ARGX

argenx SE American Depositary Shares Nasdaq Global Select
$317
Open: $315.41 High: $320.54 Low: $310.66 Close: $316.65
Range: 2021-06-23 - 2021-06-24
Volume: 132,196
Market: Open
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ARGX
argenx SE American Depositary Shares Willemstraat 5 Breda , 4811 http://www.argenx.com
argenx SE, along with its subsidiaries is engaged in the bio-technical research on drugs and pharma processes for the treatment of oncological, autoimmune and inflammatory diseases.
  • CEO: Tim Van Hauwermeiren
  • Employees: 73
  • Sector: Healthcare
  • Industry: Biotechnology
ARGX News
Latest news about the ARGX
  • Argenx's drug effective against muscle-weakening disease myasthenia gravis

    An experimental drug developed by argenx SE led to improvements in daily activities, including chewing and swallowing, in patients suffering from a muscle-weakening autoimmune disease, according to data published in the Lancet Neurology medical journal on Wednesday. The late-stage study met its main goal of demonstrating that a greater percentage of patients on the treatment showed improvement in their daily activities compared to those on placebo. The study enrolled 167 participants to evaluate argenx's lead drug, efgartigimod, which seeks to reduce a type of disease-causing antibodies commonly found in patients with the chronic, rare autoimmune disorder called generalized myasthenia gravis.

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  • argenx announces publication of Phase 3 ADAPT trial results of efgartigimod for the treatment of generalized myasthenia gravis in The Lancet Neurology

    Results from ADAPT showed treatment with efgartigimod provided clinically meaningful improvements in strength and quality of life measures in generalized myasthenia gravis (gMG) Efgartigimod is under U.S. Food and Drug Administration (FDA) review with December 17, 2021 Prescription Drug User Fee Act (PDUFA) target action date Breda, the Netherlands —Jun. 16, 2021— argenx (Euronext & Nasdaq: ARGX), today announced that The Lancet Neurology has published pivotal trial results from the Phase 3 ADAP

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  • This Biotech Stock Has Big Potential

    The company's main selling point is a drug called efgartigimod, which the company is testing in six different diseases.

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  • Biotech Stock Roundup: BIIB's Drug Approval, ALXN Drug Label Expansion & More

    The biotech sector was in focus last week with regulatory updates from Biogen (BIIB) and bluebird (BLUE), among others.

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  • argenx (ARGX) to Regain AML Candidate After J&J's Dismissal

    argenx (ARGX) is developing cusatuzumab as potential treatment for acute myeloid leukemia. However, its partner, J&J, decided to discontinue the development agreement with the company for the candidate.

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  • Argenx to Regain Worldwide Rights to Cusatuzumab from Janssen

    Immunology company Argenx SE (ARGX) is regaining the global rights to its anti-CD70 antibody cusatuzumab from Janssen Pharmaceutical. Argenx and Jannsen had entered into a collaboration to develop custuzumab in 2018 and Argenx had received about $525 million from Janssen in the form of cash, equity investment, and milestone payments. On June 4, Janssen informed Argenx of its decision to discontinue the collaboration. Data from the Phase 1b ELEVATE trial of the drug support its development for tr

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  • argenx to regain global rights to cusatuzumab

    Regulated Information/Inside Information June 7, 2021 Breda, the Netherlands – argenx SE (Euronext & Nasdaq: ARGX), a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases and cancer, today announced it will regain worldwide rights to its anti-CD70 antibody cusatuzumab from Cilag GmbH International, one of the Janssen Pharmaceutical Companies of Johnson & Johnson. Interim data from the Phase 1b ELEVATE trial support continued development i

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  • argenx Appoints Karl Gubitz as Chief Financial Officer

    June 1, 2021Breda, the Netherlands – argenx (Euronext & Nasdaq: ARGX), a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases and cancer, today announced the appointment of Mr. Karl Gubitz as Chief Financial Officer. Mr. Gubitz brings to argenx nearly 20 years of global pharmaceutical leadership experience, specifically in financial planning and analysis, business partnerships and product commercialization. He will succeed Eric Castaldi, who will remain with the company through June 30, 2021. “We are delighted to welcome Karl to our executive leadership team as he has an impressive track record of successfully establishing commercial organizations and providing strategic financial direction for global biopharmaceutical companies,” said Tim Van Hauwermeiren, CEO of argenx. “Karl’s insight and financial expertise will make him an indispensable member of the team as we advance our vision of developing an integrated, innovative, global immunology organization that aims to impact the lives of patients.” “On behalf of the argenx management team and Board of Directors, we thank Eric for his significant contributions as we have grown from a private company to a near-commercial organization. It has been a pleasure working with him and we are grateful for the integral role he played in our growth and success over the last seven years. He will always be a part of the argenx family and we wish him well in all his future ventures,” added Mr. Van Hauwermeiren. Mr. Gubitz has nearly 20 years of experience as a senior finance professional in the pharmaceutical industry at Pfizer, where he most recently served as Vice President of Finance within the Global Oncology business. At Pfizer, he successfully negotiated the commercialization model for tanezumab with Eli Lilly in all non-U.S. markets as well as the Myovant co-commercialization agreement for Orgovyx™. Within Pfizer, Mr. Gubitz has held country, regional, and global positions, and consistently delivered top-line growth. He has managed teams of over 250 colleagues in roles such as Vice President of Finance in the Global Internal Medicine business and Vice President of Finance, North America in the Global Innovative Products business. Prior to joining Pfizer in 2003, Mr. Gubitz held various management roles at PricewaterhouseCoopers. Mr. Gubitz holds a Master of Business Administration from Henley Management College in the United Kingdom, a Bachelor of Computing from the University of South Africa, and a Bachelor of Commerce from the University of Pretoria. “This is a particularly exciting time to be joining argenx, as the Company nears the first potential commercial launch of its lead product, efgartigimod,” said Mr. Gubitz. “I look forward to working alongside this talented team as we transition to a commercial-stage company and grow argenx’s global immunology footprint to improve the lives of patients suffering from a variety of autoimmune diseases.” About argenx argenx is a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases and cancer. Partnering with leading academic researchers through its Immunology Innovation Program (IIP), argenx aims to translate immunology breakthroughs into a world-class portfolio of novel antibody-based medicines. argenx is evaluating efgartigimod in multiple serious autoimmune diseases, and cusatuzumab in hematological cancers in collaboration with Janssen. argenx is also advancing several earlier stage experimental medicines within its therapeutic franchises. argenx has offices in Belgium, the United States, Japan, and Switzerland. For more information, visit www.argenx.com and follow us on LinkedIn at https://www.linkedin.com/company/argenx/ and Twitter at https://twitter.com/argenxglobal. For further information, please contact: Media: Kelsey Kirkkkirk@argenx.com Joke Comijn jcomijn@argenx.com Investors: Beth DelGiaccobdelgiacco@argenx.com Michelle Greenblattmgreenblatt@argenx.com Forward-looking Statements The contents of this announcement include statements that are, or may be deemed to be, “forward-looking statements.” These forward-looking statements can be identified by the use of forward-looking terminology, including the terms “believes,” “estimates,” “anticipates,” “expects,” “intends,” “may,” “will,” or “should” and include statements argenx makes concerning its commercial readiness; its hope to reach patients this year; its statements regarding the therapeutic potential of Efgartigimod in patients; 2021 business and financial outlook and related plans; the therapeutic potential of its product candidates; the intended results of its strategy and argenx’s, and its collaboration partners’, advancement of, and anticipated clinical development, data readouts and regulatory milestones and plans, including the timing of planned clinical trials and expected data readouts; the design of future clinical trials and the timing and outcome of regulatory filings and regulatory approvals. By their nature, forward-looking statements involve risks and uncertainties and readers are cautioned that any such forward-looking statements are not guarantees of future performance. argenx’s actual results may differ materially from those predicted by the forward-looking statements as a result of various important factors, including the effects of the COVID-19 pandemic, argenx’s expectations regarding its the inherent uncertainties associated with competitive developments, preclinical and clinical trial and product development activities and regulatory approval requirements; argenx’s reliance on collaborations with third parties; estimating the commercial potential of argenx’s product candidates; argenx’s ability to obtain and maintain protection of intellectual property for its technologies and drugs; argenx’s limited operating history; and argenx’s ability to obtain additional funding for operations and to complete the development and commercialization of its product candidates. A further list and description of these risks, uncertainties and other risks can be found in argenx’s U.S. Securities and Exchange Commission (SEC) filings and reports, including in argenx’s most recent annual report on Form 20-F filed with the SEC as well as subsequent filings and reports filed by argenx with the SEC. Given these uncertainties, the reader is advised not to place any undue reliance on such forward-looking statements. These forward-looking statements speak only as of the date of publication of this document. argenx undertakes no obligation to publicly update or revise the information in this press release, including any forward-looking statements, except as may be required by law.

