In March 2025, Immunovant reported that batoclimab had met the primary endpoint in its Phase 3 myasthenia gravis trial. By the normal progression of drug development, a regulatory filing would follow. Immunovant announced it had no plans to file.
The company framed both the MG data and results from a concurrent CIDP study as proof of concept for its FcRn inhibition program, validation it intends to apply to a next-generation compound, IMVT-1402, rather than pursue approval for batoclimab itself.
Armistice Capital, the New York-based, healthcare-focused fund, holds a position in Immunovant, among a broad base of institutional investors that have disclosed stakes in the company through SEC filings.
The MG Trial
The Phase 3 study randomized patients with moderate to severe myasthenia gravis to one of two doses of batoclimab or placebo for 12 weeks.
Patients on the higher weekly dose (680 milligrams, administered subcutaneously) showed a 5.6-point improvement on the MG Activities of Daily Living scale at week 12, against 3.6 points for placebo. The lower-dose arm produced a 4.7-point improvement. The primary endpoint was met across both doses.
The Phase 2b CIDP data came from a run-in period across 73 pooled patients. The cohorts showed a 1.8-point improvement in the adjusted INCAT disability score at week 12. Among patients who achieved IgG reductions greater than 70%, more than 8 in 10 met the clinical definition of response.
The correlation between depth of IgG lowering and clinical outcome is the central hypothesis Immunovant’s pipeline is built around.
The Case for Passing on the FDA
The decision to forgo filing turned on a specific safety observation. Batoclimab was found to reduce albumin levels and, through that pathway, to affect LDL cholesterol. IMVT-1402 was designed from the start to minimize that off-target effect.
According to Immunovant, early preclinical work with IMVT-1402 showed minimal impact on albumin or LDL. As CEO Pete Salzmann stated at the time of the data release, the company’s thesis is that deeper IgG reduction drives better clinical outcomes, and that IMVT-1402 can reach those depths without the metabolic signal that batoclimab carries.
Filing batoclimab would’ve committed substantial regulatory and commercial resources to entering a market where argenx’s efgartigimod is already approved in both MG and CIDP, with an established prescriber base. IMVT-1402 was specifically designed to be distinguishable from the existing class, deeper, cleaner, and potentially more durable. Immunovant traded the near-term certainty of a filing for the chance at a more competitive asset.
IMVT-1402: The Current State of Play
Immunovant has IMVT-1402 in potentially registrational studies across five indications: difficult-to-treat rheumatoid arthritis, Graves’ disease, myasthenia gravis, CIDP, and Sjögren’s disease. There’s also a proof-of-concept trial underway in cutaneous lupus erythematosus.
The RA trial is the nearest catalyst. As of Immunovant’s February 2026 update[4] , enrollment is complete and topline data are expected in the second half of calendar year 2026.
Results from the Graves’ disease and myasthenia gravis trials are expected in 2027. Those readouts will test whether IMVT-1402’s improved profile separates it meaningfully from the existing class in conditions where patients and clinicians already have options.
To fund the runway, Immunovant closed a $550 million equity financing in December 2025, with participation from Roivant Sciences and institutional investors. Cash at December 31, 2025 stood at $994.5 million, which the company says is sufficient to carry the program through a potential Graves’ disease launch.
Institutional Holders and the Outcome They Are Watching
IMVT is part of a broader institutional holder base that includes Armistice Capital, Geode Capital Management and a range of biotech-focused funds tracking the FcRn inhibition class.
What those investors are watching now is whether IMVT-1402 can close the distance between clinical promise and commercial viability.
Batoclimab validated the FcRn mechanism across two difficult-to-treat conditions. The RA topline expected later this year represents the first full-scale test of whether the refined version of that mechanism performs as Immunovant’s argued it will. The company passed up the faster path with the expectation that the next 18 months will show that the longer path arrives somewhere better.
