On December 11, 2025, Roivant Sciences Ltd. (ROIV) filed an 8-K form with the U.S. Securities and Exchange Commission. The filing disclosed positive Phase 3 clinical trial results for its drug candidate brepocitinib in dermatomyositis (DM), with a statistically significant benefit on the primary endpoint and a p-value of 0.0006.

In the Phase 3 VALOR trial for dermatomyositis, brepocitinib 30 mg achieved a mean Total Improvement Score (TIS) of 46.5 compared to 31.2 for placebo, according to the filing. The company stated it plans to submit a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for this indication in early 2026.

Roivant Sciences also reported financial updates, including a cash and equivalents position of $4.4 billion as of September 30, 2025. The company repurchased $1.5 billion worth of its shares at an average price of $10.09 per share, according to the SEC document.

For its other drug candidate, IMVT-1402, the filing noted a 63 percent ATD-free response rate in a Phase 2a trial for Graves disease (GD). In a Phase 3 trial for myasthenia gravis (MG), 67 percent of participants achieved aINCAT improvement with IMVT-1402, the company reported.

The 8-K filing indicated upcoming clinical milestones, including topline data from the Phase 3 CLARITY trial of brepocitinib in non-infectious uveitis (NIU) expected in the second half of 2026. Topline data from the Phase 2 BEACON trial of brepocitinib in cutaneous sarcoidosis (CS) is expected in the first half of 2026.

Several company executives presented at the event referenced in the filing, including CEO Matt Gline of Roivant, CEO Ben Zimmer of Priovant, CEO Drew Fromkin of Pulmovant, and CFO Richard Pulik of Roivant. The information was sourced from exhibits 99.1 and 99.2 attached to the SEC filing.