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  • argenx to Present at Upcoming Investor Conferences

    June 1, 2021Breda, the Netherlands – argenx (Euronext & Nasdaq: ARGX), a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases and cancer, today announced that members of management will participate in the following upcoming investor conferences: Goldman Sachs 42nd Annual Global Healthcare Conference. Fireside chat on Tuesday, June 8, 2021 at 2:10 p.m. ET.JMP Securities Life Sciences Conference. Fireside chat on Wednesday, June 16, 2021 at 11:00 a.m. ET.J.P. Morgan European Healthcare Conference. Management will participate in investor meetings on Thursday, June 17, 2021.Raymond James Human Health Innovation Conference. Management will participate in a panel discussion on Tuesday, June 22, 2021 at 12:00 p.m. ET. Additional information regarding these events will be available on the Company’s website at www.argenx.com. About argenxargenx is a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases and cancer. Partnering with leading academic researchers through its Immunology Innovation Program (IIP), argenx aims to translate immunology breakthroughs into a world-class portfolio of novel antibody-based medicines. argenx is evaluating efgartigimod in multiple serious autoimmune diseases, and cusatuzumab in hematological cancers in collaboration with Janssen. argenx is also advancing several earlier stage experimental medicines within its therapeutic franchises. argenx has offices in Belgium, the United States, Japan, and Switzerland. For more information, visit https://www.argenx.com/ and follow us on LinkedIn at https://www.linkedin.com/company/argenx/ and Twitter at https://twitter.com/argenxglobal. For further information, please contact: Media: Kelsey Kirkkkirk@argenx.com Joke Comijn jcomijn@argenx.com Investors: Beth DelGiaccobdelgiacco@argenx.com Michelle Greenblattmgreenblatt@argenx.com

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  • argenx SE (ARGX) Q1 2021 Earnings Call Transcript

    Image source: The Motley Fool. argenx SE (NASDAQ: ARGX)Q1 2021 Earnings CallMay 14, 2021, 1:30 p.m. ETContents: Prepared Remarks Questions and Answers Call Participants Prepared Remarks: OperatorGood morning and welcome to the Argenx First Quarter 2021 Earnings Call.

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  • argenx SE to Host Earnings Call

    NEW YORK, NY / ACCESSWIRE / May 14, 2021 / argenx SE (NASDAQ:ARGX) will be discussing their earnings results in their 2021 First Quarter Earnings call to be held on May 14, 2021 at 8:30 AM Eastern Time.To listen to the event live or access a replay of the call - visit https://www.

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  • argenx Reports First Quarter 2021 Financial Results and Provides Business Update

