May 9 (Reuters) - ARGENX SE ::Q1 TOTAL OPERATING INCOME EUR 40.0 MILLION VERSUS EUR 6.9 MILLION YEAR AGO.Q1 TOTAL COMPREHENSIVE PROFIT EUR 6.7 MILLION VERSUS LOSS OF EUR 17.7 MILLION YEAR AGO.CASH, CASH EQUIVALENTS AND CURRENT FINANCIAL ASSETS TOTALED €961.6 MILLION ON MARCH 31, 2019, COMPARED TO €564.6 MILLION ON DECEMBER 31, 2018.PHASE 3 ADAPT CLINICAL TRIAL, INCLUDING ONE-YEAR OPEN-LABEL EXTENSION STUDY, IS ONGOING FOR TREATMENT OF GENERALIZED MYASTHENIA GRAVIS WITH TOPLINE DATA EXPECTED IN 2020.Q1 REVENUE EUR 36.5 MILLION VERSUS EUR 5.6 MILLION YEAR AGO.PHASE 2 PROOF-OF-CONCEPT CLINICAL TRIAL ONGOING FOR TREATMENT OF PEMPHIGUS VULGARIS; DATA EXPECTED IN 2020.PHASE 2 CLINICAL TRIAL FOR TREATMENT OF CHRONIC INFLAMMATORY DEMYELINATING POLYNEUROPATHY EXPECTED TO START IN SECOND HALF OF 2019.PHASE 1 CLINICAL TRIAL IN HEALTHY VOLUNTEERS PLANNED WITH ENHANZE SC FORMULATION OF EFGARTIGIMOD AS PART OF COLLABORATION WITH HALOZYME ANNOUNCED IN FEBRUARY 2019.FOR THE THREE MONTHS ENDED MARCH 31, 2019, FINANCIAL INCOME AMOUNTED TO €3.5 MILLION VERSUS €0.5 MILLION LAST YEAR.
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Oct 25 (Reuters) - ARGENX SE ::9-MONTH IAS 18 OPERATING LOSS EUR 49.1 MILLION VERSUS LOSS OF EUR 13.5 MILLION YEAR AGO.CASH AND CASH EQUIVALENTS AT END PERIOD EUR 582.3 MILLION VERSUS EUR 161.7 MILLION YEAR AGO.9-MONTH TOTAL COMPREHENSIVE LOSS IAS 18 EUR 38.3 MILLION VERSUS LOSS OF EUR 16.5 MILLION YEAR AGO.9-MONTH IAS 18 REVENUE EUR 17.9 MILLION VERSUS EUR 28.4 MILLION YEAR AGO.
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Sept 21 (Reuters) - ARGENX SE ::REG-ARGENX ANNOUNCES CLOSING OF U.S. PUBLIC OFFERING FOR GROSS PROCEEDS OF APPROXIMATELY $300.6 MILLION.REG-ARGENX ANNOUNCES CLOSING OF U.S. PUBLIC OFFERING FOR GROSS PROCEEDS OF APPROXIMATELY $300.6 MILLION.PRICE TO PUBLIC OF $86.50 PER ADS.GRANTED UNDERWRITERS AN OPTION TO PURCHASE UP TO AN ADDITIONAL 521,250 ADSS, REPRESENTING 15% OF ADSS SOLD.OPTION CAN BE EXERCISED DURING 30-DAY PERIOD COMMENCING SEPTEMBER 18, 2018..
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Sept 17 (Reuters) - ARGENX SE ::REG-ARGENX REPORTS POSITIVE TOPLINE RESULTS FROM PHASE 2 PROOF-OF-CONCEPT TRIAL OF EFGARTIGIMOD IN PRIMARY IMMUNE THROMBOCYTOPENIA.FAVORABLE SAFETY AND TOLERABILITY CONSISTENT WITH EFGARTIGIMOD CLINICAL TRIALS TO DATE.CLINICALLY MEANINGFUL PLATELET COUNT IMPROVEMENTS SHOWED CLEAR SEPARATION FROM PLACEBO AT INCREASING RESPONSE THRESHOLDS.PLAN TO ADVANCE ITP PROGRAM INTO PHASE 3 DEVELOPMENT.CIDP ANNOUNCED AS FOURTH INDICATION FOR EFGARTIGIMOD.ALSO EXPECTS TO INITIATE A PHASE 2 TRIAL IN ITP USING A SUBCUTANEOUS FORMULATION OF EFGARTIGIMOD.ANNOUNCED PLANS TO INITIATE A PHASE 2 PROOF-OF-CONCEPT TRIAL OF EFGARTIGIMOD (IV) IN CHRONIC INFLAMMATORY DEMYELINATING POLYNEUROPATHY (CIDP) H1 2019.
