GLOBAL RESEARCH ARCHIVE
ROIV, IMVT -1Q CY26; Promising IMVT-1402 Preliminary ACR Results in D2T R2A; CLE Ph2, NIU Ph3 and PH-ILD Ph2 Data on Track for 2H26
Research evidence excerpt
ROIV, IMVT -1Q CY26; Promising IMVT-1402 Preliminary ACR Results in D2T R2A; CLE Ph2, NIU Ph3 and PH-ILD Ph2 Data on Track for 2H26
Biotechnology May 22, 2026
Yatin Suneja
yatin.suneja@guggenheimpartners.com ROIV, IMVT -1Q CY26; Promising IMVT-1402
212 518 9565 Preliminary ACR Results in D2T R2A; CLE Ph2, NIU Delma Caiati, M.D., Ph.D.
delma.caiati@guggenheimpartners.com Ph3 and PH-ILD Ph2 Data on Track for 2H26
617 859 4606
Iris Gao, Ph.D. Key Message: Key takeaways from ROIV/IMVT 1QCY26 (4QFY25) earnings: (1) iris.gao@guggenheimpartners.com
212 518 9013 IMVT-1402 (FcRn inhibitor) 600 mg QW SC treatment delivered promising ACR20/50/70
response rates of 72.7%, 54.5% and 35.8% at Week 16 in the open-label Period 1
Eddie Hickman, Ph.D. (n=165) of the D2T RA study (Exhibit 1). Notably, 99.4% of patients failed ≥1 cDMARD
eddie.hickman@guggenheimpartners.com and ≥2 MoAs of b/tsDMARDs (Exhibit 2). In comparison, JNJ's nipocalimab+TNFi 212 518 9904
combination reported ACR20/50/70 response rates of ~62%, 40% and 14% at Week
Min Lee, Ph.D. 12. ROIV delineated ACR responses in JAKi and TNFi-experienced patients (n=107),
min.lee@guggenheimpartners.com which were consistent with the overall population (Exhibit 3). While these initial efficacy
212 823 6744 results are open-label, we find them —especially ACR70 responses —highly
encouraging and unlikely to be placebo effects alone, which could derisk '1402
across multiple autoimmune studies (Exhibit 5). The next key readout is from CLE
Phase II in 2H26. (2) Pulmovant completed enrollment of mosliciguat's (sGC activator)
Phase II study (n=135; Exhibit 4) in PH-ILD, with topline data on track for 2H26.
Blinded safety reviews appear favorable with >95% subjects reaching max dose during
titration.
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