on the CSAMI scale relative to little change on placebo. Roivant estimates there are approximately 40,000 cutaneous sarcoidosis patients in the United States.
The company also said its registrational trial of brepocitinib in lichen planus, or LPP, is enrolling “extremely well,” according to Gline. Roivant added LPP as a fourth development indication for brepocitinib earlier this year.
Top-line data from brepocitinib’s Phase III noninfectious uveitis, or NIU, study are expected during the second half of 2026. Gline said variability in placebo response rates is a key uncertainty in immunology trials, but described the company’s Phase II NIU data as compelling. He said Roivant would seek to submit a supplemental new drug application quickly if the study produces a successful result.
In discussing the planned dermatomyositis launch, Gline said the company sees no direct launch analog because no targeted therapy has previously been launched for the disease. He noted that roughly 200 myositis referral centers treat about half of the U.S. dermatomyositis population.
Gline also addressed potential safety concerns surrounding the JAK inhibitor class. He said Roivant expects brepocitinib’s label to include boxed warnings consistent with other JAK inhibitors, but added that physicians treating dermatomyositis patients are accustomed to managing substantial risks associated with current treatment options, including high-dose steroids and immunosuppressants.
Additional Data Readouts Expected Roivant expects top-line Phase II data in the second half from mosliciguat in pulmonary hypertension associated with interstitial lung disease, or PH-ILD. The company said it is primarily looking for a clear signal in pulmonary vascular resistance, or PVR. The study was not powered for six-minute walk distance, although Gline said separation on that measure would be welcome.
The mosliciguat monotherapy results will be reported before data from a separate combination study, which began later and remains in enrollment. Gline said the combination study is open-label and is intended to provide additional safety experience and information that could help guide Phase III planning.
Roivant also expects an initial proof-of-concept readout for brepocitinib in cutaneous lupus erythematosus, or CLE, during the second half. The initial results will cover 12-week data comparing the 600-milligram dose with placebo. Gline described the trial as a small, fact-finding study intended to help the company evaluate the treatment benefit and potential position in an increasingly competitive development landscape.
At Immunovant, Roivant plans to provide a broader update later this year on IMVT-1402 in difficult-to-treat rheumatoid arthritis. The update is expected to include results from the randomized-withdrawal portion of the study, feedback from an anticipated FDA discussion, and the company’s plans for future trials. Gline said the open-label response data have generated positive attention, though the randomized-withdrawal results could affect whether the study can serve as a pivotal trial.
Roivant also highlighted its Graves’ disease program for IMVT-1402, with a pivotal readout expected in 2027. Gline said the company sees substantial unmet need in Graves’ disease and views the opportunity as one of building a new treatment market rather than competing for a limited number of patients.
Moderna Payment and Capital Allocation Roivant said it received the initial payment from its settlement with Moderna. The $950 million payment included approximately $770 million for Genevant and the remainder for Arbutus. The company said its separate appellate process related to a Section 1498 matter remains ongoing and could result in an additional $1.3 billion if the outcome is favorable.
Roivant also said it filed international proceedings against Pfizer and BioNTech, including actions in Canada and the Unified Patent Court, during July.
For the quarter, Roivant reported approximately $200 million in research and development expense, nearly $100 million in non-GAAP adjusted general and administrative expense, and $166 million in GAAP general and administrative expense. Cash stood at just under $4 billion before the receipt of $772 million associated with the Moderna settlement proceeds.
The company repurchased about $200 million of shares during the quarter, with additional repurchases occurring in March. Gline said Roivant accelerated its repurchase activity following the Moderna settlement announcement and plans to continue repurchasing shares under its existing authorizations.
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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