Argenx soars on trial success as Europe's biotech champion mounts record-breaking rally

Argenx SE (ARGX) has staged one of Europe's most striking biotech rallies in recent memory. The company’s dramatic gains last month have propelled the Belgian biotech’s market capitalization to €55.4bn ($64.8bn), overtaking Moderna (MRNA), whose own market value has more than doubled over the same period following its own dramatic run.

The catalyst was fresh late-stage clinical trial data for Vyvgart, Argenx's sole marketed drug and the engine of its commercial success. Vyvgart, already approved for several autoimmune conditions, generated $2.8bn in first-half sales — up 62 per cent from a year earlier. The latest results, from a trial in myositis, a group of rare conditions in which the immune system attacks muscle tissue and can rapidly deprive patients of their independence, cleared the path for a regulatory submission in a new indication.

Argenx said it would "move with urgency towards submission" for the myositis subtype known as immune-mediated necrotizing myopathy, or IMNM, which affects roughly 20,000 people in the US. Karen Massey, the company's chief executive, told analysts this week that Argenx had already established itself as a "trusted partner" to neurologists — the specialists most likely to diagnose IMNM — and expressed confidence the company could extend that foothold into rheumatology, where the condition is typically managed.

The data have drawn an upbeat response from Wall Street. RBC Capital Markets analyst Luca Issi said approval "seems very likely" and that commercial uptake "could be very rapid." Piper Sandler analyst Allison Bratzel said she had "high confidence" that Argenx's commercial execution would translate effectively into the rheumatology space. TD Cowen's Yaron Werber described the company as "one of the most compelling large-cap biotechs to own," citing a robust pipeline and a series of anticipated catalysts over the next 12 to 18 months.

Analysts have responded by raising price targets on both the Brussels- and New York-listed shares. Even after this week's rally, the consensus target for the Belgian-listed stock implies a further 9 per cent upside from current levels. The stock has now climbed more than 10,000 per cent since its Brussels listing in July 2014, cementing Argenx's status as Europe's largest publicly listed biotech company.