Argenx SE (NASDAQ:ARGX) stock has faced pressure after the company disclosed changes to the analysis plan for its ongoing Phase 3 Vyvgart study in myositis.
However, H.C. Wainwright said they remain encouraged by the drug’s prospects, particularly in immune-mediated necrotizing myopathy (IMNM), which they believe could eventually generate more than $1 billion in sales.
Analyst Meeting Reveals Changes To Phase 3 Myositis Program
Citing a recent analyst meeting, analyst Douglas Tsao said Argenx’s Phase 3 readout for Vyvgart in myositis will now include separate analyses for the IMNM and dermatomyositis (DM) cohorts on the study’s primary endpoint.
The company also disclosed that it is no longer pursuing polymyositis (PM). According to HC Wainwright, PM had the lowest enrollment among the myositis subtypes, making it difficult to identify a clear treatment signal.
The revised strategy prompted some pressure on Argenx shares as investors assessed the implications of the changes.
Analyst Tsao wrote that, “update wasn’t altogether that surprising to us, since we’d known that IMNM had the strongest signal in the POC study, which drove the high level of statistical significance, and resulted in BTD from FDA.”
HC Waunwright maintains the Buy rating on Argenx and price forecast of $940.
Analysts See Encouraging Signs In Dermatomyositis
Despite the market reaction, HC Wainwright said it came away from the meeting with a more favorable view of Vyvgart’s prospects in dermatomyositis.
The firm noted that Argenx’s tone regarding the opportunity in DM appeared more optimistic than in recent communications, particularly following Roivant Sciences Ltd.’s (NASDAQ:ROIV) announcement of Phase 3 data for brepocitinib in the VALOR trial.
HC Wainwright interpreted the company’s comments as a sign that management continues to see meaningful potential for Vyvgart in the indication.
ARGX Price Action: Argenx shares were up 4.72% at $892.70 at the time of publication on Thursday. The stock is approaching its 52-week high of $934.61, according to Benzinga Pro data.
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