FGEN FibroGen Inc

43.5
+1.37  (+3%)
Previous Close 42.13
Open 42.89
52 Week Low 22.65
52 Week High 48.95
Market Cap $3,876,056,756
Shares 89,104,753
Float 77,666,840
Enterprise Value $3,265,495,243
Volume 537,991
Av. Daily Volume 785,287
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Upcoming Catalysts

Drug Stage Catalyst Date
Roxadustat
Anaemia in Chronic Kidney Disease
PDUFA
PDUFA
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Roxadustat
Myelodysplastic syndromes (MDS)
Phase 3
Phase 3
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Drug Pipeline

Drug Stage Notes
Pamrevlumab
COVID-19
Phase 2
Phase 2
Phase 2 commencement of enrolment announced June 23, 2020.
Pamrevlumab - Borea
COVID-19
Phase 2/3
Phase 2/3
Phase 2/3 commencement of enrolment in Italy trial announced June 8, 2020.
Pamrevlumab (FG-3019) - ZEPHYRUS
Idiopathic pulmonary fibrosis
Phase 3
Phase 3
Phase 3 trial initiation announced July 22, 2019. Enrolment paused due to COVID-19.
Pamrevlumab FG-3019
Duchenne muscular dystrophy
Phase 2
Phase 2
Phase 3 trial to be initiated 2H 2020.
Pamrevlumab (FG-3019)
Pancreatic cancer
Phase 3
Phase 3
Phase 3 initiation of dosing announced October 23, 2019.
Roxadustat
Chemotherapy-induced anemia (CIA)
Phase 2
Phase 2
Phase 2 trial initiation announced September 26, 2019.

Latest News

  1. SAN FRANCISCO, June 23, 2020 (GLOBE NEWSWIRE) -- FibroGen, Inc. (NASDAQ:FGEN) today announced the initiation of a randomized, double-blind, placebo-controlled Phase 2 Study investigating the efficacy and safety of pamrevlumab in hospitalized patients with acute coronavirus 2019 (COVID-19) infection. This multicenter trial is being conducted in the U.S. and will enroll approximately 130 patients with COVID-19.

    The primary objective of this study is to assess the effect of pamrevlumab on blood oxygenation in patients with COVID-19 infection, and patients will be randomized to treatment with pamrevlumab or standard of care in a 1:1 ratio. The primary efficacy assessment is the proportion of hospitalized COVID-19 patients who have not received…

    SAN FRANCISCO, June 23, 2020 (GLOBE NEWSWIRE) -- FibroGen, Inc. (NASDAQ:FGEN) today announced the initiation of a randomized, double-blind, placebo-controlled Phase 2 Study investigating the efficacy and safety of pamrevlumab in hospitalized patients with acute coronavirus 2019 (COVID-19) infection. This multicenter trial is being conducted in the U.S. and will enroll approximately 130 patients with COVID-19.

    The primary objective of this study is to assess the effect of pamrevlumab on blood oxygenation in patients with COVID-19 infection, and patients will be randomized to treatment with pamrevlumab or standard of care in a 1:1 ratio. The primary efficacy assessment is the proportion of hospitalized COVID-19 patients who have not received mechanical ventilation and/or extracorporeal membrane oxygenation (ECMO) and remain alive at Day 28.

    "The majority of patients with severe forms of COVID-19 have bilateral interstitial pneumonia, causing reduction in oxygenation and severe respiratory failure," said Elias Kouchakji, M.D., Senior Vice President, Clinical Development, Drug Safety, and Pharmacovigilance, FibroGen. "The administration of pamrevlumab, a first-in-class anti-connective growth factor monoclonal antibody, could protect the lung from the immediate consequences of the infection presented as acute respiratory distress syndrome."

    A second planned U.S. trial is expected to assess the longer term efficacy and safety of pamrevlumab in patients who have recovered or are recovering from COVID-19 infection with evidence of interstitial lung disease.   

    Pamrevlumab is a first-in-class antibody developed by FibroGen to inhibit the activity of CTGF, a common factor in fibrotic and proliferative disorders characterized by persistent and excessive scarring that can lead to organ dysfunction and failure. This trial will assess pamrevlumab's effect on patient time to and on ventilatory support, currently the most urgent need, and its potential to reduce mortality and fibrotic sequelae in the lung.

    "Given our expertise in CTGF biology and the potential application of this unique approach to the treatment of patients with acute COVID-19 infection, we are excited to begin enrolling this trial in the U.S." said Enrique Conterno, Chief Executive Officer, FibroGen. "We are grateful for the collaboration of the FDA, investigators, and patients in enabling the conduct of this trial."

    About Pamrevlumab

    Pamrevlumab is a first-in-class antibody developed by FibroGen that inhibits the activity of connective tissue growth factor (CTGF), a common factor in fibrotic and proliferative disorders. Pamrevlumab is in Phase 3 clinical development for the treatment of idiopathic pulmonary fibrosis (IPF) and locally advanced unresectable pancreatic cancer (LAPC), and in Phase 2 clinical development for the treatment of Duchenne muscular dystrophy (DMD) and coronavirus (COVID-19). For information about pamrevlumab studies currently recruiting patients, please visit www.clinicaltrials.gov.

