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argenx SE (ARGX)

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Previous Close315.29
Open310.00
Bid260.00 x 800
Ask311.20 x 900
Day's Range309.18 - 314.75
52 Week Range103.75 - 316.83
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Avg. Volume154,375
Market Cap14.589B
Beta (5Y Monthly)0.86
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EPS (TTM)-1.73
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1y Target Est305.97
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  • argenx Announces 2021 Corporate Priorities and Highlights Recent Achievements Across Immunology Pipeline
    GlobeNewswire

    argenx Announces 2021 Corporate Priorities and Highlights Recent Achievements Across Immunology Pipeline

    * Submitted Biologics License Application (BLA) to U.S. Food and Drug Administration (FDA) for efgartigimod in generalized myasthenia gravis (gMG) * Initiated 50-patient gMG bridging study of subcutaneous (SC) efgartigimod based on FDA feedback * Enrolled first 30 patients, necessary for go/no-go decision, in ADHERE trial of SC efgartigimod for chronic inflammatory demyelinating polyneuropathy (CIDP) * Announced interim data from Phase 2 CULMINATE trial of cusatuzumab in development with JanssenBreda, the Netherlands – Jan. 8, 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 its 2021 corporate priorities and highlighted recent achievements from its late-stage immunology pipeline driven by its FcRn antagonist, efgartigimod. Additionally, the Company announced interim data from the Phase 2 CULMINATE trial of cusatuzumab in development with Cilag GmbH International, an affiliate of Janssen, and provided financial guidance for 2021.argenx previously announced an exclusive license agreement with Zai Lab Limited (“Zai Lab”) for the development and commercialization of efgartigimod in Greater China and the acceleration of efgartigimod development through Phase 2 proof-of-concept trials in new autoimmune indications. Zai Lab will also contribute Chinese patients to argenx’s global Phase 3 trials of efgartigimod. Under the terms of the agreement, argenx will receive $175 million in collaboration payments comprised of upfront Zai Lab equity, a guaranteed development cost-sharing payment, and a milestone payment upon U.S. efgartigimod approval. argenx will also be eligible for tiered royalties based on annual net sales of efgartigimod in Greater China.“We are excited to enter a new chapter for argenx as we look toward commercialization and achieving our mission of reaching patients with debilitating rare diseases. We’ve submitted a BLA to the FDA for efgartigimod in gMG and expect to have global efgartigimod trials ongoing this year in six indications and two formulations. We hope to continue to demonstrate the broad opportunity of our FcRn antagonist within autoimmune diseases in 2021 and beyond,” said Tim Van Hauwermeiren, Chief Executive Officer of argenx. “In parallel, establishing global commercial infrastructure within the U.S. and Japan continues to be a top priority. Now through our collaboration with Zai Lab in China and with the appointment of a general manager in Europe, we’ve solidified and accelerated our capabilities to bring efgartigimod and our future immunology candidates to patients worldwide.”2021 Corporate Priorities and Recent ProgressThe Company will continue its transition to a fully integrated immunology company by executing on three corporate priorities in 2021, including: preparation for the potential FDA approval and U.S. commercial launch of efgartigimod for the treatment of patients with gMG; the progression of its clinical-stage autoimmune pipeline; and the continued growth of its broad and differentiated pipeline through its Immunology Innovation Program.   1. Preparation for potential FDA approval and global commercial launch of efgartigimod for the treatment of patients with gMG   * Submitted BLA to FDA for efgartigimod for treatment of gMG and continued preparations for other global regulatory submissions * On track to submit application to Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) in first half of 2021 * On track to submit to European Medicines Agency (EMA) in second half of 2021 * Submission in China expected to occur shortly following potential approval in U.S.   * Initiated bridging study for SC efgartigimod in gMG based on association between total IgG reduction and clinical benefit, and feedback from the FDA. The study is a registrational, non-inferiority trial comparing the pharmacodynamic effect of 1000mg SC efgartigimod with 10mg/kg IV efgartigimod and is expected to enroll approximately 50 patients.   * Commercial preparation activities are underway and on track for potential 2021 launch, including continued engagement with key stakeholders, commercial inventory build, milestone-based hiring of field force around potential BLA acceptance and FDA approval, and development of a patient services program.   * Appointed Anant Murthy, Ph.D., as General Manager of argenx Europe. In this role, Dr. Murthy will establish the commercial infrastructure for a European launch and lead market development activities in advance of a potential European Medicines Agency (EMA) approval of efgartigimod. Dr. Murthy brings ~20 years of international experience to argenx, most recently as Head of Market Access for EMEA and Canada and the General Manager of multiple European countries for Alnylam Pharmaceuticals.   