ARGX argenx SE

236
+7.28  (+3%)
Previous Close 228.72
Open 237.23
52 Week Low 103.75
52 Week High 242.37
Market Cap $11,091,945,248
Shares 46,999,768
Float 46,999,768
Enterprise Value $9,439,608,546
Volume 331,833
Av. Daily Volume 198,753
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Upcoming Catalysts

Drug Stage Catalyst Date
Efgartigimod (ARGX-113)
Myasthenia gravis (MG)
BLA Filing
BLA Filing
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Drug Pipeline

Drug Stage Notes
Efgartigimod (ARGX-113) and Enhanze (ADHERE)
Chronic inflammatory demyelinating polyneuropathy
Phase 2
Phase 2
Phase 2 trial has been initiated - noted January 9, 2020.
ARGX-117
Autoimmune diseases
Phase 1
Phase 1
Phase 1 trial to commence by the end of 2020.
Cusatuzumab (ARGX-110)
Acute myeloid leukemia (AML)
Phase 2
Phase 2
Phase 2 enrolment has paused due to COVID-19.
Efgartigimod (ARGX-113)
Pemphigus vulgaris (PV)
Phase 3
Phase 3
Phase 3 trial to commence 2H 2020.
Efgartigimod (ARGX-113)
Immune thrombocytopenia (ITP)
Phase 3
Phase 3
Phase 3 trial initiated December 2019.

Latest News

  1. Regulated information


    June 1, 2020

    Breda, the Netherlands / Ghent, Belgium — argenx ((Euronext &amp, NASDAQ:ARGX), a clinical-stage biotechnology company developing a deep pipeline of differentiated antibody-based therapies for the treatment of severe autoimmune diseases and cancer, announced today the closing of its previously announced global offering of an aggregate of 4,207,292 ordinary shares (including ordinary shares represented by American Depositary Shares (ADSs)), which includes the full exercise of the underwriters' option to purchase 548,777 additional ADSs. The gross proceeds from the global offering were approximately $862.5 million (approximately €784.7 million).

    J.P. Morgan, Cowen and BofA Securities acted as joint bookrunning…

    Regulated information


    June 1, 2020

    Breda, the Netherlands / Ghent, Belgium — argenx ((Euronext &amp, NASDAQ:ARGX), a clinical-stage biotechnology company developing a deep pipeline of differentiated antibody-based therapies for the treatment of severe autoimmune diseases and cancer, announced today the closing of its previously announced global offering of an aggregate of 4,207,292 ordinary shares (including ordinary shares represented by American Depositary Shares (ADSs)), which includes the full exercise of the underwriters' option to purchase 548,777 additional ADSs. The gross proceeds from the global offering were approximately $862.5 million (approximately €784.7 million).

    J.P. Morgan, Cowen and BofA Securities acted as joint bookrunning managers for the offering. Stifel, JMP Securities, Wedbush PacGrow, Nomura and Kempen & Co acted as co-managers for the offering.

    The securities were offered in the United States pursuant to an automatically effective shelf registration statement that was previously filed with the Securities and Exchange Commission (SEC). A preliminary prospectus supplement relating to the securities was filed with the SEC on May 26, 2020 and a final prospectus supplement relating to the securities was filed with the SEC on May 29, 2020 and are available on the SEC's website at www.sec.gov. Copies of the final prospectus supplement and the accompanying prospectus relating to the U.S. offering may be obtained for free from J.P. Morgan Securities LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, or by telephone at (866) 803-9204, or by email at ; from Cowen and Company, LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, Attn: Prospectus Department, by email at , or by telephone at (833) 297-2926; or from BofA Securities, NC1-004-03-43, 200 North College Street, 3rd floor, Charlotte, North Carolina 28255-0001, Attn: Prospectus Department, or by email at .

    In addition, argenx announces the listing of and the commencement of dealings in its 4,207,292 new ordinary shares on the regulated market of Euronext Brussels. The listing occurs pursuant to a listing prospectus approved by the Dutch regulator ("Stichting Autoriteit Financiële Markten") (the "AFM") and passported to Belgium in accordance with article 25 of Regulation (EU) 2017/1129 of the European Parliament and of the Council of 14 June 2017 on the prospectus to be published when securities are offered to the public or admitted to trading on a regulated market, and repealing Directive 2003/71/EC (as amended, the "Prospectus Regulation"). The listing prospectus, together with a Dutch translation of the summary, is available on the website of argenx (www.argenx.com) and copies may be obtained for free from argenx upon request at or by telephone at (32) 9 310 34 19 .

    This press release is for information purposes only and does not constitute, and should not be construed as, an offer to sell or the solicitation of an offer to buy or subscribe to any securities, nor shall there be any sale of securities in any jurisdiction in which such offer, solicitation or sale is not permitted or to any person or entity to whom it is unlawful to make such offer, solicitation or sale. Reference is also made to the restrictions set out in "Important information" below. This press release is not for publication or distribution, directly or indirectly, in or into any state or jurisdiction into which doing so would be unlawful or where a prior registration or approval is required for such purpose.