    Japanese Marketing Authorization Application (J-MAA) for efgartigimod accepted for review by Japan’s Pharmaceuticals and Medical Device Agency (PMDA) for generalized myasthenia gravis (gMG) Management to host conference call today at 2:30 pm CEST (8:30 am ET) May 14, 2021Breda, the Netherlands – argenx (Euronext & Nasdaq: ARGX), a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases and cancer, today reported financial results for the first quarter 2021 and provided a business update. “We’ve had a strong start to 2021 with the acceptance for review of the BLA and J-MAA for efgartigimod in gMG by the regulatory agencies in the U.S. and Japan. The submissions in China and the EU are on track and we are well-positioned for a global launch of our first-in-class FcRn antagonist. We are building an exceptional team with significant launch experience in neurology and rare disease and hope to reach patients this year,” said Tim Van Hauwermeiren, Chief Executive Officer of argenx. “Efgartigimod has the potential to help people living with gMG as well as several other severe autoimmune diseases mediated by IgG autoantibodies. Our team is advancing registrational trials across four indications with plans to start enrollment in two additional efgartigimod indications this year. We are also broadening our reach within autoimmunity with our first-in-class C2 inhibitor, ARGX-117, from which we will have Phase 1 data mid-year. To complement our clinical pipeline, we continue to invest in our discovery capabilities through our Immunology Innovation Program and strategic technology partnerships that position us well to generate long-term value for shareholders. We are closer each day to building an integrated, innovative, global immunology organization with the goal of impacting the lives of patients,” concluded Mr. Van Hauwermeiren. FIRST QUARTER 2021 AND RECENT BUSINESS UPDATE Commercial preparations on-track for global launch of IV efgartigimod for gMG, including regulatory submissions, initial salesforce hires and key stakeholder engagement efforts Biologics License Application (BLA) for IV efgartigimod for treatment of gMG accepted for review by U.S. Food and Drug Administration (FDA) with target action date of December 17, 2021 under Prescription Drug User Fee Act (PDUFA)J-MAA submitted to Japan’s PMDA and accepted for review with anticipated Japan commercial launch in 2022MAA expected to be filed with European Medicines Agency (EMA) in second half of 2021Zai Lab Limited to discuss potential accelerated regulatory pathway for approval in China with National Medical Products Administration (NMPA)Commercial readiness activities on-track, including: Continued build-out of global commercial organization, including hiring of U.S. regional business directors during first quarterLaunched pre-approval access (PAA) program in March 2021 in U.S., Canada and Europe to open availability of efgartigimod to people living with gMG who meet the pre-approval access program criteria Immunology pipeline advancing with five ongoing registrational trials of efgartigimod and initial upcoming data from second potential pipeline-in a product candidate, ARGX-117 Enrollment ongoing in five registrational trials across four indications, including ADAPT-SC (gMG), ADHERE (chronic inflammatory demyelinating polyneuropathy or CIDP), ADVANCE and ADVANCE-SC (primary immune thrombocytopenia or ITP), and ADDRESS (pemphigus) Go-forward decision confirmed in February 2021 in ADHERE trial evaluating subcutaneous (SC) efgartigimod in CIDP based on evaluation of interim safety and efficacy assessments that surpassed pre-defined thresholdEnrollment in trials for fifth and sixth indications to begin in 2021Additional efgartigimod indications to be evaluated as part of collaboration with Zai Lab Limited Data expected mid-year from Phase 1 trial of C2 inhibitor, ARGX-117; Phase 2 dosing plan to be identified for indications, including multifocal motor neuropathy (MMN) Phase 2 trial of MMN on track to start by end of 2021 Combination trials of cusatuzumab remain ongoing for treatment of acute myeloid leukemia (AML) as part of global collaboration and licensing agreement with Cilag GmbH International, an affiliate of Janssen Decision to initiate additional cusatuzumab studies under collaboration will be determined following review of all available data Immunology Innovation Program (IIP) continues to grow pipeline through wholly-owned development, partnered opportunities, asset-centric spinoff companies and the addition of strategic technology capabilities Preclinical work ongoing in early-stage pipeline, including ARGX-118, ARGX-119 and ARGX-12015-20 discovery programs under evaluation at any point in time that have emerged from IIPInitiated collaboration and license agreement with Elektrofi to explore new subcutaneous formulations for current and future pipeline candidates, including efgartigimod Secured exclusivity for FcRn and one additional target Ongoing development of ARGX-112 (LEO Pharma), ARGX-114 (AgomAb), ARGX-115 (ABBV-151, AbbVie) and ARGX-116 (Staten Biotech) by IIP collaboration partners Strong balance sheet and expanded Board of Directors support transition into integrated, global immunology organization Completed public offering of 3,593,750 ordinary shares in February 2021 with gross proceeds of $1.15 billionImplemented transition agreement for Chief Financial Officer Eric Castaldi as part of evolution to commercial-stage company; recruitment efforts ongoing for U.S.-based successorProposed resolutions presented during Annual General Meeting of Shareholders were approved, including: Appointment to Board of Directors of Yvonne Greenstreet, President and Chief Operating Officer of AlnylamRe-appointment of Anthony Rosenberg to Board of DirectorsApproval of new remuneration policy argenx to host virtual R&D Day on July 20, 2021 to share long-term corporate vision, disclose additional potential efgartigimod indications and provide updates across immunology pipeline. FIRST QUARTER 2021 FINANCIAL RESULTS (CONSOLIDATED) Three Months Ended March 31, (in thousands of $ except for shares and EPS) 2021 2020 VarianceRevenue $158,155 $21,139 $137,017Other operating income 9,260 4,672 4,588Total operating income 167,415 25,811 141,604 Research and development expenses (122,328) (104,661) (17,666)Selling, general and administrative expenses (56,253) (27,609) (28,644)Total operating expenses (178,580) (132,270) (46,310)Change in fair value on non-current financial assets 11,152 0 11,152Operating loss $(13) $(106,459) $106,446 Financial income/(expenses) (420) (3,591) 3,171Exchange gain/(losses) (28,817) 22,985 (51,802)Loss before taxes $(29,249) $(87,064) $57,815 Income taxes (11,184) (1,200) (9,984)Loss for the period and total comprehensive loss $(40,433) $(88,264) $47,831 Weighted average number of shares outstanding 49,946,515 42,786,194 Basic and diluted profit/(loss) per share (in $) (0.81) (2.06) Net increase/(decrease) in cash, cash equivalents and current financial assets compared to year-end 2020 and 2019 910,903 (70,318) Cash, cash equivalents and current financial assets at the end of the period 2,907,355 1,430,343 DETAILS OF THE FINANCIAL RESULTS As of January 1, 2021, the Company changed its functional and presentation currency from euro to U.S. dollars, which results in reporting its financial highlights in U.S. dollar as compared to euro in prior periods. Historical financials have been converted at the average exchange rate of the related period. Cash, cash equivalents and current financial assets totaled $2,907.4 million on March 31, 2021, compared to $1,996.5 million on December 31, 2020. The increase in cash, cash equivalents and current financial assets resulted primarily from (i) the closing of a global offering, which resulted in the receipt of $1,092.1 million in net proceeds in February 2021, (ii) the net receipt of a $73.1 million non-creditable, non-refundable development cost-sharing payment in the form of newly issued Zai Lab shares received as part of the strategic collaboration for efgartigimod in Greater China, partially offset by (iii) the payment of $98.0 million related to the purchase of a priority review voucher from Bayer HealthCare Pharmaceuticals and other net cash flows used in operating activities. Total operating income increased by $141.6 million for the three months ended March 31, 2021 to $167.4 million, compared to $25.8 million for the three months ended March 31, 2020. The increase was primarily due to the closing of the strategic collaboration for efgartigimod with Zai Lab, resulting in the recognition of $151.9 million in collaboration revenue. Research and development expenses increased by $17.7 million for the three months ended March 31, 2021 to $122.3 million, compared to $104.7 million for the three months ended March 31, 2020. The increase in the first three months of 2021 resulted primarily from higher external research and development expenses, mainly related to the efgartigimod program in multiple indications and other clinical and preclinical programs. Furthermore, the research and development personnel expenses increased due to a planned increase in headcount and the increased costs of the share-based payment compensation plans related to the grant of stock options. Selling, general and administrative expenses totaled $56.3 million for the three months ended March 31, 2021, compared to $27.6 million for the three months ended March 31, 2020. The increase resulted primarily from higher personnel expenses, including the costs of the share-based payment compensation plans related to the grant of stock options, and consulting fees linked to the preparation of a possible future commercialization of efgartigimod. The increase in fair value on non-current financial assets amounted to $11.2 million for the three months ended March 31, 2021, which is the result of the closing of a Series B financing round of AgomAb Therapeutics, for which the Company maintains a profit share in exchange for granting the license for the use of HGF-mimetic antibodies from the SIMPLE Antibody™ platform. Exchange losses totaled $28.8 million for the three months ended March 31, 2021, compared to an exchange gain of $23.0 million for the three months ended March 31, 2020. As a result of the change in the Company’s functional and presentation currency, the exchange losses for the three months ended March 31, 2021 are reflecting the unfavorable change in euro/U.S. dollar exchange rate, mainly attributable to unrealized exchange rate losses on cash, cash equivalents and current financial asset position in euro. FINANCIAL GUIDANCE Based on current plans to fund anticipated operating expenses and capital expenditures, argenx continues to expect its 2021 cash burn to approximately double from 2020. The increased spend will support the Company’s transition to an integrated immunology company, including the build-out of global commercial infrastructure and drug product inventory ahead of the expected launch of efgartigimod in gMG in the U.S, the advancement of its clinical-stage pipeline, including seven expected global trials of efgartigimod, and the continued investment in its Immunology Innovation Program. EXPECTED 2021 FINANCIAL CALENDAR July 29, 2021: HY 2021 financial results and business updateOctober 28, 2021: Q3 2021 financial results and business update CONFERENCE CALL DETAILSThe first quarter 2021 financial results and business update will be discussed during a conference call and webcast presentation today at 2:30 pm CEST/8:30 am ET. A webcast of the live call may be accessed on the Investors section of the argenx website at argenx.com/investors. A replay of the webcast will be available on the argenx website. Dial-in numbers:Please dial in 15 minutes prior to the live call. Belgium 0800 389 13 France 0805 102 319 Netherlands 0800 949 4506 United Kingdom 0800 279 9489 United States 1 844 808 7140International 1 412 902 0128 About argenxargenx is a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases and cancer. Partnering with leading academic researchers through its Immunology Innovation Program (IIP), argenx aims to translate immunology breakthroughs into a world-class portfolio of novel antibody-based medicines. argenx is evaluating efgartigimod in multiple serious autoimmune diseases, and cusatuzumab in hematological cancers in collaboration with Janssen. argenx is also advancing several earlier stage experimental medicines within its therapeutic franchises. argenx has offices in Belgium, the United States, Japan, and Switzerland. For more information, visit www.argenx.com and follow us on LinkedIn at https://www.linkedin.com/company/argenx/ and Twitter at https://twitter.com/argenxglobal. For further information, please contact: Media:Kelsey KirkKKirk@argenx.com Joke Comijn (EU)jcomijn@argenx.com Investors:Beth DelGiaccobdelgiacco@argenx.com Michelle Greenblattmgreenblatt@argenx.com Forward-looking Statements The contents of this announcement include statements that are, or may be deemed to be, “forward-looking statements.” These forward-looking statements can be identified by the use of forward-looking terminology, including the terms “believes,” “estimates,” “anticipates,” “expects,” “intends,” “may,” “will,” or “should” and include statements argenx makes concerning its statement that the submissions in China and the EU are on track and that it is well-positioned for a global launch of its first-in-class FcRn antagonist, including that BLA for IV efgartigimod for treatment of gMG accepted for review by the U.S. Food and Drug Administration (FDA) in March 2021 with target action date of December 17, 2021 under Prescription Drug User Fee Act (PDUFA), J-MAA submitted to Japan’s PMDA and accepted for review with anticipated Japan commercial launch in 2022, MAA expected to be filed with European Medicines Agency (EMA) in second half of 2021 and Zai Lab Limited to discuss potential accelerated regulatory pathway for approval in China with National Medical Products Administration (NMPA); statements regarding its commercial readiness; its statement that enrollment in trials for fifth and sixth indications to begin in 2021; its statement that data expected mid-year from Phase 1 trial of C2 inhibitor, ARGX-117; Phase 2 dosing plan to be identified for indications including multifocal motor neuropathy (MMN), and Phase 2 trial of MMN on track to start by end of 2021; its expectation that its 2021 cash burn will approximately double from 2020; its hope to reach patients this year; its statements regarding the therapeutic potential of Efgartigimod in patients with gMG as well as several other severe autoimmune diseases mediated by IgG autoantibodies; its plans to start enrollment in two additional efgartigimod indications this year, its expectation to have Phase 1 data mid-year for its C2 inhibitor, ARGX-117, 2021 business and financial outlook and related plans; the therapeutic potential of its product candidates; the intended results of its strategy and argenx’s, and its collaboration partners’, advancement of, and anticipated clinical development, data readouts and regulatory milestones and plans, including the timing of planned clinical trials and expected data readouts; the design of future clinical trials and the timing and outcome of regulatory filings and regulatory approvals. By their nature, forward-looking statements involve risks and uncertainties and readers are cautioned that any such forward-looking statements are not guarantees of future performance. argenx’s actual results may differ materially from those predicted by the forward-looking statements as a result of various important factors, including the effects of the COVID-19 pandemic, argenx’s expectations regarding its the inherent uncertainties associated with competitive developments, preclinical and clinical trial and product development activities and regulatory approval requirements; argenx’s reliance on collaborations with third parties; estimating the commercial potential of argenx’s product candidates; argenx’s ability to obtain and maintain protection of intellectual property for its technologies and drugs; argenx’s limited operating history; and argenx’s ability to obtain additional funding for operations and to complete the development and commercialization of its product candidates. A further list and description of these risks, uncertainties and other risks can be found in argenx’s U.S. Securities and Exchange Commission (SEC) filings and reports, including in argenx’s most recent annual report on Form 20-F filed with the SEC as well as subsequent filings and reports filed by argenx with the SEC. Given these uncertainties, the reader is advised not to place any undue reliance on such forward-looking statements. These forward-looking statements speak only as of the date of publication of this document. argenx undertakes no obligation to publicly update or revise the information in this press release, including any forward-looking statements, except as may be required by law.