2. Progress clinical-stage autoimmune pipeline, including seven expected global trials of efgartigimod and Phase 1 trial of first-in-class C2 antibody ARGX-117   * ADVANCE (IV) and ADVANCE SC trials ongoing evaluating IV and SC efgartigimod in patients with primary immune thrombocytopenia (ITP); global program expected to support registration of both formulations   * ADDRESS registrational trial ongoing evaluating SC efgartigimod in patients with pemphigus vulgaris (PV) and pemphigus foliaceous (PF)   * ADHERE trial ongoing evaluating SC efgartigimod in chronic inflammatory demyelinating polyneuropathy (CIDP); * Completed enrollment of first 30 patients * Decision whether to expand enrollment up to 130-140 patients expected in first quarter of 2021   * Clinical trials in fifth and sixth indications of efgartigimod to begin enrollment in 2021   * Ongoing Phase 1 healthy volunteer trial of IV and SC ARGX-117, a first-in-class C2 antibody, to evaluate safety and tolerability and establish dosing regimen * Data expected in mid-2021, after which argenx plans to launch Phase 2 proof-of-concept trials in severe autoimmune diseases, including multifocal motor neuropathy (MMN)   3. Continued investment in broad and differentiated pipeline through Immunology Innovation Program   * Preclinical work ongoing in early-stage pipeline, including continued progress on ARGX-118 and ARGX-119, and the optimization of ARGX-120   * Commitment to expand pipeline at cadence of one new candidate per year from Immunology Innovation Program              Interim Data from Cusatuzumab Phase 2 CULMINATE Trial               Development of cusatuzumab in acute myeloid leukemia (AML) remains ongoing as part of a global collaboration and license agreement with Cilag GmbH International, an affiliate of Janssen.The Phase 2 CULMINATE trial (NCT04023526) is evaluating cusatuzumab in combination with azacitidine in newly-diagnosed, elderly AML patients who are ineligible for intensive chemotherapy. A total of 103 patients were randomized to receive either 10mg/kg (n=51) or 20mg/kg (n=52) cusatuzumab plus azacitidine as part of a dose identification. The 20mg/kg dose has been selected for ongoing and future trials.A pre-planned interim analysis was conducted of the 52 patients (46.2% adverse ELN risk classification) receiving 20mg/kg cusatuzumab plus azacitidine treatment (intent-to-treat population (ITT)). The results from the ITT analysis showed a complete remission (CR) rate of 27% (14/52) and composite complete remission (CRc), including CRs with incomplete hematologic recovery, rate of 40% (21/52). The 30-day mortality rate of the ITT population was 9.6% (5/52). In a cohort where patients received at least two treatment cycles (20mg/kg cusatuzumab plus azacitidine), 42% (14/33) achieved CR and 64% (21/33) achieved CRc.Cusatuzumab was observed to be well-tolerated and the safety profile was consistent with prior studies. Final results from the CULMINATE trial will be presented in a peer-reviewed forum.The decision to initiate additional studies in the development of cusatuzumab, under the collaboration, will be determined following review of data from the ongoing Phase 1b ELEVATE trial (NCT04150887), which is evaluating cusatuzumab in combination with venetoclax and azacitidine in newly-diagnosed, elderly patients with AML who are ineligible for intensive chemotherapy.Financial GuidanceAs of December 31, 2020, argenx had approximately $2.0 billion in cash, cash equivalents and current financial assets. This preliminary cash balance does not include expenses or proceeds from recently announced business development transactions, including the purchase of a priority review voucher from Bayer HealthCare Pharmaceuticals, Inc. and the exclusive license agreement with Zai Lab for efgartigimod in Greater China. 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 in 2021, 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.  J.P. Morgan Healthcare Conference Presentation and Webcastargenx CEO Tim Van Hauwermeiren, will present these updates at the virtual 39th Annual J.P. Morgan Healthcare Conference on Monday, January 11, 2020 at 8:20 a.m. ET, followed by a question and answer session.The live webcast of the presentation and question and answer session that follows may be accessed on the homepage of the argenx website at www.argenx.com. A replay of the webcast will be available for 90 days on the argenx website.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 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/.Media:Kelsey Kirk kkirk@argenx.comInvestors:Beth DelGiacco bdelgiacco@argenx.comJoke Comijn (EU) jcomijn@argenx.comForward-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, including with respect to financial guidance and cash burn; the therapeutic potential of its product candidates; the intended results of its strategy; the expected benefits of its collaborations, including with respect to the exclusive license agreement with Zai Lab; its and its collaboration partners’ clinical development and regulatory plans, including the timing, design and outcome of ongoing and planned clinical trials and preclinical activities and the timing and outcome of regulatory filings and approvals; 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.