    About argenx

    argenx is a global immunology company developing antibody-based medicines for patients suffering from severe autoimmune diseases and cancer. By translating immunology breakthroughs into innovative drug candidates, argenx is building a world-class portfolio of first-in-class antibodies in both early and late clinical-stages of development. argenx is evaluating efgartigimod in multiple serious autoimmune indications and cusatuzumab in hematological malignancies in collaboration with Janssen, along with advancing earlier stage assets within its therapeutic franchises. 

    For further information, please contact:
    Beth DelGiacco, Vice President, Investor Relations (US)
    +1 518 424 4980

    Joke Comijn, Director Corporate Communications & Investor Relations (EU)
    +32 (0)477 77 29 44
    +32 (0)9 310 34 19

    Important information

    The preliminary prospectus supplement and final prospectus supplement in respect of the U.S. offering do not constitute a prospectus within the meaning of the Prospectus Regulation and has not been approved by the AFM or the Belgian Financial Services and Markets Authority (Autoriteit Financiële Diensten en Markten) or any other European Supervisory Authority.

    No public offering will be made and no one has taken any action that would, or is intended to, permit a public offering in any country or jurisdiction, other than the United States, where any such action is required, including in the European Economic Area. In the European Economic Area, the offering to which this press release relates will only be available to, and will be engaged in only with, qualified investors within the meaning of the Prospectus Regulation.

    European Economic Area:

    No action has been or will be taken to offer the ordinary shares to a retail investor established in the European Economic Area as part of the global offering. For the purposes of this paragraph:

    a.    The expression "retail investor" means a person who is one (or more) of:

    i.   a retail client as defined in point (11) of Article 4(1) of Directive 2014/65/EU (as amended, "MiFID II"); or
    ii.   a customer within the meaning of Directive 2016/97/EU, as amended, where that customer would not qualify as a professional client as defined in point (10) of Article 4(1) of MiFID II; or
    iii.   not a "qualified investor" as defined in the Prospectus Regulation; and

    b.    the expression "offer" means any communication in any form and by any means of sufficient information on the terms of the offer and securities to be offered so as to enable an investor to decide to purchase or subscribe these securities.

    In addition, in the United Kingdom, the transaction to which this press release relates will only be available to, and will be engaged in only with, investment professionals falling within Article 19(5) of the Financial Services and Markets Act (Financial Promotion) Order 2005, as amended (the Order), persons falling within Article 49(2)(a) to (d) of the Order, and other persons to whom this announcement may lawfully be communicated (all such persons together being referred to as "relevant persons"). The securities referred to herein are only available to, and any invitation, offer or agreement to subscribe, purchase or otherwise acquire such securities will be engaged in only with relevant persons. Any person who is not a relevant person should not act or rely on this communication or any of its contents.

    This press release is not an approved prospectus by the Financial Services Authority or by any other regulatory authority in the United Kingdom within the meaning of Section 85 of the Order. 

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  2. Regulated information — Inside information


    May 29, 2020

    Breda, the Netherlands / Ghent, Belgium — argenx ((Euronext &amp, NASDAQ:ARGX), a clinical-stage biotechnology company developing a deep pipeline of differentiated antibody-based therapies for the treatment of severe autoimmune diseases and cancer, announced today that the underwriters of its previously announced global offering of ordinary shares (including ordinary shares represented by American Depositary Shares (ADSs)) have exercised their option to purchase 548,777 additional ADSs in full on the same terms and conditions as the global offering. This option exercise brings the anticipated total gross proceeds from the global offering to approximately $862.5 million (approximately €784.7…

    Regulated information — Inside information


    May 29, 2020

    Breda, the Netherlands / Ghent, Belgium — argenx ((Euronext &amp, NASDAQ:ARGX), a clinical-stage biotechnology company developing a deep pipeline of differentiated antibody-based therapies for the treatment of severe autoimmune diseases and cancer, announced today that the underwriters of its previously announced global offering of ordinary shares (including ordinary shares represented by American Depositary Shares (ADSs)) have exercised their option to purchase 548,777 additional ADSs in full on the same terms and conditions as the global offering. This option exercise brings the anticipated total gross proceeds from the global offering to approximately $862.5 million (approximately €784.7 million) from the sale of an aggregate of 4,207,292 ordinary shares (including ordinary shares represented by ADSs).

    J.P. Morgan, Cowen and BofA Securities acted as joint bookrunning managers for the offering. Stifel, JMP Securities, Wedbush PacGrow, Nomura and Kempen & Co acted as co-managers for the offering.

    The closing of the global offering, including with respect to the ADSs subject to the option, is expected to occur on June 1, 2020, subject to customary closing conditions.

    The securities were offered in the United States pursuant to an automatically effective shelf registration statement that was previously filed with the Securities and Exchange Commission (SEC). A preliminary prospectus supplement relating to the securities was filed with the SEC on May 26, 2020. The final prospectus supplement relating to the securities will be filed with the SEC and will be available on the SEC's website at www.sec.gov. When available, copies of the final prospectus supplement and the accompanying prospectus relating to the U.S. offering may be obtained for free from J.P. Morgan Securities LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, or by telephone at (866) 803-9204, or by email at ; from Cowen and Company, LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, Attn: Prospectus Department, by email at , or by telephone at (833) 297-2926; or from BofA Securities, NC1-004-03-43, 200 North College Street, 3rd floor, Charlotte, North Carolina 28255-0001, Attn: Prospectus Department, or by email at .