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  • argenx announces results of Annual General Meeting of Shareholders

    May 11, 2021Breda, the Netherlands – argenx SE (Euronext & Nasdaq: ARGX), a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases and cancer, today announced that the proposed resolutions presented at its Annual General Meeting of Shareholders, held today at 10:00 a.m. CEST, were duly passed. As part of the approved resolutions: Yvonne Greenstreet has been appointed as non-executive director to the Board of Directors for a term of four (4) years;Anthony Rosenberg has been re-appointed as non-executive director to the Board of Directors for an additional term of four (4) years;the Board of Directors has been authorized to issue additional shares up to a maximum of 10% of the share capital of argenx for a period of 18 months from the Annual General Meeting;the 2020 remuneration report as well as the Company’s new remuneration policy has been approved;Deloitte Accountants B.V. has been appointed as the Company’s auditor for the 2021 financial year. In line with previous announcements, Dr. David Lacey has today resigned from the board of directors and will transition to an advisory role for the company. The results of the votes and all documents relating to the shareholders’ meeting will be available on the Company’s website at www.argenx.com. About argenx argenx is a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases and cancer. Partnering with leading academic researchers through its Immunology Innovation Program (IIP), argenx aims to translate immunology breakthroughs into a world-class portfolio of novel antibody-based medicines. argenx is evaluating efgartigimod in multiple serious autoimmune diseases, and cusatuzumab in hematological cancers in collaboration with Janssen. argenx is also advancing several earlier stage experimental medicines within its therapeutic franchises. argenx has offices in Belgium, the United States, Japan and Switzerland. For more information, visit www.argenx.com and follow us on LinkedIn at https://www.linkedin.com/company/argenx/ and Twitter at https://twitter.com/argenxglobal. For further information, please contact: Investors: Beth DelGiaccobdelgiacco@argenx.com Michelle Greenblattmgreenblatt@argenx.com Forward-looking Statements The contents of this announcement include statements that are, or may be deemed to be, “forward-looking statements.” These forward-looking statements can be identified by the use of forward-looking terminology, including the terms “believes,” “estimates,” “anticipates,” “expects,” “intends,” “may,” “will,” or “should” and include statements argenx makes concerning its 2021 business and financial outlook and related plans; the therapeutic potential of its product candidates; the intended results of its strategy and argenx’s, and its collaboration partners’, advancement of, and anticipated clinical development, data readouts and regulatory milestones and plans, including the timing of planned clinical trials and expected data readouts; the design of future clinical trials and the timing and outcome of regulatory filings and regulatory approvals. By their nature, forward-looking statements involve risks and uncertainties and readers are cautioned that any such forward-looking statements are not guarantees of future performance. argenx’s actual results may differ materially from those predicted by the forward-looking statements as a result of various important factors, including the effects of the COVID-19 pandemic, argenx’s expectations regarding its the inherent uncertainties associated with competitive developments, preclinical and clinical trial and product development activities and regulatory approval requirements; argenx’s reliance on collaborations with third parties; estimating the commercial potential of argenx’s product candidates; argenx’s ability to obtain and maintain protection of intellectual property for its technologies and drugs; argenx’s limited operating history; and argenx’s ability to obtain additional funding for operations and to complete the development and commercialization of its product candidates. A further list and description of these risks, uncertainties and other risks can be found in argenx’s U.S. Securities and Exchange Commission (SEC) filings and reports, including in argenx’s most recent annual report on Form 20-F filed with the SEC as well as subsequent filings and reports filed by argenx with the SEC. Given these uncertainties, the reader is advised not to place any undue reliance on such forward-looking statements. These forward-looking statements speak only as of the date of publication of this document. argenx undertakes no obligation to publicly update or revise the information in this press release, including any forward-looking statements, except as may be required by law. Attachment PR 210511 argenx Results Annual General Shareholders meeting_FINAL

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  • Halozyme Therapeutics Inc (HALO) Q1 2021 Earnings Call Transcript

    Leading the call will be Dr. Helen Torley, Halozyme's President and Chief Executive Officer, who will provide an update on our business; and Elaine Sun, our Chief Financial Officer, who will review our financial results for the first quarter. Thank you, Al. I'm pleased to report that our first quarter results provided a strong start to 2021 for Halozyme.

