Argenx Gets European Commission Approval For Drug To Treat Rare Autoimmune Disease, But Stock Fails To Garner Retail Attention

VYVGART for SC injection is available in vials or prefilled syringes and can be administered by a patient, caregiver, or healthcare professional.

Nasdaq-listed shares of argenx SE (ARGX) rose 2% by Friday afternoon after the company announced that the European Commission approved its VYVGART 1,000 mg subcutaneous (SC) injection in the treatment of adult patients with progressive or relapsing active chronic inflammatory demyelinating polyneuropathy (CIDP).

CIDP is a rare and often progressive autoimmune disease of the peripheral nervous system. Patients with CIPD experience a range of mobility and sensory issues, including trouble standing from a seated position, pain and fatigue, and frequent tripping or falling.

The European Commission approved the subcutaneous injection as a monotherapy for patients with the disease who have received prior treatment with corticosteroids or immunoglobulins.

The EC approval will apply to all 27 European Union Member States, as well as to Iceland, Liechtenstein, and Norway.

VYVGART for SC injection is available as a vial or prefilled syringe and can be administered by a patient, caregiver, or healthcare professional. The company stated that it is “working closely” with local regulatory authorities to ensure patients can access the treatment as soon as possible.

The approval is based on a clinical trial that demonstrated 66.5% of patients treated with VYVGART SC showed evidence of clinical improvement, including improvements in mobility, function, and strength. The study also revealed a 61% reduction in the risk of relapse compared to the placebo.

This regulatory approval marks the second for VYVGART SC in Europe, which first received approval as an add-on to standard therapy for the treatment of adult patients with generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) antibody positive.

On Stocktwits, retail sentiment around argenx remained within ‘bullish’ territory over the past 24 hours while message volume remained ‘normal’.

ARGX stock is down by 12% this year but has gained over 40% in the past 12 months.

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