argenx Announces FDA Acceptance of Supplemental Biologics License Application with Priority Review for VYVGART Hytrulo in Chronic Inflammatory Demyelinating Polyneuropathy
argenx SE - American Depositary Shares (ARGX)
US:NASDAQ Investor Relations:
investor.argenx.com/phoenix.zhtml?c=254223&p=irol-presentations
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Source: GlobeNewswire
Prescription Drug User Fee Act (PDUFA) target action date is June 21, 2024 If approved, VYVGART® Hytrulo will be the first neonatal Fc receptor (FcRn) blocker to treat CIDP February 20, 2024, 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 Hytrulo (efgartigimod alfa and hyaluronidase-qvfc) for the treatment of chronic inflammatory demyelinating polyneuropathy (CIDP). The application has been granted a PDUFA target action date of June 21, 2024. “Today’s announcement brings us one step closer to delivering the transformative innovation of VYVGART Hytrulo to CIDP patients,” said Luc Truyen, Chief Medical Officer of argenx. “CIDP is yet another example of an autoimmune disease that
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- argenx SE (NASDAQ: ARGX) had its "outperform" rating re-affirmed by analysts at Wedbush. They now have a $521.00 price target on the stock.MarketBeat
- argenx SE (NASDAQ: ARGX) had its "buy" rating re-affirmed by analysts at HC Wainwright. They now have a $451.00 price target on the stock.MarketBeat
- argenx Data Highlight Evidence that VYVGART and VYVGART Hytrulo Drive Transformative Outcomes for Patients with Debilitating Autoimmune DiseaseGlobeNewswire
- Here's Why argenx SE (ARGX) Pulled Back 23% in Q4 [Yahoo! Finance]Yahoo! Finance
- argenx SE (NASDAQ: ARGX) had its "buy" rating re-affirmed by analysts at HC Wainwright. They now have a $451.00 price target on the stock.MarketBeat
ARGX
Earnings
- 2/29/24 - Miss
ARGX
Sec Filings
- 4/16/24 - Form 6-K
- 3/27/24 - Form 6-K
- 3/27/24 - Form 6-K
- ARGX's page on the SEC website