Strong IMVT-1402 (FcRn) Open-Label RA Results (Period 1)
Preliminary open-label data from the 1402 DTRA study showed high response rates in a heavily refractory RA population: ACR20 ~73%, ACR50 >50%, ACR70 >33%. Study enrolled ~165 evaluable patients with high baseline disease activity (DAS28-CRP ~6.1).
Efficacy Preserved in JAK- and TNF-Refractory Subset
Subset analysis (107 JAK-experienced patients; most also TNF-experienced) demonstrated that the strong ACR responses were largely preserved in this difficult-to-treat population, supporting differentiation vs. existing options.
Clean Safety Profile Reported for 1402
Across the 1402 program (hundreds of patients dosed across studies), investigators reported the drug was well tolerated with no new safety signals identified; DMC has observed no meaningful LDL changes across the program.
Mosliciguat (mosli) Early Clinical Activity and Phase II Enrollment
Mosli showed robust hemodynamic activity in Phase I: single-dose mean PVR reduction >30% with peak ~38%, mean reductions in mPAP/NPAT up to ~20% and cardiac output increases up to ~25%. Phase II FOCUS fully enrolled with 135 patients; >95% of participants achieved the 4 mg target dose during titration. Topline PVR results expected in H2 2026.
Brepocitinib Program Progress and Regulatory Recognition
Brepocitinib received Breakthrough Therapy designation in sarcoidosis, LPP indication announced and enrolling, and commercial preparations for a potential dermatomyositis (DM) launch are underway targeting a launch by end of September if FDA goes as expected.
Strong Financial Position and Major Settlement
Cash and cash equivalents of $4.3 billion as of 03/31 (pre-Moderna settlement), no debt. Announced a $2.25 billion settlement with Moderna, with a $950 million upfront payment expected in July, strengthening liquidity and optionality.
Clinical Execution and Rapid Enrollment Across Programs
Multiple programs showed rapid enrollment and operational execution: CLE fully enrolled (topline H2), mosli enrolled all patients within ~12 months, and the FcRn 1402 study enrolled a heavily pretreated population quickly—evidence of investigator and patient engagement.
Dermatomyositis (Brepo) Scientific and Commercial Momentum
Brepo Phase III data were published (NEJM noted for the Phase III), commercial build-out including payer engagement, specialty pharmacy partnerships, and patient outreach ongoing; addressable populations estimates of 200k–300k (multiple indications) highlighted.