News & Events:FGEN

Cibus, a leading agricultural biotechnology company, announced today the appointment of Rory Riggs, co-founder, and Chairman of Cibus, to serve as Chief Executive Officer. “Since our founding, Rory has been an important strategic partner in the success of Cibus and we are pleased that he is deepening his involvement in the company’s growth as CEO,” said Dr. Beetham.

FibroGen Inc (FGEN): * FIBROGEN ANNOUNCES POSITIVE TOPLINE RESULTS FROM PHASE 2 CLINICAL TRIAL OF ROXADUSTAT FOR THE TREATMENT OF CHEMOTHERAPY INDUCED ANEMIA. * FibroGen Inc (FGEN) - ROXADUSTAT WAS GENERALLY WELL TOLERATED Source text for Eikon: Further company coverage:

FibroGen, Inc. (FGEN) today announced positive topline results from WHITNEY, the Company’s Phase 2 clinical study of roxadustat, a first-in-class oral small molecule hypoxia-inducible factor prolyl hydroxylase inhibitor, for the treatment of chemotherapy-induced anemia.

Astellas Pharma Inc. and FibroGen, Inc. (FGEN) today announced that the European Commission has approved EVRENZO™  for the treatment of adult patients with symptomatic anemia associated with chronic kidney disease.

Astellas Pharma Inc (ALPMF): * ASTELLAS RECEIVES EUROPEAN COMMISSION APPROVAL FOR FIRST-IN-CLASS EVRENZO FOR ADULT PATIENTS WITH SYMPTOMATIC ANEMIA OF CHRONIC KIDNEY DISEASE. * EC APPROVAL OF ROXADUSTAT TRIGGERS A MILESTONE PAYMENT OF $120 MILLION BY CO TO FIBROGEN. * FIBROGEN WILL ALSO RECEIVE ROYALTIES BASED UPON EUROPEAN NET SALES Source text for Eikon: Further company coverage:

TOKYO  Astellas Pharma Inc. (ALPMF) and FibroGen, Inc. (FGEN) today announced that the European Commission has approved EVRENZO™ for the treatment of adult patients with symptomatic anemia associated with chronic kidney disease.

FibroGen Inc (FGEN): * FIBROGEN ANNOUNCES RETIREMENT OF PAT COTRONEO AND APPOINTMENT OF JUAN GRAHAM AS CHIEF FINANCIAL OFFICER. * FibroGen Inc (FGEN) - GRAHAM WAS MOST RECENTLY GLOBAL CHIEF FINANCIAL OFFICER / VICE PRESIDENT FINANCE SUPPLY CHAIN AT JOHNSON & JOHNSON INC. * FibroGen Inc (FGEN) - GRAHAM WILL BECOME CHIEF FINANCIAL OFFICER EFFECTIVE SEPTEMBER 7, 2021 Source text for Eikon: Further company coverage:

FibroGen, Inc. (FGEN) announced the retirement of Pat Cotroneo, Chief Financial Officer, and the appointment of Juan Graham in that role. “On behalf of the board, shareholders, and our employees, I want to thank Pat for his contributions as Chief Financial Officer and dedicated service over the past 21 years,” said Enrique Conterno, Chief Executive Officer, FibroGen.

AstraZeneca PLC (AZN) said Wednesday that the U.S. Food and Drug Administration has asked for an extra clinical trial of roxadustat for the treatment of anemia of chronic kidney disease before it can approve the company's new drug application. The pharmaceutical giant said that it is working with its partner FibroGen Inc. (FGEN) to evaluate the next steps.

FibroGen Inc (FGEN): * FIBROGEN RECEIVES COMPLETE RESPONSE LETTER FROM THE FDA FOR ROXADUSTAT FOR ANEMIA OF CHRONIC KIDNEY DISEASE. * FibroGen Inc (FGEN) - COMPLETE RESPONSE LETTER INDICATES FDA WILL NOT APPROVE ROXADUSTAT NDA IN ITS PRESENT FORM. * FibroGen Inc (FGEN) - FDA HAS REQUESTED ADDITIONAL CLINICAL STUDY OF ROXADUSTAT BE CONDUCTED, PRIOR TO RESUBMISSION Source text for Eikon: Further company coverage:

FibroGen Inc (FGEN) said said on Wednesday that the U.S. Food and Drug Administration has declined to approve its treatment for anemia, citing the need for an additional clinical study.

FibroGen (FGEN), Inc.  today announced that the U.S. Food and Drug Administration has issued a complete response letter regarding the New Drug Application for roxadustat for the treatment of anemia of chronic kidney disease. The letter indicates the FDA will not approve the roxadustat NDA in its present form and has requested additional clinical study of roxadustat be conducted, prior to resubmission.

FibroGen Inc (FGEN): * FIBROGEN REPORTS SECOND QUARTER 2021 FINANCIAL RESULTS. * Q2 LOSS PER SHARE $1.45. * Q2 REVENUE $24.4 MILLION. * Q2 REVENUE ESTIMATE $69.1 MILLION -- REFINITIV IBES DATA. * Q2 EARNINGS PER SHARE ESTIMATE $-0.48 -- REFINITIV IBES DATA Source text for Eikon: Further company coverage:

• Roxadustat net product revenue in China of $13.4 million, on a US GAAP basis.

FibroGen, Inc. (FGEN) will announce its second quarter 2021 financial results on Monday, August 9 after the market close. Conference Call and Audio Webcast Interested parties may access a live audio webcast of the conference call via the FibroGen (FGEN) website at https://fibrogen.gcs-web.com/events-and-presentations/events. Dial-In InformationLive: 658-9081Live: 563-8732Confirmation number: 4951789.

SUZHOU, China and SAN FRANCISCO, July 19, 2021 -- Eluminex Biosciences Limited, an ophthalmology-focused biotechnology company headquartered in Suzhou, China with a US-subsidiary office in San Francisco Bay Area, California, announced today that it has exclusively licensed global rights for the development and commercialization of an investigational biosynthetic cornea derived from recombinant ...

FibroGen, Inc. (FGEN) today announced that the U.S. Food and Drug Administration Cardiovascular and Renal Drugs Advisory Committee voted to recommend not approving roxadustat, an oral hypoxia-inducible factor prolyl hydroxylase inhibitor, for the treatment of anemia due to chronic kidney disease in adult patients.

FibroGen, Inc. (FGEN) announced the appointment of John Hunter, Ph.D., to the position of Chief Scientific Officer, where he will lead FibroGen’s research efforts, leveraging more than 20 years of global biopharmaceutical leadership and experience. “Great science and innovation are the backbone of FibroGen (FGEN) and what enable us to develop transformational medicines for patients.

Astellas Pharma Inc. and FibroGen, Inc. (FGEN) today announced the Committee for Medicinal Products for Human Use of the European Medicines Agency has adopted a positive opinion relating to the use of roxadustat for the treatment of adult patients with symptomatic anemia associated with chronic kidney disease.1 CKD impacts one in 10 people globally, of whom one in five are affected by anemia.2, 3 Ane...

SAN FRANCISCO and CAMBRIDGE, Mass., June 17, 2021 -- FibroGen, Inc. (FGEN) and HiFiBiO Therapeutics, a private, multinational clinical-stage biotherapeutics company with expertise in immune modulation and single cell science announced a partnership covering three HiFiBiO programs.