  • The Daily Biotech Pulse: CureVac COVID-19 Vaccine Deal, Argenx Out-Licenses Neuromuscular Disorder Drug, Xencor's Oncology Collaboration
    Benzinga

    The Daily Biotech Pulse: CureVac COVID-19 Vaccine Deal, Argenx Out-Licenses Neuromuscular Disorder Drug, Xencor's Oncology Collaboration

    Here's a roundup of top developments in the biotech space over the last 24 hours:Scaling The Peaks (Biotech Stocks Hitting 52-week Highs Jan. 6) * 9 Meters Biopharma Inc (NASDAQ: NMTR) * AngioDynamics, Inc. (NASDAQ: ANGO) * Atea Pharmaceuticals, Inc. (NASDAQ: AVIR) * AxoGen, Inc Common Stock (NASDAQ: AXGN) * Axonics Modulation Technologies Inc (NASDAQ: AXNX) * BIO-TECHNE Corp (NASDAQ: TECH) * Endo International PLC (NASDAQ: ENDP) * Eyenovia Inc (NASDAQ: EYEN) * Fulgent Genetics Inc (NASDAQ: FLGT) * Genetron Holdings Ltd - ADR (NASDAQ: GTH) (announced an exclusive strategic partnership agreement for screening for kidney cancer) * Glaukos Corp (NYSE: GKOS) * Globus Medical Inc (NYSE: GMED) * Guardion Health Sciences Inc (NASDAQ: GHSI) * Hologic, Inc. (NASDAQ: HOLX) * I-Mab ADR (NASDAQ: IMAB) * Johnson & Johnson (NYSE: JNJ) * LeMaitre Vascular Inc (NASDAQ: LMAT) * Masimo Corporation (NASDAQ: MASI) * Otonomy Inc (NASDAQ: OTIC) * Pacific Biosciences of California Inc (NASDAQ: PACB) * Praxis Precision Medicines Inc (NASDAQ: PRAX) * Radius Health Inc (NASDAQ: RDUS) (announced a definitive agreement to acquire rights to Benuvia Therapeutics' synthetic cannabidiol oral solution) * Shockwave Medical Inc (NASDAQ: SWAV) * United Therapeutics Corporation (NASDAQ: UTHR) * Vericel Corp (NASDAQ: VCEL) * Zai Lab Ltd - ADR (NASDAQ: ZLAB)Down In The Dumps (Biotech Stocks Hitting 52-week Lows Jan. 6) * AbCellera Biologics Inc (NASDAQ: ABCL) * PainReform Ltd (NASDAQ: PRFX)Stocks In Focus CureVac To Collaborate With Bayer On COVID-19 Vaccine Development, Distribution CureVac BV (NASDAQ: CVAC) announced an agreement with German chemicals company Bayer AG (OTC: BAYRY) under which Bayer will support the development, supply and key territory operations of the former's COVID-19 vaccine candidate CVnCoV.Based on the collaboration agreement, CureVac will be the marketing authorization holder for the product, while Bayer will support CureVac with country operations within the European Union and selected additional markets.Bayer holds further options to become marketing authorization holder in other markets outside of Europe.In premarket trading Thursday, CureVac shares were surging 15.14% to $100. DBV To File As Domestic Issuer In US, Announces Approval For Global Restructuring Plan DBV Technologies ADR Representing 0.5 Ord Shs (NASDAQ: DBVT) said it now qualifies as a U.S. domestic issuer rather than a foreign private issuer in the U.S., and accordingly will need to file with the SEC periodic reports and registration statements on U.S. domestic issuer forms.The company also announced approval for the global restructuring plan it unveiled in June 2020 to provide operational latitude to progress the clinical development and regulatory review of investigational Viaskin Peanut in the U.S. and the European Union. The full rollout of the restructuring plan, the company said, will result in a reduction of more than 200 jobs, resulting in a remaining global team of 90 individuals.Based on assumptions regarding the progress of its regulatory dossier and in light of the final approval of the plan, DBV expects the cost reduction efforts to significantly extend its cash runway to the second half of 2022.The stock was slipping 11.33% to $3.21 in premarket trading Thursday following a 27.46% jump Wednesday.Argenx Out-Licenses Rights For Efgartigimod To Zai Lab In China Argenx SE - ADR (NASDAQ: ARGX) and Zai Lab announced an exclusive license agreement for the development and commercialization of efgartigimod in Greater China, including mainland China, Hong Kong, Taiwan and Macau.A regulatory application for the approval of efgartigimod in generalized myasthenia gravis is pending before the FDA.Argenx will receive $175 million in collaboration payments, comprised of a $75-million upfront payment in the form of 568,182 newly issued Zai Lab shares calculated at a price of $132 per share; $75 million as a guaranteed non-creditable, non-refundable development cost-sharing payment; and an additional $25-million milestone payment upon approval of efgartigimod in the U.S.Additionally, Argenx is also eligible to receive tiered royalties in the mid-teen to low-20s on a percentage basis based on annual net sales of efgartigimod in Greater China.Argenx shares were down 1.1% at $280.03 premarket Thursday.Chiasma Guides To