Shares of pharmaceutical company Roivant Sciences (NASDAQ: ROIV) surged 11.4% on Wednesday following the announcement of positive results from a late-stage clinical trial for its oral drug candidate, brepocitinib, developed jointly with Priovant Therapeutics. Dermatomyositis is an autoimmune disease that can cause muscle weakness and skin lesions.
According to the results from the Phase 3 trial, patients who received a once-daily 30mg oral dose of brepocitinib showed significant improvement over the placebo group in the primary efficacy endpoint, as well as all nine key secondary endpoints. Moreover, the safety profile of brepocitinib was encouraging, with adverse events such as malignancy, cardiovascular issues, and thrombosis not occurring at a higher rate than in the placebo group.
Priovant Therapeutics plans to submit a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for brepocitinib in the treatment of dermatomyositis in the first half of 2026. This development is an important catalyst for Roivant, which owns 75% of Priovant.
Roivant believes that brepocitinib has the potential to become a blockbuster therapy for rare and orphan autoimmune diseases. It is estimated that there are about 50,000 adult dermatomyositis patients in the U.S. Currently, only one therapy has been approved for this disease, and there are no other oral medications in late-stage development, indicating huge market potential.
Roivant may not be the top choice for risk-averse investors, but for more aggressive investors seeking high growth, the stock is considered promising. In addition to brepocitinib, Roivant’s pipeline features two other late-stage drug candidates, IMV-1402 and batoclimab. If approved, IMV-1402, in particular, could become another star product for the company.
Although Roivant’s revenue fell sharply and it swung to a net loss in the first quarter of fiscal year 2026, some analysts remain bullish on the stock. Last month, David Risinger of Leerink Partners raised his price target for Roivant by $1 to $18 per share and maintained an “Outperform” (“Buy”) rating. Risinger’s revision is mainly based on the impact of the company’s stock repurchase program on share count, as well as his optimistic outlook for the Phase 3 data for brepocitinib.
