Roivant Sciences (NASDAQ:ROIV) saw its shares climb 15% after the company disclosed positive Phase 2 results for brepocitinib in cutaneous sarcoidosis, a condition noted in the trial for being highly resistant to treatment. The data, reported from the BEACON study, showed a marked clinical advantage over placebo for the 45 mg dose at the prespecified 16-week timepoint.
Specifically, brepocitinib 45 mg achieved a 22.3-point mean improvement in CSAMI-A (Cutaneous Sarcoidosis Activity and Morphology Instrument - Activity score) at Week 16, compared with a 0.7-point improvement in the placebo arm. That equates to a statistically significant treatment effect of 21.6 points in favor of brepocitinib on the primary efficacy measure.
Beyond the primary endpoint, the company reported that brepocitinib produced 100% response rates on multiple endpoints within the study population, despite enrolling patients characterized as highly treatment-resistant. Those response rates were highlighted by Roivant as notable given the refractory nature of the enrolled cohort.
Priovant, a Roivant subsidiary, intends to pursue a pivotal development path for cutaneous sarcoidosis, moving toward a Phase 3 program after engaging with the U.S. Food and Drug Administration. The company plans to initiate the Phase 3 study in 2026. This will be the third indication for brepocitinib to reach a pivotal-program stage, following a recent New Drug Application submission to the FDA for dermatomyositis.
The company also provided updates on other clinical programs. Roivant said its IMVT-1402 trial, targeting difficult-to-treat rheumatoid arthritis and described as potentially registrational, is now fully enrolled, with topline results expected in the second half of 2026. Separately, Pulmovant’s Phase 2 study of mosliciguat in pulmonary hypertension associated with interstitial lung disease has completed enrollment.
On its financial position, Roivant reported consolidated cash, cash equivalents, restricted cash and marketable securities totaling $4.5 billion as of December 31, 2025. The company stated that this liquidity supports its cash runway into profitability.
Commenting on the BEACON findings, Dr. Misha Rosenbach, Director of the Cutaneous Sarcoidosis Program at the Hospital of the University of Pennsylvania, said: "The BEACON study is a watershed moment for the sarcoidosis field, and most importantly, for our patients. This is the sort of data you dream of seeing when you look at trial results - and I would call this a transformational moment for sarcoidosis."
The clinical readout and the pathway toward a Phase 3 program, together with the company’s stated cash position, are the proximate drivers for the market reaction. Investors appear to have reacted to both the strength of the efficacy signal in a difficult-to-treat population and the visibility provided by the projected development timeline for brepocitinib.
What to watch next - Progression of the Phase 3 program planning following FDA engagement; timing and design details for the pivotal study; topline data timing for IMVT-1402 in difficult-to-treat rheumatoid arthritis expected in H2 2026; any updates on Pulmovant’s mosliciguat program.