argenx Announces FDA Acceptance of Supplemental Biologics License Application with Priority Review for VYVGART in AChR-Ab Seronegative gMG
argenx SE - American Depositary Shares (ARGX)
US:NASDAQ Investor Relations:
investor.argenx.com/phoenix.zhtml?c=254223&p=irol-presentations
Company Research
Source: GlobeNewswire
January 13, 2026, 7:00 AM CET Amsterdam, the Netherlands – argenx SE (Euronext & Nasdaq: ARGX), a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases, today announced that the U.S. Food and Drug Administration (FDA) has accepted for priority review a supplemental Biologics License Application (sBLA) for VYVGART® (IV: efgartigimod alfa-fcab) for the treatment of adults with acetylcholine receptor antibody (AChR-Ab) seronegative generalized myasthenia gravis (gMG). The application has been granted a Prescription Drug User Fee Act (PDUFA) target action date of May 10, 2026. “Patients living with seronegative gMG continue to face limited treatment options and there remains a significant need to meaningfully improve their lives. The FDA’s acceptance of our sBLA with Priority Review status reflects the potential of VYVGART to address this need,” said Luc Truyen, M.D., Ph.D., Chief Medical Officer, argenx. “This development brings
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News
- argenx Highlights 2026 Strategic PrioritiesGlobeNewswire
- argenex (NASDAQ:ARGX) had its price target lowered by analysts at Citigroup Inc. from $1,124.00 to $1,091.00. They now have a "buy" rating on the stock.MarketBeat
- argenex (NASDAQ:ARGX) had its price target raised by analysts at Truist Financial Corporation from $950.00 to $1,030.00. They now have a "buy" rating on the stock.MarketBeat
- argenx to Present at 44th Annual J.P. Morgan Healthcare ConferenceGlobeNewswire
- argenx Announces Leadership Transition Marking Next Evolution of GrowthGlobeNewswire
ARGX
Earnings
- 10/30/25 - Beat
ARGX
Sec Filings
- 1/13/26 - Form 6-K
- 1/12/26 - Form 6-K
- 1/5/26 - Form 6-K
- ARGX's page on the SEC website