Roivant said it has expanded brepocitinib’s late-stage development program with a new seamless phase 2b/3 study in lichen planopilaris, a scarring alopecia affecting about 100,000 adults in the U.S. The company said the first subjects were enrolled in March 2026, making lichen planopilaris the fourth indication in the drug’s late-stage pipeline.
The new program comes as brepocitinib is already in late-stage development for dermatomyositis, non-infectious uveitis and cutaneous sarcoidosis. Roivant said the FDA recently granted priority review to the dermatomyositis application and set a PDUFA target action date in the third quarter of 2026. It also said topline phase 3 data in non-infectious uveitis and phase 3 initiation in cutaneous sarcoidosis are expected in the second half of 2026.
Roivant highlighted the medical burden of lichen planopilaris, saying the disease causes generally irreversible hair loss and permanent scarring, often with pain, itching, burning and scaling. The company said no FDA-approved treatments exist for the condition.
On the immunovant side of the business, the company reported that both phase 3 studies of batoclimab in thyroid eye disease missed their primary endpoint of at least a 2 mm proptosis responder rate at week 24. The studies used 12 weeks of high-dose treatment followed by 12 weeks of low-dose treatment. Roivant said safety was consistent with prior findings and no new safety signals were identified.
Roivant said patients in the thyroid eye disease studies showed more proptosis improvement after the first 12-week high-dose period than during the following 12-week low-dose period, a result the company said supports deeper IgG suppression. In the subset of hyperthyroid patients, thyroid hormone normalization rates were similar to those seen in batoclimab’s phase 2 Graves’ disease study.
The company said immunovant is now focused on advancing IMVT-1402 across multiple autoimmune diseases, with Graves’ disease as a key priority. Topline data from the potentially registrational Graves’ disease studies are expected in 2027.
Roivant also said it will discuss the updates on a conference call at 8:00 a.m. ET on April 2, 2026. Today the company's shares have moved -0.04% to a price of $27.35. For the full picture, make sure to review Roivant Sciences's 8-K report.