Below-Consensus Revenue For 2020 Issuing a corporate update, Chiasma Inc (NASDAQ: CHMA) said it expects preliminary net revenues of $900,000 to $1.1 million for 2020. This is below the $1.39-million consensus estimate.The company noted that Mycapssa, which became commercially available in the U.S. late in the third quarter following approval, is getting positive feedback from endocrinologists and patients, supporting the company's goal of ultimately becoming the standard of pharmacological care in acromegaly.Coverage by Mycapssa by multiple payers, insuring about 150 million lives, provides for a solid foundation for its uptake in 2021, the company said.Chiasma is planning a regulatory filing with the European Medicines Agency in mid-2021.For 2021, the company expects operating expenses in a range of $80 million to $90 million.In after-hours trading, the stock was up 1.88% to $4.34.View more earnings on IBBRelated Link: Attention Biotech Investors: Mark Your Calendar For January PDUFA Dates Amarin Guides FY20 Revenues Below Consensus Ahead of a presentation at the JPMorgan Healthcare Conference, Amarin Corporation plc (NASDAQ: AMRN) issued a corporate update, stating that it expects full-year revenue of about $610 million, a 42% year-over-year increase. This trailed the consensus estimate of $619.19 million.The stock was trading 3.1% higher to $5.32 premarket Thursday.Pfizer Commences Late-Stage Study Of DMD Gene Therapy Pfizer Inc. (NYSE: PFE) said the first participant has been dosed in the Phase 3 CIFFREO study, which will evaluate the efficacy and safety of investigational gene therapy candidate PF-06939926 in boys with Duchenne muscular dystrophy. The CIFFREO trial is expected to enroll 99 ambulatory male patients, ages 4 through 7, across 55 clinical trial sites in 15 countries, the company said.The stock was edging up 0.43% to $37.03 in premarket trading Thursday.Xencor Enters Into Cancer R&D Collaboration With MD Anderson Xencor Inc (NASDAQ: XNCR) and the University of Texas MD Anderson Cancer Center announced a strategic R&D collaboration and commercialization agreement to develop novel CD3 bispecific antibody therapeutics for the potential treatment of patients with cancer.MD Anderson will work to identify and develop potential antibodies, collaborating with Xencor to apply its XmAb bispecific technology to create therapeutic candidates, and then conduct and fund all preclinical activities to advance candidates toward clinical studies.Xencor has certain exclusive options to license worldwide rights to develop and commercialize potential new medicines arising from the research collaboration. For programs not licensed by Xencor, Xencor will receive a portion of future payments received by MD Anderson. Xencor and MD Anderson are entering into the collaboration with two predetermined, undisclosed antibody candidates.Morphosys Appoints Sangamo Executive As CFO Morphosys Ag (NASDAQ: MOR) announced the appointment of Sung Lee as CFO effective Feb. 2, succeeding Jens Holstein, who stepped down in December. Lee will be based in Planegg, Germany.Lee is currently working as the CFO of Sangamo Therapeutics Inc (NASDAQ: SGMO).Immutep Completes Enrollment In Midstage Study Of Lead Drug In Head, Neck Cancer Immutep ADS Representing 10 Ord Shs (NASDAQ: IMMP) said it has enrolled and safely dosed the last patient for stage 2 of Part C of its TACTI-002 Phase 2 study, which is evaluating its lead product candidate, eftilagimod alpha, in combination with Merck & Co., Inc.'s (NYSE: MRK) Keytruda, in second-line head and neck squamous cell carcinoma patients.The company said it expects to report more data from TACTI-002 in the first half of 2021.The stock was rising 3.52% premarket to $3.23.Offerings Harpoon Therapeutics Inc (NASDAQ: HARP) priced its underwritten public offering of 5.882 million shares of its common stock at $17 per share for raising gross proceeds of about $100 million. The offering is expected to close on Jan. 11.The stock was down 4.67% premarket at $17.56. DermTech Inc (NASDAQ: DMTK) priced its previously announced underwritten public offering of 4.237 million shares of its common stock at $29.50 per share. The company expects to raise gross proceeds of about $125 million from the offering.The company said it intends to use the net proceeds from the offering to fund further commercialization of its clinical commercial tests, accelerate pipeline development and for general corporate purposes, including working capital and other general and administrative purposes.The stock was down 4.65% premarket to $32.98.Addex Therapeutics ADR (NASDAQ: ADXN) priced its