# argenx Phase 3 ALKIVIA Data Show 15.4-Point Myositis Improvement Over Placebo > argenx's Phase 3 ALKIVIA trial showed efgartigimod improved myositis scores by 15.4 points versus placebo. - Published: 2026-11-07T15:25:54+00:00 - Section: Research & Clinical Trials - Author: News Desk - URL: https://newsforagent.com/news/2026-11-07/argenx-alkivia-myositis-phase-3-data - Source: [Stock Titan](https://www.stocktitan.net/news/ARGX/argenx-presents-phase-3-alkivia-data-at-acr-convergence-2026-showing-8whjr4sme9tt.html) ## Key takeaways - Efgartigimod improved mean Total Improvement Score by 15.4 points versus placebo at Week 52 in the combined IMNM and DM population (48.0 vs 32.6; p=0.0011). - The IMNM cohort showed a 14.8-point greater improvement in mean TIS versus placebo (45.1 vs 30.2; p=0.0048). - argenx plans to submit a Supplemental Biologics License Application to the FDA for efgartigimod in IMNM by the end of 2026. - The DM cohort showed a 14.5-point greater improvement versus placebo (51.5 vs 37.0; p=0.1093) but did not reach statistical significance. [argenx](https://akta.pro/company-profiles/0000beg/argenx) reported that its Phase 3 ALKIVIA study met its primary endpoint, with efgartigimod producing a 15.4-point greater improvement in mean Total Improvement Score at Week 52 versus placebo in patients with autoimmune myositis. [Stock Titan](https://www.stocktitan.net/news/ARGX/argenx-presents-phase-3-alkivia-data-at-acr-convergence-2026-showing-8whjr4sme9tt.html) published the company's announcement on November 7, 2026. ## How the ALKIVIA Trial Performed In the combined immune-mediated necrotizing myopathy (IMNM) and dermatomyositis (DM) population, patients on efgartigimod reached a mean TIS of 48.0 versus 32.6 for placebo (p=0.0011). The study also met key secondary endpoints in the combined population, including response rate, time to response, muscle strength and disease activity. Efgartigimod was generally well tolerated, with a safety profile consistent with prior studies. In the IMNM cohort, efgartigimod showed a 14.8-point greater improvement in mean TIS versus placebo at Week 52 (45.1 vs 30.2; p=0.0048). Patients on efgartigimod were twice as likely to maintain a TIS of 40 or more through Week 52, and creatine kinase levels fell with a 43.5 percentage-point greater reduction from baseline versus placebo. In the smaller DM cohort, efgartigimod showed a 14.5-point greater improvement versus placebo in mean TIS at Week 52 (51.5 vs 37.0; p=0.1093), though statistical significance was not reached. Skin disease severity improved by 5.6 points more than placebo at Week 52 as measured by CDASI. "These Phase 3 results add to the growing body of evidence that targeting FcRn delivers a meaningful, sustained benefit for people with autoimmune myositis," said Luc Truyen, M.D., Ph.D., Chief Medical Officer, argenx. ALKIVIA randomized 265 patients across IMNM, DM and polymyositis, with 175 patients receiving treatment in the Phase 3 portion. [Zai Lab](https://akta.pro/company-profiles/0002ccc/zai-lab) holds an exclusive license from argenx for VYVGART and VYVGART Hytrulo in Greater China and recruited Chinese patients into the trial. ## argenx's Commercial Scale Behind the Program According to [akta.pro company records](https://akta.pro/company-data), argenx reported $4.2 billion in full-year 2025 global product net sales, representing 90% year-over-year growth, and $1.1 billion in operating income, its first year of operating profitability. The company, founded in 2008 and headquartered in Boston, commercializes VYVGART, the first approved FcRn blocker, for generalized myasthenia gravis and CIDP. ## Earlier argenx Milestones In October 2026, argenx reported positive topline Phase 3 ALKIVIA results, meeting the primary endpoint with clinically meaningful improvement over placebo in both the IMNM and dermatomyositis groups, according to Yahoo. In May 2026, the FDA expanded VYVGART and VYVGART Hytrulo approval to all adult gMG serotypes, according to akta.pro records. In February 2026, argenx reported positive Phase 3 ADAPT OCULUS topline results with a 4.04-point MGII PRO ocular improvement at Week 4 (p=0.012), the same records show. ## What Comes Next for Efgartigimod argenx plans to submit a Supplemental Biologics License Application to the FDA for efgartigimod in IMNM by the end of 2026, supported by a Breakthrough Therapy Designation. The ALKIVIA data will be presented in a late-breaking oral presentation at ACR Convergence 2026 on November 11, 2026. ## Companies in this story - [argenx company profile](https://akta.pro/company-profiles/0000beg/argenx) · website: https://www.argenx.com - [Zai Lab company profile](https://akta.pro/company-profiles/0002ccc/zai-lab) · website: https://zailaboratory.com --- News for Agent · https://newsforagent.com/llms.txt