    This press release is for information purposes only and does not constitute, and should not be construed as, an offer to sell or the solicitation of an offer to buy or subscribe to any securities, nor shall there be any sale of securities in any jurisdiction in which such offer, solicitation or sale is not permitted or to any person or entity to whom it is unlawful to make such offer, solicitation or sale. Reference is also made to the restrictions set out in "Important information" below. This press release is not for publication or distribution, directly or indirectly, in or into any state or jurisdiction into which doing so would be unlawful or where a prior registration or approval is required for such purpose.


    About argenx

    argenx is a global immunology company developing antibody-based medicines for patients suffering from severe autoimmune diseases and cancer. By translating immunology breakthroughs into innovative drug candidates, argenx is building a world-class portfolio of first-in-class antibodies in both early and late clinical-stages of development. argenx is evaluating efgartigimod in multiple serious autoimmune indications and cusatuzumab in hematological malignancies in collaboration with Janssen, along with advancing earlier stage assets within its therapeutic franchises. 


    For further information, please contact:

    Beth DelGiacco, Vice President, Investor Relations (US)
    +1 518 424 4980

    Joke Comijn, Director Corporate Communications & Investor Relations (EU)
    +32 (0)477 77 29 44
    +32 (0)9 310 34 19

    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 the closing of the global offering. 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 impact that the COVID-19 pandemic and resulting economic conditions will have on argenx's operations and business; argenx's expectations regarding 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.

    Important information

    The preliminary prospectus supplement in respect of the U.S. offering does not constitute a prospectus within the meaning of Regulation (EU) 2017/1129 of the European Parliament and of the Council of 14 June 2017 on the prospectus to be published when securities are offered to the public or admitted to trading on a regulated market, and repealing Directive 2003/71/EC (as amended, the "Prospectus Regulation") and has not been approved by the Dutch Authority for the Financial Markets (Stichting Autoriteit Financiële Markten) or the Belgian Financial Services and Markets Authority (Autoriteit Financiële Diensten en Markten) or any other European Supervisory Authority.

    No public offering will be made and no one has taken any action that would, or is intended to, permit a public offering in any country or jurisdiction, other than the United States, where any such action is required, including in the European Economic Area. In the European Economic Area, the offering to which this press release relates will only be available to, and will be engaged in only with, qualified investors within the meaning of the Prospectus Regulation.

    European Economic Area:

    No action has been or will be taken to offer the ordinary shares to a retail investor established in the European Economic Area as part of the global offering. For the purposes of this paragraph:

    a.    The expression "retail investor" means a person who is one (or more) of:

    i.   a retail client as defined in point (11) of Article 4(1) of Directive 2014/65/EU (as amended, "MiFID II"); or
    ii.   a customer within the meaning of Directive 2016/97/EU, as amended, where that customer would not qualify as a professional client as defined in point (10) of Article 4(1) of MiFID II; or
    iii.   not a "qualified investor" as defined in the Prospectus Regulation; and

    b.    the expression "offer" means any communication in any form and by any means of sufficient information on the terms of the offer and securities to be offered so as to enable an investor to decide to purchase or subscribe these securities.

    In addition, in the United Kingdom, the transaction to which this press release relates will only be available to, and will be engaged in only with, investment professionals falling within Article 19(5) of the Financial Services and Markets Act (Financial Promotion) Order 2005, as amended (the Order), persons falling within Article 49(2)(a) to (d) of the Order, and other persons to whom this announcement may lawfully be communicated (all such persons together being referred to as "relevant persons"). The securities referred to herein are only available to, and any invitation, offer or agreement to subscribe, purchase or otherwise acquire such securities will be engaged in only with relevant persons. Any person who is not a relevant person should not act or rely on this communication or any of its contents.

    This press release is not an approved prospectus by the Financial Services Authority or by any other regulatory authority in the United Kingdom within the meaning of Section 85 of the Order. 

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  3. Regulated information — Inside information


    May 28, 2020

    Breda, the Netherlands / Ghent, Belgium — argenx ((Euronext &amp, NASDAQ:ARGX), a clinical-stage biotechnology company developing a deep pipeline of differentiated antibody-based therapies for the treatment of severe autoimmune diseases and cancer, announced today the pricing of a global offering of ordinary shares represented by American Depository Shares (ADSs) in the United States and certain other countries outside of European Economic Area and a simultaneous private placement of ordinary shares in the European Economic Area. The Company anticipates total gross proceeds of approximately $750.0 million (approximately €682.4 million) from the sale of 2,584,138 ADSs at a price of $205.00…

    Regulated information — Inside information


    May 28, 2020

    Breda, the Netherlands / Ghent, Belgium — argenx ((Euronext &amp, NASDAQ:ARGX), a clinical-stage biotechnology company developing a deep pipeline of differentiated antibody-based therapies for the treatment of severe autoimmune diseases and cancer, announced today the pricing of a global offering of ordinary shares represented by American Depository Shares (ADSs) in the United States and certain other countries outside of European Economic Area and a simultaneous private placement of ordinary shares in the European Economic Area. The Company anticipates total gross proceeds of approximately $750.0 million (approximately €682.4 million) from the sale of 2,584,138 ADSs at a price of $205.00 per ADS and the sale of 1,074,377 ordinary shares at a price of €186.52 per ordinary share. Each of the ADSs offered in the offering represents the right to receive one ordinary share, nominal value of €0.10 per share. The U.S. offering and the European private placement are currently expected to close simultaneously on June 1, 2020, subject to customary closing conditions.