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  • argenx to Report First Quarter 2021 Financial Results and Business Update on May 14, 2021

    May 7, 2021Breda, the Netherlands – argenx (Euronext & Nasdaq: ARGX), a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases and cancer, today announced that it will host a conference call and audio webcast on Friday, May 14, 2021 at 2:30 p.m. CET (8:30 a.m. ET) to discuss its first quarter 2021 financial results and provide a business update. A webcast of the live call may be accessed on the Investors section of the argenx website at argenx.com/investors. A replay of the webcast will be available on the argenx website for approximately one year following the call. Dial-in numbers:Please dial in 15 minutes prior to the live call. Belgium 0800 389 13France 0805 102 319Netherlands 0800 949 4506United Kingdom 0800 279 9489United States 1 844 808 7140International 1 412 902 0128 About argenx argenx is a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases and cancer. Partnering with leading academic researchers through its Immunology Innovation Program (IIP), argenx aims to translate immunology breakthroughs into a world-class portfolio of novel antibody-based medicines. argenx is evaluating efgartigimod in multiple serious autoimmune diseases, and cusatuzumab in hematological cancers in collaboration with Janssen. argenx is also advancing several earlier stage experimental medicines within its therapeutic franchises. argenx has offices in Belgium, the United States, Japan and Switzerland. For more information, visit https://www.argenx.com/ and follow us on LinkedIn at https://www.linkedin.com/company/argenx/ and Twitter at https://twitter.com/argenxglobal. For further information, please contact: Media:Kelsey Kirkkkirk@argenx.com Joke Comijn jcomijn@argenx.com Investors: Beth DelGiaccobdelgiacco@argenx.com Michelle Greenblattmgreenblatt@argenx.com

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  • argenx Management to Present at Upcoming Virtual Investor Conferences

    April 28, 2021Breda, the Netherlands – argenx (Euronext & Nasdaq: ARGX), a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases and cancer, today announced that members of management will participate in the following upcoming conferences: Kempen Life Sciences Conference – 2021 Thematic Virtual Series. Management will participate in investor meetings on Wednesday, May 5, 2021.BofA Securities Virtual 2021 Healthcare Conference. Fireside chat on Thursday, May 13, 2021 at 8:00 a.m. ET. Additional information regarding these events will be available on the Company’s website at www.argenx.com. About argenxargenx is a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases and cancer. Partnering with leading academic researchers through its Immunology Innovation Program (IIP), argenx aims to translate immunology breakthroughs into a world-class portfolio of novel antibody-based medicines. argenx is evaluating efgartigimod in multiple serious autoimmune diseases, and cusatuzumab in hematological cancers in collaboration with Janssen. argenx is also advancing several earlier stage experimental medicines within its therapeutic franchises. argenx has offices in Belgium, the United States, and Japan. For more information, visit https://www.argenx.com/ and follow us on LinkedIn at https://www.linkedin.com/company/argenx/ and Twitter at https://twitter.com/argenxglobal. For further information, please contact: Media: Kelsey Kirkkkirk@argenx.com Joke Comijn jcomijn@argenx.com Investors: Beth DelGiaccobdelgiacco@argenx.com Michelle Greenblattmgreenblatt@argenx.com

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  • argenx announces Annual General Meeting of Shareholders on May 11, 2021

    March 30, 2021 Breda, the Netherlands – argenx SE (Euronext & Nasdaq: ARGX), a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases and cancer, today announced that an annual general meeting of shareholders will be held at 10:00 a.m. CEST on Tuesday May 11, 2021 at the Hilton Amsterdam Airport Schiphol, Schiphol Boulevard 701, 1118 BG Schiphol, the Netherlands. The shareholders and all other persons with meeting rights are invited to attend the annual general meeting of shareholders. The formal notice of convocation (including information on attending the meeting in person or by proxy, requirements for notification and registration for the meeting and regarding the e-voting system) is available on the argenx website www.argenx.com and on www.abnamro.com/evoting. Agenda The full agenda for the meeting as well as all ancillary documents relevant for the meeting are available via the argenx website and are also available for inspection at the argenx offices. A free copy thereof may also be obtained by e-mailing annualmeeting@argenx.com. In addition to recurrent items on the agenda, such as the discussion and adoption of the 2020 Annual Accounts, an advisory vote on the company’s remuneration report, the discharge of the directors for their duties performed in 2020 and the authorization of the Board of Directors to issue shares and to limit or exclude pre-emptive rights in relation thereto, the following items, amongst others, are proposed: Approval of the updated and amended remuneration policy;Appointment of Yvonne Greenstreet and re-appointment of Anthony Rosenberg as non-executive directors to the Board of Directors; andAppointment of Deloitte Accountants B.V. for the 2021 financial year. Due to the ongoing COVID-19 pandemic, argenx would like to encourage shareholders to use the voting by (electronic) proxy option as referred to in the convocation. The Company will provide a live audio-webcast of the general meeting to enable as many shareholders as possible to attend. About argenx argenx is a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases and cancer. Partnering with leading academic researchers through its Immunology Innovation Program (IIP), argenx aims to translate immunology breakthroughs into a world-class portfolio of novel antibody-based medicines. argenx is evaluating efgartigimod in multiple serious autoimmune diseases, and cusatuzumab in hematological cancers in collaboration with Janssen. argenx is also advancing several earlier stage experimental medicines within its therapeutic franchises. argenx has offices in Belgium, the United States, Japan and Switzerland. For more information, visit www.argenx.com and follow us on LinkedIn at https://www.linkedin.com/company/argenx/ and Twitter at https://twitter.com/argenxglobal. For further information, please contact: Investors: Beth DelGiacco (US)bdelgiacco@argenx.com Joke Comijn (EU) jcomijn@argenx.com Forward-looking Statements The contents of this announcement include statements that are, or may be deemed to be, “forward-looking statements.” These forward-looking statements can be identified by the use of forward-looking terminology, including the terms “believes,” “estimates,” “anticipates,” “expects,” “intends,” “may,” “will,” or “should” and include statements argenx makes concerning its 2021 business and financial outlook and related plans; the therapeutic potential of its product candidates; the intended results of its strategy and argenx’s, and its collaboration partners’, advancement of, and anticipated clinical development, data readouts and regulatory milestones and plans, including the timing of planned clinical trials and expected data readouts; the design of future clinical trials and the timing and outcome of regulatory filings and regulatory approvals. By their nature, forward-looking statements involve risks and uncertainties and readers are cautioned that any such forward-looking statements are not guarantees of future performance. argenx’s actual results may differ materially from those predicted by the forward-looking statements as a result of various important factors, including the effects of the COVID-19 pandemic, argenx’s expectations regarding its the inherent uncertainties associated with competitive developments, preclinical and clinical trial and product development activities and regulatory approval requirements; argenx’s reliance on collaborations with third parties; estimating the commercial potential of argenx’s product candidates; argenx’s ability to obtain and maintain protection of intellectual property for its technologies and drugs; argenx’s limited operating history; and argenx’s ability to obtain additional funding for operations and to complete the development and commercialization of its product candidates. A further list and description of these risks, uncertainties and other risks can be found in argenx’s U.S. Securities and Exchange Commission (SEC) filings and reports, including in argenx’s most recent annual report on Form 20-F filed with the SEC as well as subsequent filings and reports filed by argenx with the SEC. Given these uncertainties, the reader is advised not to place any undue reliance on such forward-looking statements. These forward-looking statements speak only as of the date of publication of this document. argenx undertakes no obligation to publicly update or revise the information in this press release, including any forward-looking statements, except as may be required by law. Attachment PR210331 argenx announces 2021 AGM FINAL

