argenx

argenx SE operates as a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases. It operates from the Netherlands, Belgium, the United States of America, Japan, Switzerland, Germany and France. The firm partnering with academic researchers through its Immunology Innovation Program (IIP), argenx aims to translate immunology breakthroughs into a world-class portfolio of novel antibody-based medicines. It evaluates efgartigimod in multiple serious autoimmune diseases and advancing several earlier stage experimental medicines within its therapeutic franchises. The company was founded by Hans J. W. de Haard, Torsten Dreier, and Tim van Hauwermeiren in 2008 and is headquartered in Breda, the Netherlands.

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argenx SE is a global immunology company, which engages in improving the lives of people suffering from severe autoimmune diseases. It operates through the following geographical segments: United States, Japan, EMEA, and China. The company was founded by Hans J. W. de Haard, Torsten Dreier, and Tim van Hauwermeiren in 2008 and is headquartered in Amsterdam, the Netherlands.

Argenx dived after its antibody therapy for an autoimmune disease that causes skin blisters failed to beat a placebo in a phase 3 trial.

Argenx Dives On Autoimmune Therapy Failure

Argenx stock ARGX, -33.70% ARGX, -0.64% lost a third of its value as the Amsterdam biotech said a late-stage trial did not meet primary or secondary endpoints. The Phase 3 study was of using efgartigimod subcutaneous in adults with pemphigus vulgaris and pemphigus foliaceus.

Argenx stock dives by a third after late-stage trial didn't meet goals

ADDRESS study did not meet primary or secondary endpoints Pemphigus deprioritized as efgartigimod indication Update on BALLAD study GO/NO GO decision Conference call scheduled for today, December 20, 2023, at 8:30am ET (2:30pm CET) Regulated Information – Inside Information December 20, 2023, 7:00am 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 topline results from the ADDRESS study evaluating efgartigimod subcutaneous (SC) (efgartigimod alfa and hyaluronidase-qvfc) in adults with pemphigus vulgaris (PV) and pemphigus foliaceus (PF). The ADDRESS results show the proportion of PV patients achieving the primary endpoint of complete remission on a minimal dose of steroids (CRmin) was not significantly different between efgartigimod SC and placebo.

argenx Reports Topline Results from ADDRESS Study of Efgartigimod SC in Pemphigus

Argenx stock plummeted Tuesday after the company's drug unexpectedly failed to help patients with a rare blood disorder.

Argenx Stock Crashes On An Unexpected Failure For Its Biggest Drug

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Regulated information – Inside information

argenx Reports Topline Results from ADVANCE-SC Study of VYVGART Hytrulo in Primary Immune Thrombocytopenia

VYVGART® is now approved for both intravenous (IV) and self-administered subcutaneous (SC) use in Europe argenx is committed to continued collaboration with local authorities across the region to enable broad access to VYVGART SC for eligible patients Amsterdam, The Netherlands— November 16, 2023 —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 European Commission (EC) approved SC injectable VYVGART (efgartigimod alfa) as an add-on to standard therapy for the treatment of generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AChR) antibody positive. The EC previously approved VYVGART IV in August 2022.

argenx Announces European Commission Approval of Subcutaneous VYVGART® (efgartigimod alfa) for Generalized Myasthenia Gravis

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Long-term clinical trial and real-world data illustrate VYVGART® drives consistent, repeatable and clinically meaningful responses, including minimal symptom expression (MSE) in generalized myasthenia gravis (gMG)

argenx Highlights Data Evaluating VYVGART in Neuromuscular Autoimmune Disease at AANEM and MGFA Scientific Sessions

argenx SE (NASDAQ:ARGX ) Q3 2023 Earnings Conference Call October 31, 2023 8:30 AM ET Company Participants Beth DelGiacco - VP and Global Head, Corporate Communications and IR Tim Van Hauwermeiren - CEO Karl Gubitz - CFO Karen Massey - COO Conference Call Participants Yatin Suneja - Guggenheim Partners Tazeen Ahmad - Bank of America Derek Archila - Wells Fargo Thomas Smith - Leerink Partners James Gordon - JPMorgan Amy Li - Jefferies Danielle Brill - Raymond James Yaron Werber - TD Cowen Myles Minter - William Blair Joel Beatty - Baird Alex Thompson - Stiefel Allison Bratzel - Piper Sandler Vikram Purohit - Morgan Stanley Manos Mastorakis - Deutsche Bank Douglas Tsao - H.C. Wainwright Joon Lee - Truist Securities Suzanne van Voorthuizen - VLK Samantha Semenkow - Citi Rajan Sharma - Goldman Sachs Charles Pitman - Barclays Operator Good morning.

argenx SE (ARGX) Q3 2023 Earnings Call Transcript

Argenx reported better-than-expected sales of its autoimmune disease drug, Vyvgart, and posted narrow losses. The biotech stock popped.

