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argenx and Zai Lab Announce Approval of Efgartigimod Alfa Injection (Subcutaneous Injection) for Generalized Myasthenia Gravis in China
Newsfilter· 2024-07-16 04:30
First and only NMPA-approved subcutaneous injectable FcRn blocker for gMG patients in China Consistent clinical benefit and safety profile of efgartigimod SC compared to IV demonstrated in Phase 3 ADAPT-SC study July 16, 2024 6:30am CET Amsterdam, the Netherlands— argenx SE ((Euronext &amp, NASDAQ:ARGX) and Zai Lab Limited (NASDAQ:ZLAB, HKEX: 9688))) today announced that China's National Medical Products Administration (NMPA) approved the Biologics License Application (BLA) on July 16, 2024 for efgartigimo ...
argenx Highlights Breadth of Autoimmune Pipeline with New Multifocal Motor Neuropathy Data at 2024 Peripheral Nerve Society Annual Meeting
Newsfilter· 2024-06-25 20:30
ARDA study data show potential for empasiprubart to drive functional improvement and reduced risk of relapse for multifocal motor neuropathy (MMN) patients ADHERE+ data show durability of functional improvements with VYVGART® Hytrulo (efgartigimod alfa and hyaluronidase-qvfc), which is FDA approved for use in adults with chronic inflammatory demyelinating polyneuropathy (CIDP) June 25, 2024 – 4:30pm EDT Amsterdam, the Netherlands – argenx SE ((Euronext &amp, NASDAQ:ARGX), a global immunology company comm ...
argenx Highlights Breadth of Autoimmune Pipeline with New Multifocal Motor Neuropathy Data at 2024 Peripheral Nerve Society Annual Meeting
GlobeNewswire News Room· 2024-06-25 20:30
ARDA study data show potential for empasiprubart to drive functional improvement and reduced risk of relapse for multifocal motor neuropathy (MMN) patients ADHERE+ data show durability of functional improvements with VYVGART® Hytrulo (efgartigimod alfa and hyaluronidase-qvfc), which is FDA approved for use in adults with chronic inflammatory demyelinating polyneuropathy (CIDP) June 25, 2024 – 4:30pm EDT Amsterdam, the Netherlands – argenx SE (Euronext & Nasdaq: ARGX), a global immunology company committe ...
Argenx (ARGX) Surges 11.7%: Is This an Indication of Further Gains?
ZACKS· 2024-06-25 09:10
argenex SE (ARGX) shares soared 11.7% in the last trading session to close at $440.59. The move was backed by solid volume with far more shares changing hands than in a normal session. This compares to the stock's 7.5% gain over the past four weeks.The sudden rise in the stock price was observed after the company announced that the FDA approved its subcutaneously administered Vyvgart Hytrulo (efgartigimod) for a second indication — chronic inflammatory demyelinating polyneuropathy (CIDP). The drug has been ...
Why Is European Drugmaker Argenx Stock Trading Higher On Monday?
Benzinga· 2024-06-24 16:43
Loading...Loading...Friday, the FDA approved Argenx SE’s ARGX Vyvgart Hytrulo for use in patients with chronic inflammatory demyelinating polyneuropathy (CIDP).Vyvgart Hytrulo is approved for CIDP as a once-weekly 30-to-90-second subcutaneous injection. It is the first and only neonatal Fc receptor (FcRn) blocker approved for CIDP.CIDP is an autoimmune disorder in which the body’s immune system attacks the myelin that insulates and protects the body’s nerves. It causes muscle weakness, numbness, and other s ...
FDA Expands argenx's (ARGX) Vyvgart Label to Treat Rare Disorder
ZACKS· 2024-06-24 15:20
Shares of argenx (ARGX) rose nearly 4% on Friday after management announced that the FDA approved its subcutaneously administered Vyvgart Hytrulo (efgartigimod) for a second indication — chronic inflammatory demyelinating polyneuropathy (CIDP).Vyvgart Hytrulo has been approved as a once-weekly 30-to-90-second subcutaneous injection to treat adult patients with CIDP, a rare autoimmune disease. Per argenx, the approval ofVyvgart Hytrulo makes it the first FDA-approved medication with a novel mechanism of acti ...
argenx Announces FDA Approval of VYVGART Hytrulo for Chronic Inflammatory Demyelinating Polyneuropathy
Newsfilter· 2024-06-21 20:50
VYVGART® Hytrulo is first and only neonatal Fc receptor (FcRn) blocker approved to treat chronic inflammatory demyelinating polyneuropathy (CIDP) First novel, precision mechanism of action in more than 30 years for patients with CIDP Third approved indication for VYVGART® and VYVGART Hytrulo franchise Management to host conference call on June 21, 2024 at 11:00pm CET (5:00pm ET) June 21, 2024, 4:40pm ET   Amsterdam, the Netherlands – argenx SE ((Euronext &amp, NASDAQ:ARGX), a global immunology company comm ...
argenx Announces FDA Approval of VYVGART Hytrulo for Chronic Inflammatory Demyelinating Polyneuropathy
GlobeNewswire News Room· 2024-06-21 20:50
VYVGART® Hytrulo is first and only neonatal Fc receptor (FcRn) blocker approved to treat chronic inflammatory demyelinating polyneuropathy (CIDP) First novel, precision mechanism of action in more than 30 years for patients with CIDP Third approved indication for VYVGART® and VYVGART Hytrulo franchise Management to host conference call on June 21, 2024 at 11:00pm CET (5:00pm ET) June 21, 2024, 4:40pm ET   Amsterdam, the Netherlands – argenx SE (Euronext & Nasdaq: ARGX), a global immunology company committe ...
argenx to unveil its 'Vision 2030: Taking Breakthrough Science to 50,000 Patients' during its Upcoming R&D Day on July 16, 2024
Newsfilter· 2024-06-17 05:00
R&D Day presentations to include recent Phase 2 datasets in Sjogren's disease (efgartigimod) and multifocal motor neuropathy (empasiprubart) that support advancement to Phase 3 development Next wave of innovative pipeline candidates to be introduced highlighting long-term commitment to transform autoimmunity Decision to not advance development of efgartigimod in PC-POTS based on Phase 2 ALPHA data June 17, 2024, 7:00 AM CET Amsterdam, the Netherlands – argenx SE ((Euronext &amp, NASDAQ:ARGX), a global im ...
argenx to unveil its ‘Vision 2030: Taking Breakthrough Science to 50,000 Patients' during its Upcoming R&D Day on July 16, 2024
GlobeNewswire News Room· 2024-06-17 05:00
R&D Day presentations to include recent Phase 2 datasets in Sjogren’s disease (efgartigimod) and multifocal motor neuropathy (empasiprubart) that support advancement to Phase 3 development Next wave of innovative pipeline candidates to be introduced highlighting long-term commitment to transform autoimmunity Decision to not advance development of efgartigimod in PC-POTS based on Phase 2 ALPHA data June 17, 2024, 7:00 AM CET Amsterdam, the Netherlands – argenx SE (Euronext & Nasdaq: ARGX), a global immuno ...