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FibroGen Inc (FGEN.OQ)

FGEN.OQ on NASDAQ Stock Exchange Global Select Market

43.50USD
2 Jul 2020
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$1.37 (+3.25%)
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Latest Key Developments (Source: Significant Developments)

Fibrogen Submits New Drug Application To The FDA For Roxadustat In Patients With Anemia Of Chronic Kidney Disease
Monday, 23 Dec 2019 

Dec 23 (Reuters) - FibroGen Inc ::FIBROGEN SUBMITS NEW DRUG APPLICATION TO THE U.S. FDA FOR ROXADUSTAT IN PATIENTS WITH ANEMIA OF CHRONIC KIDNEY DISEASE.  Full Article

Astellas Pharma Says Japan's Ministry Of Health, Labour And Welfare Approved Evrenzo(Roxadustat)
Friday, 20 Sep 2019 

Sept 20 (Reuters) - Astellas Pharma Inc <4503.T>::EVRENZO® (ROXADUSTAT) TABLETS APPROVED IN JAPAN FOR TREATMENT OF ANEMIA ASSOCIATED WITH CHRONIC KIDNEY DISEASE IN DIALYSIS PATIENTS.JAPAN'S MINISTRY OF HEALTH, LABOUR AND WELFARE APPROVED EVRENZO.APPROVAL IS BASED ON FOUR PHASE 3 STUDIES CONDUCTED IN CKD ANEMIA PATIENTS ON DIALYSIS IN JAPAN.PHASE 3 STUDIES DEMONSTRATED THAT ROXADUSTAT WAS EFFECTIVE AT RAISING HEMOGLOBIN AND THAT IT WAS WELL-TOLERATED.  Full Article

Roxadustat Approved In China For Treatment Of Anemia In Chronic Kidney Disease Patients Not Receiving Dialysis
Thursday, 22 Aug 2019 

Aug 21 (Reuters) - FibroGen Inc ::ROXADUSTAT APPROVED IN CHINA FOR TREATMENT OF ANEMIA IN CHRONIC KIDNEY DISEASE PATIENTS NOT RECEIVING DIALYSIS.FIBROGEN INC - NATIONAL MEDICAL PRODUCTS ADMINISTRATION IN CHINA HAS APPROVED EXPANSION OF MARKETING AUTHORIZATION OF ROXADUSTAT.  Full Article

Fibrogen Reports Second Quarter 2019 Financial Results
Friday, 9 Aug 2019 

Aug 8 (Reuters) - FibroGen Inc ::Q2 TOTAL REVENUE $192 MILLION .FIBROGEN REPORTS SECOND QUARTER 2019 FINANCIAL RESULTS.Q2 EARNINGS PER SHARE $1.26.Q2 EARNINGS PER SHARE ESTIMATE $-0.51 -- REFINITIV IBES DATA.Q2 REVENUE ESTIMATE $29 MILLION -- REFINITIV IBES DATA.ON TRACK TO SUBMIT U.S. NDA FOR ROXADUSTAT IN OCTOBER.AT JUNE 30 HAD $686.1 MILLION IN CASH, RESTRICTED TIME DEPOSITS, CASH EQUIVALENTS, INVESTMENTS, AND RECEIVABLES.  Full Article

FibroGen Receives Orphan Drug Designation From The U.S. FDA For Pamrevlumab For The Treatment Of Duchenne Muscular Dystrophy
Monday, 15 Apr 2019 

April 15 (Reuters) - FibroGen Inc ::FIBROGEN RECEIVES ORPHAN DRUG DESIGNATION FROM THE U.S. FDA FOR PAMREVLUMAB FOR THE TREATMENT OF DUCHENNE MUSCULAR DYSTROPHY.FIBROGEN - FDA GRANTED ORPHAN DRUG DESIGNATION FOR CO'S ANTI-CTGF ANTIBODY, PAMREVLUMAB, FOR TREATMENT OF DUCHENNE MUSCULAR DYSTROPHY.  Full Article

Fibrogen Reports Q4 Earnings Per Share Of $0.23
Thursday, 28 Feb 2019 

Feb 27 (Reuters) - FibroGen Inc ::FIBROGEN REPORTS FOURTH QUARTER AND FULL YEAR 2018 FINANCIAL RESULTS.Q4 EARNINGS PER SHARE ESTIMATE $-0.10 -- REFINITIV IBES DATA.Q4 EARNINGS PER SHARE $0.23.QTRLY TOTAL REVENUE $108.1 MILLION VERSUS $30.7 MILLION.  Full Article

