Strong Phase II efficacy in cutaneous sarcoidosis (brepocitinib)
Proof-of-concept, randomized (3:2:2) 16-week study (n=31) showed robust efficacy for brepocitinib 45 mg vs placebo with a placebo-adjusted CSAMI improvement of ~21.6 points (statistically significant). Key outcomes: 100% of patients on brepo 45 mg achieved ≥10-point CSAMI improvement (MCID = 5 points), 62% achieved CSAMI <5 (functional remission), separation from placebo observed as early as Week 4 and maintained through Week 16, consistent improvements on multiple PROs (Skindex-16, KSQ skin domain, patient global impression) and safety with no SAEs and only mild/moderate AEs.
Pipeline and regulatory progress for brepocitinib
Multiple registrational programs in motion: NDA submitted for dermatomyositis, active pivotal programs in NIU and dermatomyositis, Phase III planned to start this year for cutaneous sarcoidosis, and management cites 9+ pivotal readouts expected across programs — positioning brepocitinib as a multi-indication asset across high-unmet-need orphan inflammatory diseases.
Clinical enrollment momentum across portfolio
Several trials are fully enrolled or upsized: IMVT‑1402 DTRA study enrolled 170 patients (upsized from 120, +41.7%), D2T RA and the PH‑ILD (mosli/mostly) studies are fully enrolled — accelerating the timeline for multiple readouts expected later in 2026 and 2027.
Favorable safety profile supported by broader database
Cutaneous sarcoidosis study reported no SAEs and only mild/moderate AEs; company references an overall brepocitinib safety database of >1,500 patients supporting a potentially favorable benefit–risk profile for the indications pursued.
Strong cash position and runway
Consolidated cash of $4.5 billion provides substantial capital to fund ongoing and planned clinical programs and near-term commercial activities; company retains share buyback authorization.
Legal procedural win ahead of trial
Favorable summary judgment ruling on Section 1498 in the Moderna litigation was obtained ahead of the March 9 jury trial, improving aspects of Roivant's asserted case coverage for the litigation.