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Aug 29 (Reuters) - ARGENX SE ::REG-ARGENX RECEIVES FEEDBACK FROM JAPAN'S PMDA ON PHASE 3 CLINICAL TRIAL AND REGULATORY PATHWAY FOR EFGARTIGIMOD IN GENERALIZED MYASTHENIA GRAVIS.DATA FROM PLANNED GLOBAL PHASE 3 REGISTRATION TRIAL, IF POSITIVE, TO SERVE AS BASIS TO SUBMIT FOR MARKETING AUTHORIZATION IN JAPAN.PLANS TO INITIATE GLOBAL PHASE 3 REGISTRATION TRIAL OF EFGARTIGIMOD IN GMG BEFORE END OF 2018.EXPECTS DATA FROM PLANNED GLOBAL PHASE 3 REGISTRATION TRIAL, IF POSITIVE, WILL SERVE AS BASIS TO SUBMIT FOR MARKETING AUTHORIZATION IN JAPAN..GLOBAL PHASE 3 TRIAL EXPECTS TO ENROLL APPROXIMATELY 150 PATIENTS WITH GMG, INCLUDING PATIENTS FROM JAPAN AS WELL AS NORTH AMERICA AND EUROPE.DATA, IF POSITIVE, MAY SERVE AS BASIS FOR BIOLOGICS LICENSE APPLICATION IN U.S. BASED ON FEEDBACK FROM FDA.PATIENTS CAN ROLL OVER INTO AN OPEN-LABEL EXTENSION STUDY FOR A PERIOD OF ONE YEAR.
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July 17 (Reuters) - ARGENX SE ::REG-ARGENX RECEIVES MILESTONE PAYMENT FROM STRATEGIC COLLABORATION WITH SHIRE.HAS REACHED A PRECLINICAL MILESTONE IN ITS STRATEGIC COLLABORATION WITH SHIRE PLC.MILESTONE TRIGGERED BY SHIRE EXERCISING OPTION TO IN-LICENSE AN ANTIBODY DISCOVERED AND DEVELOPED USING CO'S SIMPLE ANTIBODY PLATFORM AND FC ENGINEERING TECHNOLOGIES.
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June 5 (Reuters) - argenx SE ::ARGENX SE SAYS EURONEXT HAS SELECTED ARGENX SE FOR INCLUSION IN BEL 20 INDEX ON EURONEXT BRUSSELS, EFFECTIVE JUNE 18, 2018.
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June 1 (Reuters) - argenx SE ::ARGENX SE FILES FOR POTENTIAL MIXED SHELF OFFERING; SIZE NOT DISCLOSED - SEC FILING.
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May 9 (Reuters) - ARGENX NV ::ARGENX REPORTS FIRST QUARTER 2018 FINANCIAL RESULTS AND PROVIDES BUSINESS UPDATE.Q1 OPERATING INCOME OF EUR 6.9 MILLION (MARCH 31, 2017: EUR 7.2 MILLION)..Q1 TOTAL COMPREHENSIVE LOSS OF EUR 17.7 MILLION (MARCH 31, 2017: EUR 8.4 MILLION).CASH POSITION OF EUR 346.6 MILLION (MARCH 31, 2017: EUR 85.0 MILLION).EXPECTED MILESTONE: PROGRESS ARGX-113 INTO PHASE 3 CLINICAL DEVELOPMENT IN GENERALIZED MG BEFORE END OF YEAR.
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April 24 (Reuters) - ARGENX NV ::REG-ARGENX TO PRESENT COMPLETE DATA FROM PHASE 2 PROOF-OF-CONCEPT TRIAL OF EFGARTIGIMOD (ARGX-113) IN GENERALIZED MYASTHENIA GRAVIS AT AMERICAN ACADEMY OF NEUROLOGY (AAN) ANNUAL MEETING.EIGHT-WEEK FOLLOW-UP DATA SHOW SEPARATION OF CLINICAL EFFICACY SCORES BETWEEN TREATMENT GROUP AND PLACEBO GROUP THROUGH DURATION OF STUDY.TOTAL AND PATHOGENIC IGG REDUCTION CORRELATES WITH DISEASE SCORE IMPROVEMENTS.
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