Roivant Reports Financial Results for the Second Quarter Ended September 30, 2025, and Provides Business Update

Core Insights - Roivant is experiencing a transformative quarter, highlighted by positive data from brepocitinib in dermatomyositis and Immunovant's remission data in Graves' disease, indicating a promising trajectory for the company [2][3] Recent Developments - Brepocitinib 30 mg showed significant improvement in the Phase 3 VALOR study for dermatomyositis, with an NDA filing planned for the first half of 2026 [3][4] - The brepocitinib program is advancing with rapid enrollment in studies for non-infectious uveitis and cutaneous sarcoidosis, with readouts expected in 2027 and late 2026, respectively [3][4] - Immunovant's study in uncontrolled Graves' disease patients indicated a potentially disease-modifying outcome, with results from Phase 3 thyroid eye disease studies expected in early 2026 [3][4] - Roivant reported consolidated cash and marketable securities of $4.4 billion as of September 30, 2025, providing a strong cash runway [3][4] Financial Summary - Research and development expenses increased by $21.5 million to $164.6 million for Q2 2025, driven by program-specific costs and personnel-related expenses [7][9] - General and administrative expenses decreased by $59.8 million to $143.1 million for Q2 2025, primarily due to reduced personnel-related expenses [10][11] - Loss from continuing operations for Q2 2025 was $166.0 million, an improvement from $236.8 million in Q2 2024 [15][16] Upcoming Milestones - NDA filing for brepocitinib in dermatomyositis is planned for the first half of 2026, with topline data from ongoing trials expected in 2026 and 2027 [13][14] - Immunovant anticipates reporting results from several trials in 2026, including potentially registrational trials for IMVT-1402 [13][14] - Genevant's litigation continues with significant hearings expected in early 2026 [13][14]