Roivant Sciences is preparing for the potential FDA approval of its lead drug candidate, brepocitinib, for the treatment of dermatomyositis (DM). The FDA has granted Priority Review for brepocitinib in DM, with a target action date in the third quarter of calendar year 2026. If approved, brepocitinib is expected to launch by the end of September 2026. This would mark a significant milestone for Roivant, as brepocitinib would be the first targeted therapy for this rare inflammatory disease.
In addition to the DM program, Roivant's subsidiary, Priovant, reported positive results from the Phase 2 BEACON study of once-daily oral brepocitinib in cutaneous sarcoidosis (CS). The drug demonstrated statistically significant improvements, with a 22.3-point improvement in mean CSAMI-A at Week 16 compared to 0.7-point improvement in placebo. Based on these findings, the FDA granted brepocitinib Breakthrough Therapy Designation for CS, with a Phase 3 program expected to begin in the second half of 2026. Priovant also initiated a seamless Phase 2b/3 trial for brepocitinib in lichen planopilaris (LPP) in March 2026.
Immunovant, another Roivant subsidiary, announced positive Week 16 results 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. Further updates on this program, along with topline data from a proof-of-concept trial in cutaneous lupus erythematosus (CLE), are anticipated in the second half of 2026. Roivant ended the fiscal year on March 31, 2026, with consolidated cash, cash equivalents, and marketable securities totaling $4.3 billion. Analysts have expressed a bullish outlook on Roivant's stock, with a consensus price target of $35.71, implying a 25% upside from current levels, though EPS and revenue estimates have seen recent downward revisions.