Argenx Comes Up With Big Sales Beat, Narrower-Than-Expected Losses

$329 million in third quarter global net product sales On track to submit VYVGART® Hytrulo sBLA for CIDP by year-end 2023 Results from the ADVANCE-IV study published in The Lancet Management to host conference call today at 1:30 pm CET (8:30 am ET) October 31, 2023 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 its third quarter 2023 financial results and provided a business update and outlook for the remainder of the year. “We continue to prioritize patient impact with VYVGART and VYVGART Hytrulo, broadening our two gMG products into earlier treatment lines and new geographies.

argenx Reports Third Quarter 2023 Financial Results and Provides Business Update

October 24, 2023 Amsterdam, the Netherlands – argenx (Euronext & Nasdaq: ARGX), a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases, today announced that it will host a conference call and audio webcast on Tuesday, October 31, 2023 at 1:30 pm CET (8:30 am ET) to discuss its third quarter 2023 financial results and provide a business update.

argenx to Report Third Quarter 2023 Financial Results and Business Update on October 31, 2023

argenx exhibits robust financials with a Q2 YoY net sales surge to $269.3M and liquidity of $2.0B but faces increasing operating costs and R&D expenditures. Efgartigimod, ARGX's primary asset, shows high revenue potential but faces competition from IMVT-1402 and other emerging therapeutics in the autoimmune space. Investment recommendation: "Buy" with caution. Monitor the competitive landscape and consider a diversified strategy to mitigate inherent market risks.

argenx: Efgartigimod Is Not Just A Drug, A Cornerstone

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Immunovant Parlays Its Shot At Rivaling Argenx Into A $300 Million Offering

The stock gapped up nearly 28% on July 17, after announcing better-than-expected results from a clinical trial of its treatment for patients suffering from a progressive condition that affects muscle control.

Argenx's 28% Surge & Promising Product Propel Investor Confidence

Amsterdam, The Netherlands — Sep. 2 1 , 2023—argenx SE (Euronext & Nasdaq: ARGX), a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases, today announced that Health Canada has issued a Notice of Compliance authorizing VYVGARTⓇ (efgartigimod alfa) for the treatment of generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AChR) antibody positive. With this regulatory milestone, VYVGART is the first-and-only neonatal Fc receptor (FcRn) blocker authorized for sale in Canada.

argenx Announces VYVGART (efgartigimod alfa) Authorized for Sale by Health Canada for Generalized Myasthenia Gravis

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Amsterdam, The Netherlands— September 15 , 2023 —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 Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended EC approval of the SC injectable formulation of efgartigimod as an add on to standard therapy for the treatment of adult patients with generalized myasthenia gravis (gMG) who are anti acetylcholine receptor (AChR) antibody positive. SC efgartigimod is formulated with Halozyme's ENHANZE® drug delivery technology to facilitate subcutaneous delivery of biologics.

argenx Announces Positive CHMP Opinion for Subcutaneous Efgartigimod for Generalized Myasthenia Gravis

Shares of argenx surged after positive phase 3 results for efgartigimod in CIDP patients, reaching new all-time highs. Vyvgart's net sales exceeded $1 billion in Q2, with the majority of sales coming from the United States. FDA approval of Vyvgart Hytrulo for gMG patients should expand the market and lead to improved uptake.

argenx: Three Important Milestones Reached In 2023, More To Come

Argenx recently reported positive news from a clinical trial for its lead medicine. The company could be looking at many more approvals for this therapy.

Is Argenx Stock a Buy Now?

argenx SE (NASDAQ:ARGX ) Q2 2023 Earnings Conference Call July 27, 2023 8:30 AM ET Company Participants Beth DelGiacco - VP and Global Head, Corporate Communications & IR Tim Van Hauwermeiren - CEO & Executive Director Karl Gubitz - CFO Karen Massey - COO Conference Call Participants Tazeen Ahmad - Bank of America Merrill Lynch Derek Archila - Wells Fargo Securities Yaron Werber - TD Cowen Danielle Brill - Raymond James & Associates Amy Li - Jefferies Xian Deng - UBS Joon Lee - Truist Securities Samantha Semenkow - Citigroup Rajan Sharma - Goldman Sachs Group Douglas Tsao - H.C. Wainwright & Co. Allison Bratzel - Piper Sandler & Co. Joel Beatty - Robert W.

argenx SE (ARGX) Q2 2023 Earnings Call Transcript

$269 million in second quarter VYVGART® (efgartigimod alfa-fcab) global net product sales VYVGART® Hytrulo now available in the U.S. with first vials shipped in July Global VYVGART expansion continued with commercial launch in Italy and distribution agreement with Handok in South Korea Topline results from ADVANCE-SC and ADDRESS expected in fourth quarter of 2023 Management to host conference call today at 2:30 pm CET (8:30 am ET) July 27 , 202 3 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 its half year 2023 financial results and provided a second quarter business update. “We are thrilled to see the momentum continue across all aspects of our business, with a catalyst-rich first half of the year.

argenx Reports Half Year 2023 Financial Results and Provides Second Quarter Business Update

Argenx is up around 40% in 2023 after shares soared nearly 30% in a single day last week. Meanwhile, analysts forecast sales skyrocketing 200%.

Argenx Stock Rides 'Megabuster' Drug Excitement To 40% Gain Before Earnings

Regulated information – Inside i nformation July 24, 2023, 4 : 30 PM ET July 24, 2023, 10 : 30 PM 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, announced today the closing of its previously announced global offering of an aggregate of 2,581,633 ordinary shares, which may be represented by American Depositary Shares (“ADSs”) and which includes full exercise of the underwriters' option to purchase 336,734 additional ordinary shares in the form of ADSs. The gross proceeds from the global offering were approximately $1.27 billion (approximately €1.13 billion).

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