Fibrogen Says Roxadustat Met All Primary Efficacy Endpoints In Three Phase 3 Trials
Thursday, 20 Dec 2018 

Dec 20 (Reuters) - FibroGen Inc ::FIBROGEN ANNOUNCES POSITIVE TOPLINE RESULTS FROM THREE GLOBAL PHASE 3 TRIALS OF ROXADUSTAT FOR TREATMENT OF ANEMIA IN PATIENTS WITH CHRONIC KIDNEY DISEASE.FIBROGEN INC - ROXADUSTAT MET ALL PRIMARY EFFICACY ENDPOINTS IN THREE GLOBAL PIVOTAL PHASE 3 TRIALS.FIBROGEN INC - U.S. AND EU PRIMARY EFFICACY ENDPOINTS WERE MET IN ALL THREE STUDIES..FIBROGEN INC - PRELIMINARY SAFETY ANALYSES OF EACH OF THESE THREE INDIVIDUAL STUDIES SHOW AN OVERALL SAFETY PROFILE.FIBROGEN INC - ADVERSE EVENTS REPORTED ARE CONSISTENT WITH THOSE EXPECTED IN THESE STUDY POPULATIONS WITH SIMILAR BACKGROUND DISEASES.FIBROGEN INC - ROXADUSTAT-TREATED PATIENTS HAD A 33% REDUCTION IN RISK OF BLOOD TRANSFUSION COMPARED TO EPOETIN ALFA.FIBROGEN INC - RESULTS OF POOLED SAFETY ANALYSES, INCLUDING MAJOR ADVERSE CARDIOVASCULAR EVENTS (MACE) FOR BOTH NDD-CKD AND DD-CKD IN GLOBAL PHASE 3.FIBROGEN - ASTRAZENECA ALSO ANNOUNCED POSITIVE TOPLINE RESULTS TODAY FROM ITS ROXADUSTAT PHASE 3 TRIALS; OLYMPUS IN NDD-CKD AND ROCKIES IN DD-CKD.  Full Article

Astellas Submits New Drug Application In Japan Of Roxadustat For Treatment Of Anemia Associated With Chronic Kidney Disease In Patients On Dialysis
Monday, 1 Oct 2018 

Oct 1 (Reuters) - FibroGen Inc ::ASTELLAS SUBMITS NEW DRUG APPLICATION IN JAPAN OF ROXADUSTAT FOR THE TREATMENT OF ANEMIA ASSOCIATED WITH CHRONIC KIDNEY DISEASE IN PATIENTS ON DIALYSIS.FIBROGEN INC - ANNOUNCED ASTELLAS SUBMITTED A NEW DRUG APPLICATION (NDA) FOR MARKETING APPROVAL IN JAPAN OF ROXADUSTAT.  Full Article

Fibrogen Receives Fast Track Designation From U.S. FDA For Pamrevlumab For Treatment Of Idiopathic Pulmonary Fibrosis
Wednesday, 12 Sep 2018 

Sept 12 (Reuters) - FibroGen Inc ::FIBROGEN RECEIVES FAST TRACK DESIGNATION FROM U.S. FDA FOR PAMREVLUMAB FOR TREATMENT OF IDIOPATHIC PULMONARY FIBROSIS.  Full Article

Fibrogen Receives Fast Track Designation From The U.S. FDA For Pamrevlumab For The Treatment Of Idiopathic Pulmonary Fibrosis
Wednesday, 12 Sep 2018 

Sept 12 (Reuters) - FibroGen Inc ::FIBROGEN RECEIVES FAST TRACK DESIGNATION FROM THE U.S. FDA FOR PAMREVLUMAB FOR THE TREATMENT OF IDIOPATHIC PULMONARY FIBROSIS.  Full Article

BRIEF-FibroGen Announces First Patient Enrolled In Pamrevlumab Clinical Trial For Acute Covid-19

* FIBROGEN ANNOUNCES FIRST PATIENT ENROLLED IN PAMREVLUMAB CLINICAL TRIAL IN PATIENTS HOSPITALIZED IN U.S. WITH ACUTE COVID-19