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Argenx Stock Up On Positive CHMP Opinion For Efgartigimod For GMG Patients In Europe

Dutch immunology company argenx SE (ARGX) announced Friday that efgartigimod has received positive opinion from the Committee for Medicinal Products for Human Use or CHMP of the European Medicines Agency for the treatment of adult patients with Generalized Myasthenia Gravis or gMG in Europe.

Argenx shares were gaining more than 3 percent in Europe trading, and more than 1 percent in the pre-market activity on Nasdaq.

The company noted that CHMP has recommended European Commission approval of efgartigimod as an add-on to standard therapy for the treatment of adult patients with generalized gMG who are anti-acetylcholine receptor or AChR antibody positive.

The positive opinion is based on Phase 3 ADAPT trial showing efgartigimod provided clinically meaningful improvements in strength and quality of life measures.

The EC is expected to make a decision on marketing authorization application within approximately 60 days following CHMP recommendation. The approval will be applicable to all 27 European Union Member States, in addition to Iceland, Norway and Liechtenstein.

The positive CHMP opinion is a scientific recommendation for marketing authorization, serving as a basis for the EC's final decision on argenx's application for efgartigimod.

Efgartigimod is the first-and-only approved FcRn blocker in the U.S. as VYVGART (efgartigimod alfa-fcab) for the treatment of adult gMG patients who are anti-AChR antibody positive and in Japan for those who do not have sufficient response to steroids or non-steroidal immunosuppressive therapies (ISTs).

argenx also plans to launch efgartigimod in Canada, China through its collaboration with Zai Lab, and select additional regions.

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