underwritten global offering of 6 million registered shares at a public offering price of about 1.47 Swiss francs per share or $10 per ADS. Each ADS represents the right to receive six shares of Addex. The aggregate gross proceeds from the offering are expected to be $10 million. Regenxbio Inc (NASDAQ: RGNX) said it intends to sell, subject to market conditions, $175 million of its common stock in an underwritten public offering.The stock was down 0.12% premarket at $48.62. Celyad Oncology SA ADR (NASDAQ: CYAD) said it has entered into a committed equity purchase agreement for up to $40 million with Lincoln Park Capital Fund, a Chicago-based institutional investor.On The Radar Clinical Readouts Aldeyra Therapeutics Inc (NASDAQ: ALDX) is scheduled to discuss top-line symptom, redness and Schirmer's test results from the run-in cohort of the Phase 3 TRANQUILITY clinical trial in patients with dry eye disease.Earnings AngioDynamics (before the market open)Related Link: SVB Leerink Bullish On Silverback Therapeutics, Sees Diverse Pipeline See more from Benzinga * Click here for options trades from Benzinga * The Daily Biotech Pulse: Aerpio Reviews Strategic Options, Hologic Goes Shopping * The Daily Biotech Pulse: Moderna Coronavirus Vaccine Receives Third Regulatory Nod, Gritstone Rallies On Hedge Fund Stake, aTyr's COVID-19 Drug Data(C) 2021 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.

  • argenx and Zai Lab Announce Strategic Collaboration for Efgartigimod in Greater China
    GlobeNewswire

    argenx and Zai Lab Announce Strategic Collaboration for Efgartigimod in Greater China

    * Collaboration to expand and accelerate global development of efgartigimod; expected to allow argenx to more rapidly advance new potential indications into clinical development each year * Zai Lab granted exclusive rights to develop and commercialize efgartigimod in Greater China * argenx to receive $75 million in upfront Zai Lab equity and $100 million in near-term milestone and other payments            Regulated Information/Inside InformationBreda, the Netherlands, Shanghai and San Francisco – Jan. 6, 2021 – argenx SE (Euronext & NASDAQ: ARGX), a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases and cancer, and Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688), an innovative commercial-stage biopharmaceutical company, today announced an exclusive license agreement for the development and commercialization of efgartigimod in Greater China, including mainland China, Hong Kong, Taiwan and Macau.“Through this collaboration with Zai Lab, we are expanding our global footprint in one of the world’s fastest growing markets and reaching more people living with severe autoimmune diseases. By leveraging Zai Lab’s strong local expertise within Greater China and proven development capabilities, we aim to provide broad access to efgartigimod in these important markets as well as accelerate the number of autoimmune indications in clinical development,” said Tim Van Hauwermeiren, Chief Executive Officer of argenx. “We believe that Zai Lab is the ideal partner for us ahead of our first potential approval of efgartigimod in generalized myasthenia gravis (gMG) in the U.S. and we are aligned in our mutual passion to bring potential innovative immunology therapies to patients in need.”“argenx is building a leading immunology company and we are excited to collaborate with them during this important time. Efgartigimod is being evaluated in a broad range of autoimmune diseases and we look forward to bringing this potentially first-in-class product to patients in Greater China,” said Dr. Samantha Du, Founder, Chairperson and Chief Executive Officer of Zai Lab. “This collaboration also significantly expands and strengthens our pipeline in severe autoimmune diseases, where there is an urgent and serious need for new therapeutic options.”“There are an estimated 200,000 people living with MG in China,” said Dr. Harald Reinhart, Chief Medical Officer for Autoimmune and Infectious Diseases, Zai Lab. “The unmet medical need is significant for these patients, with very limited treatment options. We believe efgartigimod has a promising profile that, if approved, can potentially change the treatment paradigm not only of gMG but of other autoimmune diseases.” Under the terms of the agreement, Zai Lab obtains the exclusive right to develop and commercialize efgartigimod in Greater China. Zai Lab will recruit Chinese patients to argenx’s global registrational trials for the development of efgartigimod. Additionally, this agreement is expected to allow argenx to accelerate efgartigimod development by initiating multiple Phase 2 proof-of-concept trials in new autoimmune indications. argenx will receive $175 million in collaboration payments, comprised of a $75 million upfront payment in the form of 568,182 newly issued Zai Lab shares calculated at a price of $132.00 per share, $75 million as a guaranteed non-creditable, non-refundable development cost-sharing payment, and an additional $25 million milestone payment upon approval of efgartigimod in the U.S. argenx is also eligible to receive tiered royalties (mid-teen to low-twenties on a percentage basis) based on annual net sales of efgartigimod in Greater China.