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  • argenx: Q4 Earnings Insights

    Shares of argenx (NASDAQ:ARGX) fell 3.2% in pre-market trading after the company reported Q4 results. Quarterly Results Earnings per share were down 60.08% year over year to ($4.21), which missed the estimate of ($3.19). Revenue of $7,587,000 declined by 60.98% year over year, which missed the estimate of $19,310,000. Looking Ahead argenx hasn't issued any earnings guidance for the time being. argenx hasn't issued any revenue guidance for the time being. Details Of The Call Date: Mar 04, 2021 View more earnings on ARGX Time: 08:30 AM ET Webcast URL: https://www.argenx.com/investors/events-presentations# Price Action 52-week high: $382.15 Company's 52-week low was at $103.75 Price action over last quarter: Up 22.20% Company Profile argenx SE is a clinical stage biotechnology company. It is engaged in the business of developing a pipeline of differentiated antibody-based therapies for the treatment of severe autoimmune diseases and cancer. Its product pipeline includes product candidates such as ARGX-111, ARGX-109, ARGX-115, ARGX-112, and others. The company operates in the Netherlands, Germany, Denmark, Belgium, Switzerland, the United States, and Luxembourg. It derives the majority of its revenues from Switzerland. See more from BenzingaClick here for options trades from BenzingaEarnings Scheduled For March 4, 2021© 2021 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.

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  • argenx Reports Full Year 2020 Financial Results and Provides Fourth Quarter Business Update

