Why Are Argenx Shares Trading Higher Today?

Argenx SE ARGX reported topline results from the ADHERE study evaluating Vyvgart Hytrulo (efgartigimod alfa and hyaluronidase-qvfc) in adults with chronic inflammatory demyelinating polyneuropathy (CIDP). 

CIDP is a neurological disorder involving progressive weakness and reduced arm and leg senses. It is caused by damage to the fat-based protective covering on nerves called the myelin sheath.

The study met its primary endpoint with a 61% reduction in the risk of relapse versus placebo with up to 48 weeks of treatment (p=0.000039). 

A 26% relapse rate in Vyvgart Hytrulo patients compared to 54% with placebo was identified at week 24, and a 34% versus 60% relapse rate for Vyvgart Hytrulo and placebo patients, respectively, was evident at week 48. 

In addition, 67% of all treated patients in open-label stage A achieved clinical improvement with up to 12 weeks of therapy, increasing to 78% when only considering patients who received at least four doses (number of doses needed to reach fully effective therapeutic exposure and IgG reduction). 

Vyvgart Hytrulo was well-tolerated with a safety profile consistent with prior clinical trials and the known profile of Vyvgart.

Argenx has an exclusive license agreement with Zai Lab Limited ZLAB for developing and commercializing Vyvgart and Vyvgart Hytrulo in Greater China. 

Through this agreement, Zai Lab recruited Chinese patients into the ADHERE trial.

William Blair writes that the encouraging tolerability profile and reduced administration burden (injection lasting 60 to 90 seconds compared to more than 2-hour injection [ScIg] or infusion requirements [IVIg]) suggest a highly competitive edge for early CIDP treatment lines.

The analyst also says the results reduce some risk for other ongoing programs, including those in ITP and pemphigus, with pivotal data from these programs anticipated later this year.

Price Action: ARGX shares are up 27.10% at $480.98, and ZLAB stock is up 7.72% at $30.00 during the premarket session on the last check Monday.