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Biotech Stocks Facing FDA Decision In June 2024

argenx SE
argenx SE

The FDA decision on the expanded use of argenx SE’s (ARGX) Vyvgart Hytrulo in the proposed indication of chronic inflammatory demyelinating polyneuropathy in adults is due on June 21, 2024.

Vyvgart Hytrulo is a subcutaneous combination of efgartigimod alfa, a human IgG1 antibody fragment sold as VYVGART, and recombinant human hyaluronidase PH20 (rHuPH20), Halozyme’s ENHANZE technology to enable the subcutaneous delivery of biologics.

The FDA has already approved Vyvgart Hytrulo for the treatment of generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AChR) antibody positive.

ARGX closed Wednesday’s trading at $377.77, up 3.12%.