argenx reports 15.4-point gain in ALKIVIA trial
- argenx said its Phase 3 ALKIVIA trial met its primary endpoint, with efgartigimod delivering a 15.4-point greater mean TIS improvement than placebo.
- argenx shares were up 8.2% at $920.98 in pre-market trading following the clinical trial announcement.
- argenx plans to present detailed ALKIVIA data at an upcoming medical meeting while continuing efgartigimod development across additional autoimmune diseases.
argenx (NASDAQ:ARGX) reported that subcutaneous VYVGART Hytrulo met the Phase 3 ALKIVIA primary endpoint, producing a 15.4-point greater mean Total Improvement Score than placebo at Week 52.
The combined IMNM and dermatomyositis group recorded mean TIS scores of 47.95 with efgartigimod and 32.56 with placebo, with benefits appearing by Week 4 despite required steroid tapering.
Prespecified analysis showed a 14.8-point TIS advantage in IMNM at Week 52, while DM showed a 14.5-point numerical improvement that did not reach statistical significance.
argenx said detailed ALKIVIA results will be presented at an upcoming medical meeting.
Following the announcement, argenx's share price was up 8.2% at $920.98 in pre-market trading.
Meanwhile, argenx reported $1.5 billion in second-quarter product net sales, launched VYVGART across all U.S. gMG serotypes and outlined plans to pursue an ocular myasthenia gravis label expansion.
argenx also agreed in July to acquire Forte Biosciences for approximately $2.2 billion and began its $77-per-share tender offer on August 6 to expand its immunology pipeline.
