IRON Heating Up

研报英文原文证据摘录

IRON Heating Up

TD low major responders, and 75% of patients who completed

the study proceeding to optional continuation. nTD and TD low major responders

achieved clinically significant FACIT-Fatigue improvements that correlated with

Hgb change, and MPN-SAF TSS50 at end of study was achieved by 50% of nTD

and TD low major responders (Figure 6). Selcodebart was well-tolerated with

no early withdrawals due to AEs, and all serious and grade ≥3 AEs considered

unrelated to treatment (Figure 7). Additional data from RALLY-MF are expected

in 4Q26, with an end-of-phase 2 meeting with the FDA anticipated by year-end

and pivotal initiation in 1H27. We view the identical robust major response rates

on and off JAKi background therapy as an encouraging finding given that most

MF patients are already receiving JAKi treatment. In total, management estimates

a ~22K addressable population in the US, implying a >$4B opportunity. We also

see limited competition from other development programs, as activin ligand

traps (luspatercept, elritercept) are primarily focused on high-transfusion-burden

patients on ruxolitinib, a relatively narrow slice of the MF anemia population. CALR-

directed antibodies address roughly 25-30% of MF but concentrate their effect

in the platelet compartment, potentially creating opportunities for combination

approaches. Beyond anemia of MF, IRON is exploring selcodebart in additional

anemia indications, having initiated a Ph 2 study in anemia of IBD in 1Q26, with

initial data expected in 2027. The company also continues to conduct IND-enabling

activities for DISC-0998, its long-acting anti-HJV mAb.

Updated HELIOS OLE data (November 1, 2025 data cutoff) for bitopertin in

erythropoietic protoporphyria (EPP) showed sustained protoporphyrin IX (PPIX)