    In addition, argenx has granted the underwriters of the offering a 30-day option to purchase up to 548,777 ordinary shares (which may be represented by ADSs) on the same terms and conditions.

    argenx's ADSs are currently listed on the Nasdaq Global Select Market under the symbol "ARGX," and argenx's ordinary shares are currently listed on Euronext Brussels under the symbol "ARGX."

    J.P. Morgan, Cowen and BofA Securities are acting as joint bookrunning managers for the offering. Stifel, JMP Securities, Wedbush PacGrow, Nomura and Kempen & Co are acting as co-managers for the offering.

    The securities are being offered in the United States pursuant to an automatically effective shelf registration statement that was previously filed with the Securities and Exchange Commission (SEC). A preliminary prospectus supplement relating to the securities was filed with the SEC on May 26, 2020. The final prospectus supplement relating to the securities will be filed with the SEC and will be available on the SEC's website at www.sec.gov. When available, copies of the final prospectus supplement and the accompanying prospectus relating to the U.S. offering may be obtained for free from J.P. Morgan Securities LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, or by telephone at (866) 803-9204, or by email at ; from Cowen and Company, LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, Attn: Prospectus Department, by email at , or by telephone at (833) 297-2926; or from BofA Securities, NC1-004-03-43, 200 North College Street, 3rd floor, Charlotte, North Carolina 28255-0001, Attn: Prospectus Department, or by email at .

    A request for the admission to listing and trading of the ordinary shares (including the ordinary shares underlying the ADSs) on the regulated market of Euronext Brussels will be made. A prospectus for the listing of the ordinary shares on Euronext Brussels consisting of a universal registration document dated 31 March 2020, an amendment to the aforementioned universal registration document, a securities note and a summary (together, the "Listing Prospectus") will be filed with the Dutch regulator ("Stichting Autoriteit Financiële Markten") (the "AFM") for approval and passporting to Belgium in accordance with article 25 of Regulation (EU) 2017/1129 of the European Parliament and of the Council of 14 June 2017 on the prospectus to be published when securities are offered to the public or admitted to trading on a regulated market, and repealing Directive 2003/71/EC (as amended, the "Prospectus Regulation").  Upon approval, the Listing Prospectus together with a Dutch translation of the summary will be made available on the website of argenx (www.argenx.com) and copies may be obtained for free from argenx upon request at or by telephone at (32) 9 310 34 19.

    This press release is for information purposes only and does not constitute, and should not be construed as, an offer to sell or the solicitation of an offer to buy or subscribe to any securities, nor shall there be any sale of securities in any jurisdiction in which such offer, solicitation or sale is not permitted or to any person or entity to whom it is unlawful to make such offer, solicitation or sale. Reference is also made to the restrictions set out in "Important information" below. This press release is not for publication or distribution, directly or indirectly, in or into any state or jurisdiction into which doing so would be unlawful or where a prior registration or approval is required for such purpose.

    About argenx

    argenx is a global immunology company developing antibody-based medicines for patients suffering from severe autoimmune diseases and cancer. By translating immunology breakthroughs into innovative drug candidates, argenx is building a world-class portfolio of first-in-class antibodies in both early and late clinical-stages of development. argenx is evaluating efgartigimod in multiple serious autoimmune indications and cusatuzumab in hematological malignancies in collaboration with Janssen, along with advancing earlier stage assets within its therapeutic franchises. 

    For further information, please contact:
    Beth DelGiacco, Vice President, Investor Relations (US)
    +1 518 424 4980

    Joke Comijn, Director Corporate Communications & Investor Relations (EU)
    +32 (0)477 77 29 44
    +32 (0)9 310 34 19

    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 the anticipated total gross proceeds and closing of the proposed offering.  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 impact that the COVID-19 pandemic and resulting economic conditions will have on argenx's operations and business; argenx's expectations regarding 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 and will also be contained in the Listing Prospectus filed by argenx with the AFM in respect of the listing of the ordinary shares on Euronext Brussels . 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.

    Important information

    The preliminary prospectus supplement in respect of the U.S. offering does not constitute a prospectus within the meaning of the Prospectus Regulation and has not been approved by the AFM or the Belgian Financial Services and Markets Authority (Autoriteit Financiële Diensten en Markten) or any other European Supervisory Authority.

