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Zai Lab, argenx report 15.4-point ALKIVIA improvement
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Zai Lab, argenx report 15.4-point ALKIVIA improvement

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  • Zai Lab and argenx said VYVGART Hytrulo produced a 15.4-point greater mean TIS improvement than placebo at Week 52.
  • Zai Lab shares were down about 0.3% at $25.90 in the latest available pre-market trade.
  • The companies said benefits appeared by Week 4 and persisted through one year despite protocol-mandated steroid tapering.

Zai Lab (NASDAQ:ZLAB) and argenx (NASDAQ:ARGX) reported that VYVGART Hytrulo met the Phase 3 ALKIVIA primary endpoint with a 15.4-point TIS advantage over placebo at Week 52.

Patients with combined IMNM and dermatomyositis recorded mean TIS scores of 47.95 with efgartigimod versus 32.56 with placebo, with statistical significance at p=0.0011.

Prespecified analysis showed a 14.8-point advantage in IMNM at p=0.0048, while DM showed a 14.5-point numerical benefit that did not reach statistical significance at p=0.1093.

Zai Lab and argenx said detailed results will be presented at an upcoming medical meeting.

Following the announcement, Zai Lab's share price was down 0.3% at $25.90 in the latest available pre-market trade.

Zai Lab holds Greater China development and commercialization rights to VYVGART and VYVGART Hytrulo and recruited Chinese patients into the global ALKIVIA study.

Zai Lab reported second-quarter 2026 revenue of $106.3 million and recently launched KarXT in mainland China while advancing additional immunology and oncology programs.

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