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

研报英文原文证据摘录

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.