Roivant’s Brepocitinib Delivers Δ21.6 CSAMI-A Boost; Q3 Loss Narrows to $0.24
Roivant’s brepocitinib 45 mg achieved a 22.3-point mean improvement in CSAMI-A at Week 16 versus 0.7 for placebo (Δ21.6; P<0.0001), prompting a planned Phase 3 start in 2026 and an NDA filing in dermatomyositis. The company reported a Q3 loss of $0.24 per share versus a $0.27 expected loss and held $4.5 billion in cash and equivalents.
1. Positive Phase 2 CS Results
The BEACON trial randomized 31 cutaneous sarcoidosis patients to brepocitinib 45 mg, 15 mg or placebo over 16 weeks. Brepocitinib 45 mg patients achieved a 22.3-point mean CSAMI-A improvement versus 0.7 for placebo (Δ21.6; P<0.0001) with 100% meeting ≥10-point reduction and 62% reaching functional remission (CSAMI-A<5).
2. Pipeline Progress and Regulatory Plans
Following FDA engagement, Roivant will advance brepocitinib in CS into a pivotal Phase 3 program in 2026. An NDA for dermatomyositis has been submitted, and Phase 3 readouts for non-infectious uveitis plus Phase 2 topline data for other indications are expected in H2 2026.
3. Q3 Financial Results and Cash Position
Roivant reported a GAAP loss of $0.24 per share for the quarter ended December 31, 2025, versus a $0.27 per-share loss consensus. The company held $4.5 billion in cash, cash equivalents and marketable securities, supporting its cash runway into profitability.