    No public offering will be made and no one has taken any action that would, or is intended to, permit a public offering in any country or jurisdiction, other than the United States, where any such action is required, including in the European Economic Area. In the European Economic Area, the offering to which this press release relates will only be available to, and will be engaged in only with, qualified investors within the meaning of the Prospectus Regulation.

    European Economic Area:

    No action has been or will be taken to offer the ordinary shares to a retail investor established in the European Economic Area as part of the global offering. For the purposes of this paragraph:

    a.    The expression "retail investor" means a person who is one (or more) of:

    i.   a retail client as defined in point (11) of Article 4(1) of Directive 2014/65/EU (as amended, "MiFID II"); or
    ii.   a customer within the meaning of Directive 2016/97/EU, as amended, where that customer would not qualify as a professional client as defined in point (10) of Article 4(1) of MiFID II; or
    iii.   not a "qualified investor" as defined in the Prospectus Regulation; and

    b.    the expression "offer" means any communication in any form and by any means of sufficient information on the terms of the offer and securities to be offered so as to enable an investor to decide to purchase or subscribe these securities.

    In addition, in the United Kingdom, the transaction to which this press release relates will only be available to, and will be engaged in only with, investment professionals falling within Article 19(5) of the Financial Services and Markets Act (Financial Promotion) Order 2005, as amended (the Order), persons falling within Article 49(2)(a) to (d) of the Order, and other persons to whom this announcement may lawfully be communicated (all such persons together being referred to as "relevant persons"). The securities referred to herein are only available to, and any invitation, offer or agreement to subscribe, purchase or otherwise acquire such securities will be engaged in only with relevant persons. Any person who is not a relevant person should not act or rely on this communication or any of its contents.

    This press release is not an approved prospectus by the Financial Services Authority or by any other regulatory authority in the United Kingdom within the meaning of Section 85 of the Order.

    Stabilization

    In connection with the offering, J.P. Morgan Securities LLC (the "Stabilization Manager"), or any of its agents, on behalf of the underwriters may (but will be under no obligation to), to the extent permitted by applicable law, over-allot ordinary shares or ADSs or effect other transactions with a view to supporting the market price of the ordinary shares or ADSs at a higher level than that which might otherwise prevail in the open market. The Stabilization Manager is not required to enter into such transactions and such transactions may be effected on any securities market, over-the-counter market, stock exchange (including Euronext Brussels) or otherwise and may be undertaken at any time starting on the first trading date and ending no later than 30 calendar days thereafter.

    However, there will be no obligation on the Stabilization Manager or any of its agents to effect stabilizing transactions and there is no assurance that stabilizing transactions will be undertaken. Such stabilization, if commenced, may be discontinued at any time without prior notice. Save as required by law or regulation, neither the Stabilization Manager nor any of its agents intends to disclose the extent of any over-allotments made and/or stabilization transactions under the offering.

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  4. Regulated information — Inside information


    May 26, 2020

    Breda, the Netherlands / Ghent, Belgium — argenx ((Euronext &amp, NASDAQ:ARGX), a clinical-stage biotechnology company developing a deep pipeline of differentiated antibody-based therapies for the treatment of severe autoimmune diseases and cancer, announced today that it has commenced a global offering of $500 million (approximately €458.3 million) of ordinary shares, which may be represented by American Depository Shares ("ADSs"). The global offering will be comprised of an offering of ordinary shares represented by ADSs in the United States and certain other countries outside of the European Economic Area and a simultaneous private placement of ordinary shares in the European Economic…

    Regulated information — Inside information


    May 26, 2020

    Breda, the Netherlands / Ghent, Belgium — argenx ((Euronext &amp, NASDAQ:ARGX), a clinical-stage biotechnology company developing a deep pipeline of differentiated antibody-based therapies for the treatment of severe autoimmune diseases and cancer, announced today that it has commenced a global offering of $500 million (approximately €458.3 million) of ordinary shares, which may be represented by American Depository Shares ("ADSs"). The global offering will be comprised of an offering of ordinary shares represented by ADSs in the United States and certain other countries outside of the European Economic Area and a simultaneous private placement of ordinary shares in the European Economic Area. Each of the ADSs represents the right to receive one ordinary share, nominal value of €0.10 per share. The U.S. offering and the European private placement are expected to close simultaneously.

    In addition, argenx intends to grant the underwriters of the offering a 30-day option to purchase additional ordinary shares (which may be represented by ADSs) in an aggregate amount of up to 15% of the total number of ordinary shares (including represented by ADSs) proposed to be sold in the offering, on the same terms and conditions.
      
    argenx's ADSs are currently listed on the Nasdaq Global Select Market under the symbol "ARGX." and argenx's ordinary shares are currently listed on Euronext Brussels under the symbol "ARGX.".

    J.P. Morgan, Cowen and BofA Securities are acting as joint bookrunning managers for the offering.

    The securities are being offered in the United States pursuant to an automatically effective shelf registration statement that was previously filed with the Securities and Exchange Commission ("SEC"). A preliminary prospectus supplement relating to the securities being offered in the United States will be filed with the SEC and will be available on the SEC's website at www.sec.gov.
      
