ARGENX SE (ARGX) Form 6-K — Nov 9, 2026
argenx reported that its Phase 3 ALKIVIA study met its primary and key secondary endpoints, with efgartigimod showing a statistically significant 15.4-point greater improvement in Total Improvement Score versus placebo in the combined IMNM and DM autoimmune myositis population at Week 52. The IMNM subgroup showed a clinically meaningful 14.8-point TIS improvement (p=0.0048), supporting efgartigimod as a potential first-ever approved therapy for IMNM, which affects roughly 20,000 U.S. patients and has no approved treatments. argenx plans to submit an sBLA to the FDA for IMNM by end of 2026 under a Breakthrough Therapy Designation.
Key figures
- Us dm patients
- 40000
- Phase3 patients
- 175
- Us imnm patients
- 20000
- Dm tis improvement
- 14.5-point greater vs placebo (51.5 vs 37.0, p=0.1093, not significant)
- Patients randomized
- 265
- Imnm tis improvement
- 14.8-point greater vs placebo (45.1 vs 30.2, p=0.0048)
- Us myositis patients
- 100000
- Combined imnm dm tis improvement
- 15.4-point greater vs placebo (48.0 vs 32.6, p=0.0011)
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