# Argenx: Vyvgart Hytrulo meets primary endpoint in Phase 3 ALKIVIA myositis trial

- Published: 2026-11-07 17:41 UTC
- Section: Life & Health › Medicine
- Tags: Argenx, Vyvgart Hytrulo, efgartigimod, ALKIVIA trial, autoimmune myositis, immune-mediated necrotizing myopathy, dermatomyositis, Total Improvement Score, sBLA FDA, ACR Convergence
- URL: https://realtech.media/news/rt-c5027a3d2e09367b7ac48005_argenx_vyvgart_hytrulo/

**In the Phase 3 ALKIVIA trial, efgartigimod improved the Total Improvement Score by 15.4 points over placebo at 52 weeks; the result was significant in IMNM but not in dermatomyositis.**

![Argenx: Vyvgart Hytrulo meets primary endpoint in Phase 3 ALKIVIA myositis trial](https://realtech.media/media/2026/11/21f1725a36cab1bc.webp)
*ad-hoc-news.de*

Argenx reported that the Phase 3 ALKIVIA trial of Vyvgart Hytrulo in autoimmune myositis met its primary endpoint, according to ad-hoc-news.de. [1] In the combined population of immune-mediated necrotizing myopathy (IMNM) and dermatomyositis (DM), patients treated with efgartigimod improved by 15.4 points more than those on placebo on the Total Improvement Score after 52 weeks (p=0.0011). [1] Key secondary endpoints were also met: response rate, time to response, muscle strength and disease activity. [1]

The safety profile was consistent with earlier studies. [1] The trial included 265 randomized patients, and 175 were treated in the Phase 3 stage. [1]

## Results by subgroup

Analyzed separately, the two conditions differ. In IMNM, the advantage over placebo was 14.8 points and statistically significant (p=0.0048). [1] Creatine kinase, a marker of muscle damage, fell by 43.5 percentage points more than in the placebo group. [1]

In dermatomyositis, the gap to placebo was similar at 14.5 points, but the group did not reach statistical significance (p=0.1093). [1] The company points to the smaller cohort and to improvements in muscle strength and skin findings that appeared from week 4. [1] The result is therefore mixed: clear in IMNM, unresolved in DM.

## Regulatory plans and next data

Argenx intends to focus on IMNM for now while continuing development in DM. [1] In the USA, about 20,000 patients are diagnosed with IMNM and about 40,000 with DM. [1] The article notes that no approved therapy exists for the subgroup where the data are most pronounced. [1]

The company plans to submit a supplemental biologics license application (sBLA) for IMNM to the US FDA by the end of 2026. [1] An existing special FDA designation for the program supports the filing. [1]

Full data will be presented on 11 November in a late-breaking talk at the ACR Convergence rheumatology congress. [1] Details on subgroups and tolerability are expected there. [1]

## Sources

1. [ad-hoc-news.de](https://www.ad-hoc-news.de/boerse/news/unternehmensnachrichten/argen-x-aktie-myositis-studie-trifft-ziel/70475128)

---

Source: RealTech, realtech.media — https://realtech.media/news/rt-c5027a3d2e09367b7ac48005_argenx_vyvgart_hytrulo/