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 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/.About Zai LabZai Lab (NASDAQ:ZLAB; HKEX: 9688) is an innovative commercial-stage biopharmaceutical company focused on bringing transformative medicines for cancer and infectious and autoimmune diseases to patients in China and around the world. We aim to address significant unmet medical needs in large, fast-growing segments of the pharmaceutical market. To that end, our experienced team has secured partnerships with leading global biopharmaceutical companies in order to generate a broad pipeline of innovative marketed products and drug candidates. We have also built an in-house team with strong drug discovery and translational research capabilities and are establishing a pipeline of proprietary drug candidates with global rights. Our vision is to become a leading global biopharmaceutical company, discovering, developing, manufacturing and commercializing our portfolio in order to impact human health worldwide.For additional information about the company, please visit www.zailaboratory.com or follow us on Linkedin at https://www.linkedin.com/company/zai-lab/mycompany/ and Twitter at www.twitter.com/ZaiLab_Global.argenx ContactsMedia:Kelsey Kirk KKirk@argenx.comInvestors:Beth DelGiacco bdelgiacco@argenx.comJoke Comijn (EU) jcomijn@argenx.comZai Lab ContactsBilly Cho, CFO +86 137 6151 2501 billy.cho@zailaboratory.comMedia: Ryo Imai / Robert Flamm, Ph.D. Burns McClellan, on behalf of Zai Lab 212-213-0006 ext. 315 / 364 rimai@burnsmc.com / rflamm@burnsmc.comInvestors: Mike Zanoni Endurance Advisors, on behalf of Zai Lab 610-442-8570 mzanoni@enduranceadvisors.comargenx 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 therapeutic potential of its product candidates; the intended results of its strategy; the expected benefits of the collaboration with Zai Lab; its and its collaboration partners’ clinical development and regulatory plans, including the timing, design and outcome of ongoing and planned clinical trials and the timing and outcome of regulatory filings and approvals; 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.Zai Lab Forward-Looking StatementsThis press release contains statements about future expectations, plans and prospects for Zai Lab, including, without limitation, statements regarding the prospects of and plans for commercializing efgartigimod in Greater China. Such statements constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are not statements of historical fact nor are they guarantees or assurances of future performance. Forward-looking statements are based on Zai Lab's expectations and assumptions as of the date of this press release and are subject to inherent uncertainties, risks and changes in circumstances that may differ materially from those contemplated by the forward-looking statements. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including but not limited to (1) Zai Lab’s ability to obtain additional future funding, (2) Zai Lab’s results of clinical and pre-clinical development of its drug candidates, (3) the content and timing of decisions made by the relevant regulatory authorities regarding regulatory approvals of Zai Lab’s drug candidates, (4) Zai Lab’s ability to generate revenue from its drug candidates, (5) the effects of the novel coronavirus (COVID-19) pandemic on general economic, regulatory and political conditions and (6) other factors discussed in Zai Lab's Annual Report on Form 20-F for the fiscal year ended December 31, 2019, filed on April 29, 2020, and its other filings with the Securities and Exchange Commission. Zai Lab anticipates that subsequent events and developments will cause Zai Lab’s expectations and assumptions to change and undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as may be required by law. These forward-looking statements should not be relied upon as representing Zai Lab’s views as of any date subsequent to the date of this press release.