Strong Phase II brepocitinib efficacy in cutaneous sarcoidosis
Placebo‑adjusted mean CSAMI improvement ~21.6 points (study was not powered for efficacy); 100% of patients on brepocitinib 45 mg achieved ≥10‑point CSAMI improvement; 62% of 45 mg patients achieved CSAMI <5 (functional remission); statistically significant separation vs placebo as early as Week 4 and sustained through Week 16.
Favorable safety and large existing brepocitinib database
No serious adverse events in the Phase II CS study; all adverse events were mild or moderate and safety was consistent with the compound's broader database of >1,500 patients, supporting a potentially favorable benefit‑risk profile.
Pipeline and registrational momentum
NDA for brepocitinib in dermatomyositis submitted; NIU Phase III pivotal readout expected in H2 2026; company to initiate a Phase III in cutaneous sarcoidosis this year; management cites 9+ pivotal study readouts across the portfolio in the coming years.
Enrollment achievements and upcoming catalysts
IMVT‑1402 (D2T RA) Phase IIb fully enrolled with 170 patients (up from an anticipated 120, a +41.7% increase in enrollment vs plan); mosliciguat PH‑ILD Phase II fully enrolled; top‑line data for mosliciguat and D2T RA expected in the second half of 2026.
Strong cash position to fund development
Consolidated cash balance of $4.5 billion provides runway for ongoing and planned registrational programs; company retains share buyback authorization.
Immunovant FcRn franchise progress
IMVT‑1402 highlighted as a potential best‑in‑class FcRn program with convenient subcutaneous administration; pivotal data in Graves' disease expected in 2027, supporting future commercial opportunity.
Favorable pretrial legal development
Received a favorable summary judgment decision on Section 1498 ahead of the Moderna jury trial (trial scheduled to begin March 9), which management views as constructive to their litigation posture.
Consistent patient‑reported outcome improvements
Multiple PROs (Skindex‑16, KSQ skin domain, Patient Global Impression of Change) showed substantial improvement for brepocitinib arms, with 100% of 45 mg patients reporting improvement on PGIC—supporting physician‑reported findings.