argenx Submits Biologics License Application to U.S. Food and Drug Administration for Subcutaneous Efgartigimod for Treatment of Generalized Myasthenia Gravis
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
Submission package based on positive data from the Phase 3 ADAPT-SC trial demonstrating noninferiority of subcutaneous (SC) efgartigimod compared to intravenously administered VYVGART® (efgartigimod alfa-fcab) based on total immunoglobulin G (IgG) reduction at day 29 Amsterdam, the Netherlands – September 21, 2022 – argenx SE (Euronext & Nasdaq: ARGX), a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases, today announced the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for SC efgartigimod (1000mg efgartigimod-PH20) for the treatment of generalized myasthenia gravis (gMG) in adult patients. SC efgartigimod is co-formulated with recombinant human hyaluronidase PH20 (rHuPH20), Halozyme's ENHANZE® drug delivery technology. ENHANZE facilitates the subcutaneous injection delivery of biologics that are typically administered via intravenous (IV) infusion. “Our vision for the
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News
- 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