    - Biologics License Application (BLA) for IV efgartigimod accepted for review by U.S. Food and Drug Administration (FDA) for generalized myasthenia gravis (gMG) - Pre-approval access program opened in U.S. and Europe for eligible gMG patients - Management to host conference call today at 2:30 pm CEST (8:30 am ET) - March 4, 2021 Breda, the Netherlands – argenx (Euronext & Nasdaq: ARGX), a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases and cancer, today reported financial results for the full year 2020 and provided a fourth quarter business update. “2020 was an exceptional year for argenx, marked by execution across the organization and highlighted by the positive results of our pivotal Phase 3 ADAPT trial. We have started 2021 on strong footing with the FDA’s acceptance for review of the BLA for efgartigimod, bringing us one step closer to offering a new therapy option to people living with gMG. In preparation for our first commercial launch, we remain committed to a series of educational and engagement efforts with patients, physicians and payors on FcRn as a target and the unmet disease burden that gMG patients face,” said Tim Van Hauwermeiren, Chief Executive Officer of argenx. “With proof-of-concept established for efgartigimod in four indications and enrollment on track to begin in the fifth and sixth indications this year, we are building out a broad development plan with our FcRn antagonist. In addition, we expect Phase 1 healthy volunteer data mid-year from our C2 antagonist ARGX-117, our second program in severe autoimmunity, solidifying our commitment to continued pipeline expansion with antibody-based medicines that have potential in multiple autoimmune indications,” concluded Mr. Van Hauwermeiren. FOURTH QUARTER 2020 AND RECENT BUSINESS UPDATE BLA for efgartigimod accepted for review by FDA; on track with commercial and regulatory preparations in the U.S., Japan, the EU and China. BLA for IV efgartigimod for treatment of gMG accepted for review by FDA with action date set for December 17, 2021 under Prescription Drug User Fee Act (PDUFA)Japanese Marketing Authorization Application (J-MAA) expected to be filed with Pharmaceuticals and Medical Devices Agency (PMDA) in first half of 2021 with anticipated Japan commercial launch in 2022MAA expected to be filed with European Medicines Agency (EMA) in second half of 2021Zai Lab Limited to discuss potential accelerated regulatory pathway for approval in China with National Medical Products Administration (NMPA)Commercial readiness activities on track, including: Build-out of supply chain to ensure ample commercial product available at launch to meet early demandHiring of experienced, neurology-focused sales team with aim to have approximately 70 sales representatives in place for launchOngoing education efforts with key stakeholder groups, including patients, physicians and payors Launched pre-approval access program (PAA) in the U.S. and Europe to open availability of efgartigimod to people living with gMG who have a high degree of unmet clinical need and are not able to participate in a clinical trial Seven global trials to be ongoing in 2021 of efgartigimod across IV and subcutaneous (SC) formulations; proof-of-concept now demonstrated in four indications, which strategically fit within growing commercial franchises. ADAPT-SC: Enrollment ongoing in registrational trial evaluating non-inferiority based on pharmacodynamic effect of SC efgartigimod compared to IV efgartigimod for treatment of gMG; trial expected to enroll approximately 50 patientsADHERE: Enrollment ongoing in registrational trial evaluating SC efgartigimod for treatment of chronic inflammatory demyelinating polyneuropathy (CIDP) following interim analysis of safety data as well as efficacy assessments that surpassed pre-defined “GO” threshold; trial expected to enroll approximately 130 patientsADVANCE and ADVANCE-SC: Registrational trials ongoing of IV and SC efgartigimod for treatment of primary immune thrombocytopenia (ITP); trials expected to each enroll approximately 156 patientsADDRESS: Registrational trial ongoing of SC efgartigimod for treatment of pemphigus (vulgaris and foliaceus); trial expected to enroll approximately 150 patientsEnrollment in fifth and sixth indications to begin in 2021Agreement with Zai Lab Limited expected to expand and accelerate global development of efgartigimod, including into additional autoimmune indications Data expected mid-2021 from Phase 1 healthy volunteer trial of ARGX-117, a potential first-in-class C2 antagonist and second program with broad applicability in severe autoimmunity. -Trial to evaluate safety and tolerability of single and multiple ascending doses of IV and SC ARGX-117, and to identify dose to take forward into potential Phase 2 proof-of-concept trials, including for multifocal motor neuropathy (MMN) Combination trials of cusatuzumab remain ongoing for treatment of acute myeloid leukemia (AML) as part of global collaboration and licensing agreement with Cilag GmbH International, an affiliate of Janssen. Data update from Phase 2 CULMINATE trial evaluating cusatuzumab in combination with azacitidine for treatment of newly diagnosed AML to be presented in peer-reviewed forumDecision to initiate additional cusatuzumab studies under collaboration will be determined following review of all available data including ongoing Phase 1b ELEVATE trial (NCT04150887), which is evaluating cusatuzumab in combination with venetoclax and azacitidine for treatment of newly diagnosed AML Immunology Innovation Program (IIP) continues to drive pipeline expansion by identifying potential value-creation opportunities through collaboration with leading disease biologists. Preclinical work ongoing in early-stage pipeline, including ARGX-118, ARGX-119 and ARGX-12017 discovery programs under evaluation that emerged from IIP argenx continues its transition to a global, integrated, immunology organization. Geneva office opened to support commercial infrastructure ahead of expected EU launch of efgartigimodPlanned transition agreement in place for Chief Financial Officer Eric Castaldi as part of evolution to commercial-stage company; recruitment efforts ongoing for U.S.-based successorYvonne Greenstreet, President and Chief Operating Officer of Alnylam, has been nominated to Board of Directors to fill position of Dr. David Lacey, who intends to transition to an advisory role for the CompanyCompleted public offering of 3,593,750 ordinary shares in February 2021 with gross proceeds of $1.15 billion Q4 AND FY2020 FINANCIAL RESULTS Year Ended December 31,(in thousands of € except for shares and EPS) 2020 2019 VarianceRevenue €36,425 €69,783 €(33,358)Other operating income 18,109 12,801 5,308Total operating income 54,534 82,584 (28,050) Research and development expenses (325,479) (197,665) (127,814)Selling, general and administrative expenses (149,367) (64,569) (84,798)Total operating expenses (474,846) (262,234) (212,612) Change in fair value on non-current financial assets 2,544 1,096 1,448 Operating loss €(417,769) €(178,554) €(239,215) Financial income/(expense) (1,414) 14,275 (15,689)Exchange gains/(losses) (106,956) 6,066 (113,022) Loss before taxes €(526,139) €(158,213) €(367,926) Income tax expense €(2,784) €(4,752) €1,968 Loss for the year and total comprehensive loss €(528,923) €(162,965) €(365,958) Loss for the year and total comprehensive loss attributable to: Owners of the parent €(528,923) €(162,965) €(365,958)Weighted average number of shares outstanding 45,410,442 38,619,121 Basic and diluted loss per share (in €) (11.65) (4.22) Net increase in cash and cash equivalents and current financial assets compared to year-end 2019 and 2018 291,147 771,252 Cash and cash equivalents and current financial assets at the end of the period 1,626,968 1,335,821 DETAILS OF FINANCIAL RESULTS Cash and cash equivalents and current financial assets totaled €1,627.0 million on December 31, 2020, compared to €1,335.8 million on December 31, 2019. The increase in cash and cash equivalents and current financial assets resulted primarily from the closing of a global offering in May 2020, including a U.S. offering and a European private placement, which resulted in the receipt of €778.1 million in gross proceeds, decreased by €47.4 million of underwriter discounts and commissions, and offering expenses, partially offset by net cash flows used in operating activities. Revenue decreased by €33.4 million for the year ended December 31, 2020 to €36.4 million, compared to €69.8 million for the year ended December 31, 2019. The decrease was due to the milestone payments following the first-in-human clinical trial with ABBV-151 under the AbbVie collaboration which was achieved in the year ended December 31, 2019, partly offset by revenue recognition of the transaction price related to the Janssen collaboration. The increase in other income is primarily driven by increased research and development incentives and higher payroll tax rebates for employing certain highly qualified research and development personnel. Research and development expenses increased by €127.8 million for the year ended December 31, 2020 to €325.5 million, compared to €197.7 million for the year ended December 31, 2019. The increase resulted primarily from higher external research and development expenses, primarily related to the efgartigimod program in various indications, cusatuzumab program and other clinical and preclinical programs. Furthermore, the personnel expenses increased due to a planned increase in headcount. Selling, general and administrative expenses totaled €149.4 million for the year ended December 31, 2020, compared to €64.6 million for the year ended December 31, 2019. The increase primarily resulted from higher personnel expenses and consulting fees related to the preparation of a possible future commercialization of argenx’s lead product candidate efgartigimod. For the year ended December 31, 2020, financial expenses, which is the net of primarily interest received and changes in fair value of invested funds, amounted to €1.4 million, compared to a financial income of €14.3 million for the year ended December 31, 2020. Financial expenses correspond mainly to the decrease in net asset value of money invested funds following the impact of the COVID-19 outbreak on the financial markets. Exchange losses totaled €107.0 million for the year ended December 31, 2020, compared to an exchange gain of €6.1 million for the year ended December 31, 2019. The unfavorable change is mainly attributable to unrealized exchange rate losses on cash and cash equivalents and current financial asset position in U.S. dollars. FINANCIAL GUIDANCE Based on current plans to fund anticipated operating expenses and capital expenditures, argenx expects its cash burn to increase significantly in 2021, approximately doubling compared to 2020. The increased spend will support the Company’s transition to an integrated immunology company, including the build-out of global commercial infrastructure and drug product inventory ahead of the expected launch of efgartigimod in gMG in the U.S, the advancement of its clinical-stage pipeline, including seven expected global trials of efgartigimod, and the continued investment in its Immunology Innovation Program. EXPECTED 2021 FINANCIAL CALENDAR May 14, 2021: Q1 2021 financial results and business updateJuly 29, 2021: HY 2021 financial results and business updateOctober 28, 2021: Q3 2021 financial results and business update CONFERENCE CALL DETAILSThe full year 2020 results and fourth quarter business update will be discussed during a conference call and webcast presentation today at 2:30 pm CEST/8:30 am ET. A webcast of the live call may be accessed on the Investors section of the argenx website at argenx.com/investors. A replay of the webcast will be available on the argenx website. Dial-in numbers:Please dial in 15 minutes prior to the live call. Belgium 0800 389 13 France 0805 102 319 Netherlands 0800 949 4506 United Kingdom 0800 279 9489 United States 1 844 808 7140International 1 412 902 0128 About argenxargenx is a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases and cancer. Partnering with leading academic researchers through its Immunology Innovation Program (IIP), argenx aims to translate immunology breakthroughs into a world-class portfolio of novel antibody-based medicines. argenx is evaluating efgartigimod in multiple serious autoimmune diseases, and cusatuzumab in hematological cancers in collaboration with Janssen. argenx is also advancing several earlier stage experimental medicines within its therapeutic franchises. argenx has offices in Belgium, the United States, and Japan. For more information, visit www.argenx.com and follow us on LinkedIn at https://www.linkedin.com/company/argenx/ and Twitter at https://twitter.com/argenxglobal. For further information, please contact: Media:Kelsey KirkKKirk@argenx.com Investors:Beth DelGiaccobdelgiacco@argenx.com Joke Comijn (EU)jcomijn@argenx.com Forward-looking Statements The contents of this announcement include statements that are, or may be deemed to be, “forward-looking statements.” These forward-looking statements can be identified by the use of forward-looking terminology, including the terms “believes,” “estimates,” “anticipates,” “expects,” “intends,” “may,” “will,” or “should” and include statements argenx makes concerning its 2021 business and financial outlook and related plans; the therapeutic potential of its product candidates; the intended results of its strategy and argenx’s, and its collaboration partners’, advancement of, and anticipated clinical development, data readouts and regulatory milestones and plans, including the timing of planned clinical trials and expected data readouts; the design of future clinical trials and the timing and outcome of regulatory filings and regulatory approvals. By their nature, forward-looking statements involve risks and uncertainties and readers are cautioned that any such forward-looking statements are not guarantees of future performance. argenx’s actual results may differ materially from those predicted by the forward-looking statements as a result of various important factors, including the effects of the COVID-19 pandemic, argenx’s expectations regarding its the inherent uncertainties associated with competitive developments, preclinical and clinical trial and product development activities and regulatory approval requirements; argenx’s reliance on collaborations with third parties; estimating the commercial potential of argenx’s product candidates; argenx’s ability to obtain and maintain protection of intellectual property for its technologies and drugs; argenx’s limited operating history; and argenx’s ability to obtain additional funding for operations and to complete the development and commercialization of its product candidates. A further list and description of these risks, uncertainties and other risks can be found in argenx’s U.S. Securities and Exchange Commission (SEC) filings and reports, including in argenx’s most recent annual report on Form 20-F filed with the SEC as well as subsequent filings and reports filed by argenx with the SEC. Given these uncertainties, the reader is advised not to place any undue reliance on such forward-looking statements. These forward-looking statements speak only as of the date of publication of this document. argenx undertakes no obligation to publicly update or revise the information in this press release, including any forward-looking statements, except as may be required by law. Attachment Q4FY20 Press Release - Financial Tables_FINAL

