Once-daily oral Brepocitinib 30 mg demonstrated clinically meaningful and statistically significant improvement compared to placebo on the primary endpoint and all key secondary endpoints in the study, the company said.
Shares of Roivant (ROIV) jumped 9% on Wednesday after the company, along with Priovant Therapeutics, announced positive results from a late-stage trial evaluating Brepocitinib in dermatomyositis.
Dermatomyositis is a multi-organ idiopathic inflammatory condition that affects approximately 50,000 adults in the U.S. and is characterized by debilitating muscle weakness and skin lesions. No targeted therapies are approved for the condition, and a majority of patients are treated with high-dose oral steroids.
Once-daily oral Brepocitinib 30 mg demonstrated clinically meaningful and statistically significant improvement compared to placebo on the primary endpoint and all key secondary endpoints in the study, including measurements of skin disease, muscle disease, steroid-sparing effect, and rapidity of onset, the company said.
On Stocktwits, retail sentiment around ROIV stock stayed within the ‘bullish’ territory over the past 24 hours, while message volume stayed at ‘high’ levels.
A Stocktwits user expressed optimism that the stock would rally further to $17.
Another user also cheered the stock’s rally over the past few weeks.
The company stated that 30mg of Brepocitinib achieved a week 52 mean Total Improvement Score (TIS) of 46.5 compared to 31.2 for placebo. It added that more than two-thirds of patients receiving the Brepocitinib 30 mg dose experienced at least a moderate response, with a TIS equal to or greater than 40, and nearly half experienced a major response, with a TIS equal to or exceeding 60.
Furthermore, 42% of Brepocitinib 30 mg patients were able to discontinue steroids altogether, compared to 23% for the placebo, while 62% achieved a steroid dose of 2.5 mg or less per day. The safety profile observed in the study was consistent with that of previous trials, the company stated.
The company plans to file for approval of the drug with the U.S. Food and Drug Administration for the treatment of dermatomyositis in the first half of 2026.
ROIV stock is up 31% this year and approximately 28% over the past 12 months.
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