美国生物科技：Roivant和Immunovant - 2027财年第一季度后模型更新

研报英文原文证据摘录

20 August 2026

US Biotechnology

Roivant and Immunovant - Post 1Q27 Model Update

Jeffrey Walch, MD, Ph.D.

Wen Jiang, Ph.D., CFA

Specialist Sales

Christian Moore

For ROIV and IMVT, everything remains on track. The primary incremental update was

brepocitinib Ph3 in CS, where first patients have now been enrolled, and topline data is

expected in 2028.

For ROIV, a notable new disclosure was the design of the Phase 3 BEACON+ trial in

CS. The study's primary endpoint is CSAMI-A ≥50% improvement at Week 16, an

endpoint that management indicated demonstrated a meaningfully large effect size

(>50%) in Ph2. While ROIV did not provide the exact Ph2 responder rate, management

stated that well over 50% of treated patients achieved CSAMI-A ≥50% improvement, vs.

0% on placebo, supporting confidence in the powering assumptions for Ph3. The totality

of the Ph2 CS data strongly corroborates the meaningful effect size: The study population

had a mean CSAMI-A of 33.6 at baseline (Exhibit 2). 45 mg brepo reduced CSAMI-A by a

mean of 21.6 relative to pbo at 16 weeks (-22.2 by brepo vs -0.7 by pbo), well exceeding

50% reduction (Exhibit 3). 100% of 45mg brepo patients achieved over 10-point CSAMI-A

reduction (vs. 14% in the pbo arm); 62% of 45mg brepo patients achieved CSAMI-A <5 (vs.

0% in the pbo arm) (Exhibit 4).

Roivant is entering a catalyst-rich 2H26: PH-ILD Ph2 readout, NIU Ph3 readout,

CLE Ph2 readout, D2T RA update on period 2 data and regulatory interactions,

DM launch by Sept, and an external catalyst from argenx’s Ph3 IIM topline (argenx

covered by Justin Smith). We continue to think PH-ILD Ph2 readout and NIU Ph3 readout

are the reasons to own ROIV. For PH-ILD, management didn’t specify a numerical MCID

bar for 6MWD, but emphasized the importance of having an approvable drug. For NIU,

management highlighted the variability in placebo response rates in immunology trials is

significant, which might be the biggest risk of the Ph3 NIU trial. Nevertheless, management

expressed confidence with the Ph3 given strong Ph2.

What’s changed in our modeling: For ROIV, we reflect brepocitinib launch and sales to

commence in 2028 vs earlier assumption in 2027.…