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  • argenx Announces FDA Acceptance of BLA Filing for Efgartigimod for the Treatment of Generalized Myasthenia Gravis

    Regulated Information/Inside Information argenx Announces FDA Acceptance of BLA Filing for Efgartigimod for the Treatment of Generalized Myasthenia Gravis If approved, efgartigimod will be the first-and-only approval of an FcRn antagonistPrescription Drug User Fee Act (PDUFA) target action date is December 17, 2021Pre-approval access program opened in U.S. for efgartigimod for eligible people living with gMG Breda, the Netherlands – March 2, 2021 – argenx (Euronext & Nasdaq: ARGX), a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases and cancers, today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the Biologics License Application (BLA) for intravenous (IV) efgartigimod, the company’s investigational FcRn antagonist and lead product candidate, for the treatment of generalized myasthenia gravis (gMG). The FDA has set a standard 10-month review process with a PDUFA target action date of December 17, 2021. “This is an important milestone for argenx in our transition to a commercial-stage company and brings us closer to our mission to reach patients living with gMG, a debilitating neuromuscular disease,” said Tim Van Hauwermeiren, Chief Executive Officer of argenx. “We look forward to closely collaborating with the FDA through the BLA review process and to potentially making our first medicine available.” The BLA included results from the pivotal Phase 3 ADAPT trial evaluating the safety and efficacy of efgartigimod for the treatment of patients with gMG. ADAPT met its primary endpoint defined as percentage of responders on the Myasthenia Gravis Activities of Daily Living (MG-ADL) score among acetylcholine receptor-antibody positive (AChR-Ab+) gMG patients. 67.7% of AChR-Ab+ patients treated with efgartigimod achieved the primary endpoint compared with 29.7% on placebo (p<0.0001). Further, 40% of patients treated with efgartigimod achieved minimal symptom expression defined as MG-ADL scores of 0 (symptom free) or 1, compared to 11.1% of those who received placebo. The safety profile of efgartigimod was comparable to placebo. After completing ADAPT, 90% of participants entered ADAPT+, a three-year open-label extension study evaluating the long-term safety and tolerability of efgartigimod. There are currently 118 patients still enrolled in ADAPT+. argenx also announced today the opening of its pre-approval access (PAA) program in the U.S., which will allow eligible people living with gMG to receive treatment with efgartigimod. The purpose of the PAA is to open availability of an investigational treatment to people who have a high degree of unmet clinical need with gMG and are not able to participate in a clinical trial. argenx is also on track to submit an application for efgartigimod to Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) in the first half of 2021 and the European Medicines Agency (EMA) in the second half of 2021. About Efgartigimod Efgartigimod is an investigational antibody fragment designed to reduce disease-causing immunoglobulin G (IgG) antibodies and block the IgG recycling process. Efgartigimod binds to the neonatal Fc receptor (FcRn), which is widely expressed throughout the body and plays a central role in rescuing IgG antibodies from degradation. Blocking FcRn reduces IgG antibody levels representing a logical potential therapeutic approach for several autoimmune diseases known to be driven by disease-causing IgG antibodies, including: myasthenia gravis (MG), a chronic disease that causes muscle weakness; pemphigus vulgaris (PV), a chronic disease characterized by severe blistering of the skin; immune thrombocytopenia (ITP), a chronic bruising and bleeding disease; and chronic inflammatory demyelinating polyneuropathy (CIDP), a neurological disease leading to impaired motor function. About Myasthenia Gravis Myasthenia gravis (MG) is a rare and chronic autoimmune disease, often causing debilitating and potentially life-threatening muscle weakness. More than 85% of people with MG progress to generalized MG (gMG) within 18 months, where muscles throughout the body may be affected, resulting in extreme fatigue and difficulties with facial expression, speech, swallowing and mobility. In more life-threatening cases, MG can affect the muscles responsible for breathing. There are approximately 65,000 people in the United States and 20,000 people in Japan living with the disease About argenx argenx is a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases and cancer. Partnering with leading academic researchers through its Immunology Innovation Program (IIP), argenx aims to translate immunology breakthroughs into a world-class portfolio of novel antibody-based medicines. argenx is evaluating efgartigimod in multiple serious autoimmune diseases, and cusatuzumab in hematological cancers in collaboration with Janssen. argenx is also advancing several earlier stage experimental medicines within its therapeutic franchises. argenx has offices in Belgium, the United States, and Japan. For more information, visit www.argenx.com and follow us on LinkedIn at https://www.linkedin.com/company/argenx/ and Twitter at https://twitter.com/argenxglobal. Media:Kelsey Kirkkkirk@argenx.com Investors:Beth DelGiaccobdelgiacco@argenx.com Joke Comijn (EU)jcomijn@argenx.com The contents of this announcement include statements that are, or may be deemed to be, forward-looking statements. These forward-looking statements can be identified by the use of forward-looking terminology, including the terms believes, estimates, anticipates, expects, intends, may, will, or should, and include statements argenx makes concerning; its clinical development and regulatory plans, including the timing and outcome of regulatory filings and approvals, including those with FDA, PMDA and EMA described in this announcement and the timing and progress of commercialization activities. By their nature, forward-looking statements involve risks and uncertainties and readers are cautioned that any such forward-looking statements are not guarantees of future performance. argenx’s actual results may differ materially from those predicted by the forward-looking statements as a result of various important factors, including the effects of the COVID-19 pandemic, the inherent uncertainties associated with preclinical and clinical trial and product development activities and regulatory approval requirements; argenx’s reliance on collaborations with third parties; estimating the commercial potential of argenx’s product candidates; argenx’s ability to obtain and maintain protection of intellectual property for its technologies and drugs; argenx’s limited operating history; and argenx’s ability to obtain additional funding for operations and to complete the development and commercialization of its product candidates. A further list and description of these risks, uncertainties and other risks can be found in argenx’s U.S. Securities and Exchange Commission (SEC) filings and reports, including in argenx’s most recent annual report on Form 20-F filed with the SEC as well as subsequent filings and reports filed by argenx with the SEC. Given these uncertainties, the reader is advised not to place any undue reliance on such forward-looking statements. These forward-looking statements speak only as of the date of publication of this document. argenx undertakes no obligation to publicly update or revise the information in this press release, including any forward-looking statements, except as may be required by law. # # #

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