Argenx's (ARGX) Vyvgart Hytrulo is likely to get approval from the US Food and Drug Administration for adults with immune-mediated necrotizing myopathy and dermatomyositis, RBC Capital Markets analysts said in a note emailed Tuesday.
Analysts said that even if the FDA decides to play "hard ball" for dermatomyositis approval, a new larger trial is expected to be relatively straightforward.
RBC said that for immune-mediated necrotizing myopathy, commercial uptake could be very rapid, given that Vyvgart is the first drug to show benefits in phase 3 and neurologists are already familiar with it.
On dermatomyositis, analysts said that while the trial did not reach statistical significance, the Total Improvement Score benefit was consistent with immune-mediated necrotizing myopathy and phase 3 data outperformed phase 2.
RBC retained an outperform rating on the stock and increased its price target to $1,100 from $1,025.
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