Dashboard/IMVT/batoclimab/event

ReadoutTopline Readout↗ date slipped

Batoclimab gMG Phase 3 Topline

IMVT·batoclimab·Myasthenia Gravis·

Phase 3

·NCT05425927

current best date

SEP

2026

MONTH4 months

Takeaway

Phase 3 efficacy readout for batoclimab in generalized myasthenia gravis (gMG). Approved competitor in the FcRn class: argenx VYVGART. Watch: MG-ADL change at week 12, dosing convenience (subq vs. IV), LDL elevation profile.

What’s at stake

market · comparables · base rate · prior moves

Market opportunity

—

company filings

Peer comparables

2 readouts

ClinicalTrials.gov

Stage base rate

~58%

BIO Industry Analysis 2023 (2011–2020)

Avg prior-readout move

—

historical price reactions

Batoclimab is a subcutaneous monoclonal antibody developed by Immunovant that blocks the neonatal Fc receptor (FcRn) — a protein in blood vessel walls that recycles immunoglobulin G (IgG) antibodies back into circulation. In autoimmune diseases driven by pathogenic IgG antibodies, blocking FcRn prevents this recycling, accelerating the breakdown of harmful antibodies and reducing disease activity. Batoclimab is in Phase 3 trials for generalized myasthenia gravis; a known class effect of FcRn inhibitors — including the approved competitor VYVGART (efgartigimod) — is LDL cholesterol elevation, which is monitored as a safety endpoint across all batoclimab trials.

Indication

Immunology

Myasthenia Gravis

MeSH · D009157

IgG-driven autoimmune disorder where antibodies attack neuromuscular junction receptors, causing fluctuating muscle weakness. Affects ~80,000 patients in the US.

Trial

active

NCT05425927 ↗

Phase 3 Batoclimab in gMG

Glossary · what this readout is measuring

3 terms detected in the takeaway

gMGdisease
Generalized Myasthenia Gravis
IgG-driven autoimmune disorder where antibodies attack neuromuscular junction receptors, causing fluctuating muscle weakness. Affects ~80,000 patients in the US.
FcRntarget
Neonatal Fc Receptor
A salvage receptor that recycles IgG. Inhibiting it forces IgG degradation, lowering pathogenic antibody levels in autoimmune disease.
MG-ADLendpoint
Myasthenia Gravis Activities of Daily Living
An 8-item, patient-reported scale (0-24) tracking daily-life impact of myasthenia gravis. Lower scores = less disability. A 2-point reduction is considered clinically meaningful.

Reference data · comparable readouts

How Ph3 readouts in Immunology have landed.

Reference, not prediction. We surface the historical record so you can read it yourself. We never extrapolate to the upcoming event.

Positive

0/0

0% in record

Primary endpoint hit

across 0 readouts

Drug · sponsorPhase · yearOutcomeKey metricSource

litifilimab

BIIB · CLE

Ph2 · Sep 2022positiveCLASI-A 38% reductionPR

rocatinlimab

KYME · Atopic dermatitis

Ph2 · Aug 2022positiveEASI-75 56% vs 22% pboPR

sorted by phase match, then recency · sources span PR wires, CT.gov, FDA notices, and conference presentations · we never editorialize the outcome label

Competitive landscape

3 peers in Immunology · ranked by indication + modality match

Drug	Company	Modality	Mechanism	Next catalyst
DUPIXENTdupilumab	REGN	mAb	IL-4Rα blocker	READOUT · Jan 27
NTLA-2002	NTLA	gene therapy	in vivo CRISPR knockout of KLKB1	ENROLLMENT · Sep 26
ORLADEYOberotralstat	BCRX	small molecule	plasma kallikrein inhibitor	CMC · Jun 26

Disclosure trail

2 observations · sorted by confidence

Apr 15, 2026·15d agopinned · highest confidence
HIGH conf8-K
top claim
SEP2026
MONTH↗ 62dvs prior
“Topline data from the Phase 3 study of batoclimab in generalized myasthenia gravis is now expected in September 2026.”
conf 91%via llm
Mar 28, 2026·1mo ago
HIGH conf8-K
other claim
Q3'26
QTR
“We continue to expect topline gMG Phase 3 data in the third quarter of 2026.”
conf 86%via llm

MethodologyEvery catalyst date is anchored to a primary source. Disclosures with confidence ≥ 0.85 auto-publish; the rest are reviewed by a human within 24 hours. We never interpret data — we organize public information.