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FibroGen Inc (FGEN.OQ)

FGEN.OQ on NASDAQ Stock Exchange Global Select Market

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15 Jan 2019
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Latest Key Developments (Source: Significant Developments)

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

Astellas, Fibrogen Announce Topline Results From Japan Phase 3 Study Of Roxadustat
Thursday, 31 May 2018 

May 31 (Reuters) - Astellas Pharma Inc <4503.T>::ASTELLAS & FIBROGEN ANNOUNCE TOPLINE RESULTS FROM DOUBLE-BLIND JAPAN PHASE 3 STUDY FOR ROXADUSTAT IN HEMODIALYSIS CHRONIC KIDNEY DISEASE PATIENTS WITH ANEMIA.ASTELLAS PHARMA INC - FOURTH JAPAN PHASE 3 STUDY FOR ROXADUSTAT MET ITS PRIMARY ENDPOINT.ASTELLAS PHARMA INC - ROXADUSTAT WAS WELL TOLERATED IN STUDY.ASTELLAS PHARMA INC - SAFETY PROFILE OF ROXADUSTAT WAS CONSISTENT WITH THAT OBSERVED IN PREVIOUS STUDIES BOTH IN DIALYSIS AND NON-DIALYSIS PATIENTS.  Full Article

Fibrogen Inc reports Q3 loss per share $0.50
Wednesday, 8 Nov 2017 

Nov 8 (Reuters) - Fibrogen Inc ::Fibrogen reports third quarter 2017 financial results.Q3 loss per share $0.50.Q3 earnings per share view $-0.37 -- Thomson Reuters I/B/E/S.nda filing for roxadustat for anemia in​ ckd with u.s. Food and drug administration targeted for 2018.qtrly ‍total revenue $27.3 million versus $30.1 million.  Full Article

Fibrogen announces acceptance by china FDA of roxadustat NDA for treatment of anemia associated with dialysis and non-dialysis kidney disease
Wednesday, 18 Oct 2017 

Oct 18 (Reuters) - Fibrogen Inc :Fibrogen announces acceptance by china FDA of roxadustat new drug application (NDA) for treatment of anemia associated with dialysis and non-dialysis chronic kidney disease (CKD).Fibrogen - ‍under terms of Fibrogen's agreement with Astrazeneca, NDA submission triggers a $15 million milestone payment, payable to co by Astrazeneca​.  Full Article

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AstraZeneca's ovarian cancer and anaemia treatments meet goals in late-stage studies

British drugmaker AstraZeneca on Thursday said its ovarian cancer and anaemia treatments met their goals in three separate late stage trials.