Shares of Roivant Sciences (ROIV 0.04%) are soaring 11.4% higher as of 11:19 a.m. ET on Wednesday. The big gain came after Roivant and Priovant Therapeutics announced positive results from a late-stage clinical study evaluating brepocitinib in treating dermatomyositis, an autoimmune disease that can cause muscle weakness and skin lesions.
Patients receiving a once-daily 30 mg dose of oral brepocitinib experienced statistically significant improvement compared to placebo on the primary endpoint of the phase 3 clinical study as well as all nine key secondary endpoints. Brepocitinib's safety profile was also encouraging, with adverse events of special interest such as malignancy, cardiovascular events, and thromboembolic events not occurring at a greater frequency than with patients in the placebo arm of the study.
NASDAQ: ROIV
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What does this news mean for Roivant?
Priovant Therapeutics now plans to file for U.S. Food and Drug Administration (FDA) approval of brepocitinib in treating dermatomyositis in the first half of 2026. That's great news for Roivant for a simple reason: It owns 75% of Priovant.
Roivant believes that brepocitinib has the potential to become a blockbuster drug treating rare and orphan autoimmune diseases. Dermatomyositis affects around 50,000 adults in the U.S. There's only one approved therapy for the disease, and no other oral therapies are in late-stage development.
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Is Roivant stock a buy?
Roivant probably won't be appealing to risk-averse investors. However, the stock looks like a good pick for aggressive investors. In addition to brepocitinib, Roivant's pipeline features two other candidates in late-stage development, IMV-1402 and batoclimab. IMV-1402, in particular, holds the potential to be a big winner if approved.