    When available, copies of the preliminary prospectus supplement and the accompanying prospectus relating to these securities being offered in the United States may be obtained for free from J.P. Morgan Securities LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, or by telephone at (866) 803-9204, or by email at ; from Cowen and Company, LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, Attn: Prospectus Department, by email at , or by telephone at (833) 297-2926; or from BofA Securities, NC1-004-03-43, 200 North College Street, 3rd floor, Charlotte, North Carolina 28255-0001, Attn: Prospectus Department, or by email at .

    A request for the admission to listing and trading of the ordinary shares (including the ordinary shares underlying the ADSs) on the regulated market of Euronext Brussels will be made following pricing of the offering. A prospectus for the listing of the ordinary shares on Euronext Brussels consisting of a universal registration document dated 31 March 2020, an amendment to the aforementioned universal registration document, a securities note and a summary (together, the "Listing Prospectus") will be filed with the Dutch regulator (Stichting Autoriteit Financiële Markten) (the "AFM") for approval and passporting to Belgium in accordance with article 25 of Regulation (EU) 2017/1129 of the European Parliament and of the Council of 14 June 2017 on the prospectus to be published when securities are offered to the public or admitted to trading on a regulated market, and repealing Directive 2003/71/EC (as amended, the "Prospectus Regulation").  Upon approval, the Listing Prospectus together with a Dutch translation of the summary will be made available on the website of argenx (www.argenx.com) and copies may be obtained for free from argenx upon request at or by telephone at (32) 9 310 34 19.

    This press release is for information purposes only and does not constitute, and should not be construed as, an offer to sell or the solicitation of an offer to buy or subscribe to any securities, nor shall there be any sale of securities in any jurisdiction in which such offer, solicitation or sale is not permitted or to any person or entity to whom it is unlawful to make such offer, solicitation or sale. Reference is also made to the restrictions set out in "Important information" below. This press release is not for publication or distribution, directly or indirectly, in or into any state or jurisdiction into which doing so would be unlawful or where a prior registration or approval is required for such purpose.

    About argenx

    argenx is a global immunology company developing antibody-based medicines for patients suffering from severe autoimmune diseases and cancer. By translating immunology breakthroughs into innovative drug candidates, argenx is building a world-class portfolio of first-in-class antibodies in both early and late clinical-stages of development. argenx is evaluating efgartigimod in multiple serious autoimmune indications and cusatuzumab in hematological malignancies in collaboration with Janssen, along with advancing earlier stage assets within its therapeutic franchises.

    For further information, please contact:
    Beth DelGiacco, Vice President, Investor Relations (US)
    +1 518 424 4980

    Joke Comijn, Director Corporate Communications & Investor Relations (EU)
    +32 (0)477 77 29 44
    +32 (0)9 310 34 19

    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 the completion, timing and size of the proposed global offering and its expectations with respect to granting the underwriters a 30-day option to purchase additional ordinary shares (which may be represented by ADSs).  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 impact that the COVID-19 pandemic and resulting economic conditions will have on argenx's operations and business; argenx's expectations regarding 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 and will also be contained in the Listing Prospectus filed by argenx with the AFM in respect of the listing of the ordinary shares on Euronext Brussels. 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.

    Important information

    This announcement is not an advertisement and not a prospectus within the meaning of the Prospectus Regulation and has not been approved by the AFM or the Belgian Financial Services and Markets Authority (Autoriteit Financiële Diensten en Markten) or any other European Supervisory Authority.

    No public offering will be made and no one has taken any action that would, or is intended to, permit a public offering in any country or jurisdiction, other than the United States, where any such action is required, including in the European Economic Area. In the European Economic Area, the offering to which this press release relates will only be available to, and will be engaged in only with, qualified investors within the meaning of the Prospectus Regulation.

    European Economic Area:

    No action has been or will be taken to offer the ordinary shares to a retail investor established in the European Economic Area as part of the global offering. For the purposes of this paragraph:

    a.    The expression "retail investor" means a person who is one (or more) of:

    i.   a retail client as defined in point (11) of Article 4(1) of Directive 2014/65/EU (as amended, "MiFID II"); or
    ii.   a customer within the meaning of Directive 2016/97/EU, as amended, where that customer would not qualify as a professional client as defined in point (10) of Article 4(1) of MiFID II; or
    iii.   not a "qualified investor" as defined in the Prospectus Regulation; and

    b.    the expression "offer" means any communication in any form and by any means of sufficient information on the terms of the offer and securities to be offered so as to enable an investor to decide to purchase or subscribe these securities.

    In addition, in the United Kingdom, the transaction to which this press release relates will only be available to, and will be engaged in only with, investment professionals falling within Article 19(5) of the Financial Services and Markets Act (Financial Promotion) Order 2005, as amended (the Order), persons falling within Article 49(2)(a) to (d) of the Order, and other persons to whom this announcement may lawfully be communicated (all such persons together being referred to as "relevant persons"). The securities referred to herein are only available to, and any invitation, offer or agreement to subscribe, purchase or otherwise acquire such securities will be engaged in only with relevant persons. Any person who is not a relevant person should not act or rely on this communication or any of its contents.

