May. 29 at 11:10 AM
$IMVT Immunovant reports Q4 EPS (64c), consensus (72c)
In April 2025, Immunovant announced changes to its leadership team as part of a broader strategic transition with Roivant increasing operational involvement and oversight of Immunovant. Eric Venker, M.D. was appointed as CEO of Immunovant, and Tiago Girao as CFO of Immunovant. Given the strength of its potential best-in-class profile, IMVT-1402 is being developed in six announced indications, including potentially registrational trials in Graves' disease, difficult-to-treat rheumatoid arthritis, myasthenia gravis, chronic inflammatory demyelinating polyneuropathy and Sjogren's disease, and a proof-of-concept trial in cutaneous lupus erythematosus.
In March 2025, Immunovant announced positive results from its batoclimab MG and CIDP studies. The potentially registrational study in MG met its primary endpoint of change from baseline in Myasthenia Gravis Activities of Daily Living score in the AChR+ population at week 12, with the higher dose arm achieving a 5.6-point improvement and the lower dose arm achieving a 4.7-point improvement. Initial results from week 12 of the Phase 2b CIDP study demonstrated a mean improvement in the adjusted Inflammatory Neuropathy Cause and Treatment disability score of 1.8 across batoclimab arms and an 84% responder rate in those patients who achieved an IgG lowering greater than 70%.
In both batoclimab studies, deeper IgG reductions correlated with improved clinical outcomes across a range of assessments and timepoints. Potentially registrational trials for IMVT-1402 in both MG and CIDP are actively enrolling. In March 2025, Immunovant initiated a potentially registrational trial of IMVT-1402 in adult participants with active, anti-citrullinated protein autoantibody positive D2T RA and a proof-of-concept study in CLE.
Both indications represent potential first-in-class and best-in-class opportunities based on positive in-class competitor data and promising efficacy data from patients dosed with IMVT-1402 as part of an open-label case study program. Immunovant plans to initiate a potentially registrational trial evaluating IMVT-1402 in SjD and a second potentially registrational trial in GD in the summer of 2025. Immunovant expects to report batoclimab six-month remission data from the proof-of-concept study in GD in the summer of 2025 and Phase 3 thyroid eye disease data in the second half of calendar year 2025.
