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 ...

Core Insights - Argenx SE presented new data on empasiprubart and VYVGART® Hytrulo at the 2024 Peripheral Nerve Society Annual Meeting, highlighting their potential to improve treatment outcomes for patients with multifocal motor neuropathy (MMN) and chronic inflammatory demyelinating polyneuropathy (CIDP) [2][3] Group 1: Empasiprubart for MMN - The Phase 2 ARDA study data supports empasiprubart as a novel treatment option for MMN, showing a 91% reduction in the risk of IVIg retreatment compared to placebo [4][10] - Empasiprubart demonstrated improvements in grip and muscle strength, enhancing patients' ability to perform daily activities [4] - The treatment was well-tolerated, with most adverse events being mild or moderate [4][13] Group 2: VYVGART Hytrulo for CIDP - VYVGART Hytrulo received FDA approval on June 21, 2024, as a safe and effective treatment for CIDP, showing a 61% reduction in the risk of relapse compared to placebo [5][7] - The ADHERE trial demonstrated sustained functional benefits across all disease scores, with 99% of participants opting for the open-label extension study [5][6] - Patients treated with VYVGART Hytrulo maintained functional improvements, while placebo patients experienced clinically meaningful worsening [6][7] Group 3: Company Overview - Argenx is focused on developing innovative therapies for severe autoimmune diseases, aiming to transform treatment outcomes and reduce the risk of relapse and disability [3][23] - The company is advancing a pipeline of antibody-based medicines, including empasiprubart and VYVGART Hytrulo, to address unmet medical needs in MMN and CIDP [3][23]

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 ...

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 ...

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 ...

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 ...

Core Insights - The FDA has approved VYVGART Hytrulo as the first and only neonatal Fc receptor (FcRn) blocker for treating chronic inflammatory demyelinating polyneuropathy (CIDP), marking a significant advancement in treatment options for this condition [2][3][5] - VYVGART Hytrulo represents the first novel mechanism of action for CIDP in over 30 years, providing a new therapeutic option for patients who have been waiting for innovative treatments [3][4] - The approval is based on the ADHERE Study, which demonstrated that 69% of patients treated with VYVGART Hytrulo showed clinical improvement, with a 61% reduction in the risk of relapse compared to placebo [5][16] Company Overview - Argenx SE is a global immunology company focused on developing treatments for severe autoimmune diseases, with a commitment to improving patient lives [2][19] - The company has developed VYVGART Hytrulo, which combines efgartigimod alfa and hyaluronidase-qvfc, facilitating subcutaneous injection delivery of biologics [17] - Argenx is also evaluating efgartigimod in multiple serious autoimmune diseases and advancing several earlier-stage experimental medicines [19] Treatment Context - CIDP is a rare and debilitating autoimmune disease affecting the peripheral nervous system, with significant impacts on patients' mobility and quality of life [3][18] - Current treatment options have been limited to corticosteroids and plasma-derived therapies, which can be burdensome for patients [5][4] - The introduction of VYVGART Hytrulo provides a new, safe, and effective treatment option that may alleviate some of the treatment burdens faced by CIDP patients [5][4] Clinical Study Insights - The ADHERE trial was the largest clinical trial to date for CIDP, enrolling 322 adult patients and demonstrating significant clinical benefits from VYVGART Hytrulo [5][16] - The trial's primary endpoint was met with a statistically significant reduction in relapse risk, affirming the efficacy of VYVGART Hytrulo in treating CIDP [5][16] Patient Access and Support - VYVGART Hytrulo is expected to be available for patients in the U.S. immediately, with a patient support program, My VYVGART Path, established to assist with access and education [7][19] - The annual out-of-pocket cost for patients is expected to be comparable to existing treatments for CIDP and generalized myasthenia gravis [7]

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 ...

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 ...

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 ...