    This press release is not an approved prospectus by the Financial Services Authority or by any other regulatory authority in the United Kingdom within the meaning of Section 85 of the Order.

    Stabilization

    In connection with the offering, J.P. Morgan Securities LLC (the "Stabilization Manager"), or any of its agents, on behalf of the underwriters may (but will be under no obligation to), to the extent permitted by applicable law, over-allot ordinary shares or ADSs or effect other transactions with a view to supporting the market price of the ordinary shares or ADSs at a higher level than that which might otherwise prevail in the open market. The Stabilization Manager is not required to enter into such transactions and such transactions may be effected on any securities market, over-the-counter market, stock exchange (including Euronext Brussels) or otherwise and may be undertaken at any time starting on the first trading date and ending no later than 30 calendar days thereafter.

    However, there will be no obligation on the Stabilization Manager or any of its agents to effect stabilizing transactions and there is no assurance that stabilizing transactions will be undertaken. Such stabilization, if commenced, may be discontinued at any time without prior notice. Save as required by law or regulation, neither the Stabilization Manager nor any of its agents intends to disclose the extent of any over-allotments made and/or stabilization transactions under the offering.

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  5. Regulated information – Inside information


    • Trial met primary endpoint (p ˂0.0001)
       
    • Well-tolerated; safety profile comparable to placebo
       
    • Biologics License Application on track to be submitted to U.S. Food and Drug Administration by end of 2020
       
    • Conference call scheduled for today, May 26, 2020 at 8:30 a.m. EDT (2:30 p.m. CEST)

    May 26, 2020

    Breda, the Netherlands / Ghent, Belgium
    – argenx ((Euronext &amp, NASDAQ:ARGX), a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases and cancer, today announced positive topline data from the pivotal ADAPT trial of efgartigimod. ADAPT met its primary endpoint defined as percentage of responders on the Myasthenia Gravis Activities of Daily Living…

    Regulated information – Inside information


    • Trial met primary endpoint (p ˂0.0001)
       
    • Well-tolerated; safety profile comparable to placebo
       
    • Biologics License Application on track to be submitted to U.S. Food and Drug Administration by end of 2020
       
    • Conference call scheduled for today, May 26, 2020 at 8:30 a.m. EDT (2:30 p.m. CEST)

    May 26, 2020

    Breda, the Netherlands / Ghent, Belgium
    – argenx ((Euronext &amp, NASDAQ:ARGX), a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases and cancer, today announced positive topline data from the pivotal ADAPT trial of efgartigimod. 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+) generalized myasthenia gravis (gMG) patients. Responders are defined as having at least a two-point improvement on the MG-ADL score for at least four consecutive weeks. Based on these results, argenx plans to submit a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) by the end of 2020.

    Highlights of topline ADAPT data

    • 67.7% of AChR-Ab+ patients treated with efgartigimod achieved the primary endpoint compared with 29.7% on placebo (p<0.0001).
    • 63.1% of AChR-Ab+ patients responded to efgartigimod compared with 14.1% on placebo on the Quantitative Myasthenia Gravis (QMG) score (p<0.0001); responder defined as having at least a three-point improvement on the QMG score for at least four consecutive weeks.
    • 40.0% of efgartigimod-treated AChR-Ab+ patients achieved minimal symptom expression defined as MG-ADL scores of 0 (symptom free) or 1, compared to 11.1% treated with placebo.
    • Efgartigimod was well-tolerated with a safety profile that was comparable to placebo.

    "The efgartigimod data showed rapid and robust responses in people with gMG, as well as a favorable tolerability profile," said James F. Howard Jr., M.D., Professor of Neurology (Neuromuscular Disease), Medicine and Allied Health, Department of Neurology, The University of North Carolina at Chapel Hill School of Medicine and principal investigator for the ADAPT trial. "Patients with this devastating disease can experience chronic and potentially life-threatening muscle weakness that has a major impact on their quality of life, and more treatment options are needed. These data are very encouraging as they show efgartigimod has potential to make a meaningful impact on daily living activities, and we are hopeful they will lead to a new treatment being available for the gMG community."

    "With the ADAPT trial, we set out to evaluate efgartigimod's ability to redefine the treatment paradigm for people living with gMG. The data showed that efgartigimod drove fast and deep responses, including in a proportion of patients who achieved minimal or no symptoms after treatment. In addition, we saw responses that lasted beyond eight or 12 weeks, supporting our plans to offer individualized dosing schedules that are purpose-fit to the variability in disease course that gMG patients experience," commented Wim Parys, M.D., Chief Medical Officer of argenx. "Based on these data, we intend to submit a BLA for efgartigimod to the FDA before the end of the year, taking us one step closer to potentially making efgartigimod available to patients in 2021. All of us at argenx want to thank the patients and healthcare providers who participated in the ADAPT trial. ADAPT is the first pivotal trial of efgartigimod and these data further our confidence in its broad opportunity in other severe, IgG-mediated autoimmune diseases."

