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argenx VYVGART Phase 3 results lift shares to record high
In its ALKIVIA Phase 3 study, efgartigimod showed a 15.4-point mean Total Improvement Score advantage over placebo at Week 52, with benefits holding even after steroid tapering.
argenx SE and Zai Lab Limited announced positive topline results from an ALKIVIA Phase 3 study evaluating VYVGART Hytrulo, and the data boosted market expectations for the therapy in adults with autoimmune myositis, Yahoo Finance reports.
In the combined immune-mediated necrotizing myopathy (IMNM) and dermatomyositis (DM) population, efgartigimod (efgartigimod) delivered a statistically significant 15.4-point greater improvement in mean Total Improvement Score versus placebo at Week 52. The improvements began by Week 4 and were sustained through steroid tapering.
For IMNM, the primary endpoint was met with a 14.8-point improvement over placebo. In DM, the smaller cohort showed a 14.5-point benefit, but statistical significance was missed.
Market reaction followed the Aug. 17 announcement, with William Blair noting the results increased confidence in Vyvgart's path in DM and sending argenx shares up 15% to an all-time high. The same day, RBC Capital raised its price target on argenx to $1,100 from $1,025, citing the IMNM data and projecting faster commercial uptake tied to an estimated 20,000 U.S. patient population.