logo
  

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.

For comments and feedback contact: editorial@rttnews.com

Business News

Editors Pick
Ride-hailing company Lyft announced its foray into the media and advertisement business with the launch of Lyft Media as part of its vision to build the world's largest transportation media network. Lyft Media has built a suite of new products to allow advertisers to engage with Lyft's growing audience throughout their transportation journeys. Sysco Corp. (SYY) Tuesday reported a more than a three-times surge in fourth-quarter earnings, supported by 17.5 percent growth in sales. The company projects fiscal 2023 adjusted earnings to grow. Earnings for the quarter spiked to $509.99 million from $151.09 million last year. On a per share basis,... Longmont Colorado -based Royal Crest Dairy is recalling 2% Chocolate Milk citing the potential to be contaminated with undeclared egg, a known allergen, the U.S. Food and Drug Administration said. The recall involves Farmer's 2% Reduced Fat Chocolate Milk Pints with the code date of AUG-22.
RELATED NEWS
Follow RTT