Halozyme Therapeutics Inc (HALO)

[Fred Kadiddlehopper]

Argenx updates on SC efgartigimod
https://ih.advfn.com/stock-market/NASDAQ/argenx-ARGX/stock-news/89930889/argenx-highlights-2023-strategic-priorities-across

Reach More Patients with VYVGART
argenx is planning for multi-dimensional expansion to reach more patients with VYVGART, its first-in-class neonatal Fc receptor blocker. This includes generalized myasthenia gravis (gMG) patients through regulatory approvals in new regions and the launch of its subcutaneous (SC) product offering, as well as a new autoimmune indication with the VYVGART regulatory submission for ITP in Japan.

Prescription Drug User Fee Act (PDUFA) target action date of March 20, 2023, for U.S. Food and Drug Administration approval decision on SC efgartigimod for gMG
Regulatory approval decision on SC efgartigimod for gMG expected in EU in fourth quarter of 2023
Submission for marketing approval of SC efgartigimod for gMG expected in Japan in first quarter of 2023
Regulatory approval decisions of VYVGART for gMG expected in Canada in third quarter of 2023 and in China and Israel by end of 2023
gMG launch in France, United Kingdom and Italy expected by year-end 2023 following review of respective reimbursement dossiers
Submission for Japan marketing approval of VYVGART for ITP expected in mid-2023