    Additional ADAPT results, including secondary endpoints and prespecified analyses

    • In the ADAPT trial, the secondary endpoints listed below also demonstrated statistically significant differences in the efgartigimod arm for AChR-Ab+ patients, unless otherwise noted, compared to placebo:
      • MG-ADL responders in the overall population, including both AChR-Ab+ and AChR-antibody negative patients (p<0.0001).
      • Time on trial in clinically meaningful improvement (MG-ADL improvement ≥2) (p=0.0001).
      • Fast onset of response on MG-ADL score (onset observed in first two weeks) (p=0.0004).
      • Time to qualify for retreatment endpoint did not meet statistical significance.
         
    • In AChR-Ab+ patients who met the primary endpoint, the majority showed a sustained response, including 88.6% who achieved a response for at least six weeks, 56.8% for at least eight weeks and 34.1% for at least 12 weeks.
       
    • Of AChR-Ab+ patients who received a second treatment cycle, 70.6% were MG-ADL responders compared to 25.6% of placebo patients.
       
    • 90% of patients enrolled in the ADAPT trial continued to the ADAPT-Plus open-label extension study.
       
    • Percentage of efgartigimod responders on the MG-ADL score in the AChR-antibody negative patient population was consistent with the AChR-Ab+ patient population, but a greater placebo response was observed in this cohort.

                 

    Detailed data from the ADAPT trial will be submitted for presentation at a future medical meeting.

    Phase 3 ADAPT Trial Design

    The Phase 3 ADAPT trial was a randomized, double-blind, placebo-controlled, multi-center, global trial evaluating the safety and efficacy of efgartigimod in patients with gMG. A total of 167 adult patients with gMG in North America, Europe and Japan enrolled in the trial and were treated. Enrolled patients had a confirmed gMG diagnosis and an MG-ADL total score of five or greater. Patients were on a stable dose of at least one gMG treatment prior to randomization, including acetylcholinesterase inhibitors, corticosteroids or nonsteroidal immunosuppressive drugs, and were required to remain on that stable dose throughout the primary trial. Patients were eligible to enroll in ADAPT regardless of antibody status, including patients with AChR antibodies (AChR-Ab+) and patients where AChR antibodies were not detected. 

    Patients were randomized in a 1:1 ratio to receive efgartigimod or placebo for a total of 26 weeks as part of the primary trial. ADAPT was designed to enable an individualized treatment approach with an initial treatment cycle followed by a variable number of subsequent treatment cycles. Treatment cycles consist of four infusions of efgartigimod (10mg/kg IV) or placebo at weekly intervals. Retreatment with additional treatment cycles was initiated according to clinical response. The primary endpoint was the number of AChR-Ab+ patients who achieved a response on the MG-ADL score defined by at least a two-point improvement for four or more consecutive weeks.

    After the 26-week primary ADAPT trial, patients were eligible to roll-over into an open-label extension, ADAPT Plus. 


    About Efgartigimod

    Efgartigimod is a first-in-class 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 (MG)

    MG is a rare and chronic autoimmune disease where IgG antibodies disrupt communication between nerves and muscles, 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. Patients with confirmed AChR antibodies account for 80-90% of the total gMG population. There are approximately 65,000 people in the United States and 20,000 people in Japan living with the disease.


    Conference Call Details

    Management will host a conference call and webcast presentation today at 2:30 p.m. Central European Summer Time (CEST) / 8:30 a.m. Eastern Daylight Time (EDT). To participate in the conference call, please select your phone number below and use the confirmation code 6295982. The webcast may be accessed on the Investors page of the argenx website at www.argenx.com or by clicking here.

    Dial-in numbers:
    Please dial in 5–10 minutes prior to 2:30 p.m. CEST / 8:30 a.m. EDT using the number and conference ID below.

    Confirmation Code: 6295982

    Belgium: +32 (0)2 793 3847
    Belgium: 0800 484 71
    France: +33 (0)1 7070 0781
    France: 0805 101 465
    Netherlands: +31 (0)2 0795 6614
    Netherlands: 0800 023 5015
    UK: +44 (0) 844 481 9752
    UK: 0800 279 6619
    US: +1646 741 3167
    US: 1877 870 9135

    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 is translating 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/.

    Contacts:

    Beth DelGiacco, Vice President, Investor Relations (US)
    +1 518 424 4980

    Joke Comijn, Director Corporate Communications & Investor Relations (EU)
    +32 (0)477 77 29 44
    +32 (0)9 310 34 19

    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 the safety, tolerability and efficacy of efgartigimod and the results of the ADAPT trial; the timing of planned regulatory submissions with the FDA and, if approved, launch in the U.S.; the therapeutic and commercial potential of efgartigimod; the opportunity of efgartigimod in other severe, IgG-mediated autoimmune diseases; and the intended results of its strategy. 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 argenx's expectations regarding its the inherent uncertainties associated with competitive developments, preclinical and clinical trial and product development activities and regulatory approval requirements; failure to demonstrate the safety, tolerability and efficacy of argenx's product candidates; final and quality controlled verification of data and the related analyses; the expense and uncertainty of obtaining regulatory approval, including from the U.S. Food and Drug Administration and European Medicines Agency; the possibility of having to conduct additional clinical trials; 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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