Roivant Sciences(US:ROIV) Globenewswire·2026-02-06 12:00Core Insights - Roivant announced positive Phase 2 results for brepocitinib in cutaneous sarcoidosis, marking a significant breakthrough in treatment options for this condition [1][2][10] - The company reported a consolidated cash position of approximately $4.5 billion as of December 31, 2025, supporting its financial stability and ongoing development efforts [12][17] Clinical Development - The BEACON study involved 31 patients and demonstrated that brepocitinib 45 mg resulted in a 22.3-point improvement in mean CSAMI-A at Week 16 compared to a 0.7-point improvement in placebo, with statistical significance (Δ21.6, P<0.0001) [3][4][10] - Brepocitinib 45 mg achieved a 100% response rate on multiple endpoints, with 62% of patients reaching functional remission (CSAMI-A <5) compared to 0% in the placebo group [5][6] - The company plans to initiate a Phase 3 study for cutaneous sarcoidosis in 2026, following engagement with the FDA, representing the third pivotal program for brepocitinib [4][8][10] Financial Performance - Research and development expenses increased by $23.8 million to $165.4 million for Q3 2025, driven by program-specific costs and share-based compensation [13][15] - General and administrative expenses rose by $33.5 million to $175.1 million for the same period, primarily due to an impairment loss related to the relocation of the corporate headquarters and increased share-based compensation [16][18] - The company reported a loss from continuing operations of $313.7 million for Q3 2025, compared to a loss of $208.9 million for the same period in 2024 [20][21] Upcoming Milestones - Topline data from Phase 3 studies in non-infectious uveitis are expected in the second half of 2026, along with data from trials for other indications of brepocitinib and IMVT-1402 [4][10][17] - A jury trial in the U.S. Moderna case is scheduled for March 2026, with significant developments anticipated in ongoing litigation [17][10]