    About FibroGen

    FibroGen, Inc. is a biopharmaceutical company committed to discovering, developing and commercializing a pipeline of first-in-class therapeutics. The company applies its pioneering expertise in hypoxia-inducible factor (HIF) and connective tissue growth factor (CTGF) biology to advance innovative medicines to treat unmet needs. The Company is currently developing and commercializing roxadustat, an oral small molecule inhibitor of HIF prolyl hydroxylase activity, for anemia associated with chronic kidney disease (CKD). Roxadustat is also in clinical development for anemia associated with myelodysplastic syndromes (MDS) and for chemotherapy-induced anemia. Pamrevlumab, an anti-CTGF human monoclonal antibody, is in clinical development for the treatment of idiopathic pulmonary fibrosis (IPF), locally advanced unresectable pancreatic cancer, Duchenne muscular dystrophy (DMD), and coronavirus (COVID-19). For more information, please visit www.fibrogen.com.

    Forward-Looking Statements

    This release contains forward-looking statements regarding our strategy, future plans and prospects, including statements regarding the development and commercialization of the company's product candidates, the potential safety and efficacy profile of our product candidates, our clinical programs and regulatory events, and those of our partners. These forward-looking statements include, but are not limited to, statements about our plans, objectives, representations and contentions and are not historical facts and typically are identified by use of terms such as "may," "will", "should," "on track," "could," "expect," "plan," "anticipate," "believe," "estimate," "predict," "potential," "continue" and similar words, although some forward-looking statements are expressed differently. Our actual results may differ materially from those indicated in these forward-looking statements due to risks and uncertainties related to the continued progress and timing of our various programs, including the enrollment and results from ongoing and potential future clinical trials, and other matters that are described in our Annual Report on Form 10-K for the fiscal year ended December 31, 2019, and our Quarterly Report on Form 10-Q for quarter ended March 31, 2020, filed with the Securities and Exchange Commission (SEC), including the risk factors set forth therein. Investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this release, and we undertake no obligation to update any forward-looking statement in this press release, except as required by law.

    Contact:

    FibroGen, Inc.

    Media Inquiries:

    Sara Iacovino

    1.703.474.4452

    Investors:

    Michael Tung, M.D.

    Corporate Strategy / Investor Relations

    1.415.978.1434

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  2. SAN FRANCISCO, June 22, 2020 (GLOBE NEWSWIRE) -- FibroGen, Inc. (NASDAQ:FGEN) announced the appointment of Thane Wettig to the newly-created position of Chief Commercial Officer, where he will lead FibroGen's commercialization efforts, leveraging more than 30 years of global biopharmaceutical leadership and experience.

    "I am excited to welcome Thane to FibroGen as our new Chief Commercial Officer," said Enrique Conterno, Chief Executive Officer, FibroGen. "Thane's expertise, experience and track-record for results make him the ideal person to lead FibroGen's commercial operations. I look forward to his leadership impact in working with our partners to ensure roxadustat's commercial success and to realize the potential of pamrevlumab across…

    SAN FRANCISCO, June 22, 2020 (GLOBE NEWSWIRE) -- FibroGen, Inc. (NASDAQ:FGEN) announced the appointment of Thane Wettig to the newly-created position of Chief Commercial Officer, where he will lead FibroGen's commercialization efforts, leveraging more than 30 years of global biopharmaceutical leadership and experience.

    "I am excited to welcome Thane to FibroGen as our new Chief Commercial Officer," said Enrique Conterno, Chief Executive Officer, FibroGen. "Thane's expertise, experience and track-record for results make him the ideal person to lead FibroGen's commercial operations. I look forward to his leadership impact in working with our partners to ensure roxadustat's commercial success and to realize the potential of pamrevlumab across several high-value indications."

    Mr. Wettig most recently served as Chief Commercial Officer and Metabolic Franchise Head at Intarcia Therapeutics. Prior to joining Intarcia in 2018, Thane spent more than 27 years at Lilly in roles of increasing responsibility, where he served as Vice President of Global Marketing, Strategy and Alliance Management for Lilly Diabetes, leading the development and launch of multiple blockbuster diabetes medicines during a period of unprecedented growth of Lilly's diabetes business. Thane also played an integral role in the design and management of Lilly's highly successful diabetes alliance.

    Thane began his career at Lilly in sales, had additional experiences in business development, sales operations, marketing – U.S. and Global, before serving as Vice President of Global Marketing for Lilly Diabetes. He is recognized throughout the industry as a seasoned executive with extensive launch experience. Mr. Wettig received his M.B.A. and B.A. in biology from Washington University in St. Louis.

    "I'm thrilled to be joining FibroGen at such an exciting time for the company and I'm looking forward to working closely with our partners, AstraZeneca and Astellas, to ensure roxadustat can reach as many chronic kidney disease patients with anemia as possible on a worldwide basis," said Thane Wettig, Chief Commercial Officer, FibroGen. "In addition, I look forward to building and leading the commercial organization as we accelerate brand development and, ultimately, global commercialization activities for pamrevlumab. I am excited to once again be working with Enrique, as well as the entire FibroGen team."

    About FibroGen

    FibroGen, Inc. is a biopharmaceutical company committed to discovering, developing and commercializing a pipeline of first-in-class therapeutics. The company applies its pioneering expertise in hypoxia-inducible factor (HIF) and connective tissue growth factor (CTGF) biology to advance innovative medicines to treat unmet needs. The Company is currently developing and commercializing roxadustat, an oral small molecule inhibitor of HIF prolyl hydroxylase activity, for anemia associated with chronic kidney disease (CKD). Roxadustat is also in clinical development for anemia associated with myelodysplastic syndromes (MDS) and for chemotherapy-induced anemia. Pamrevlumab, an anti-CTGF human monoclonal antibody, is in clinical development for the treatment of idiopathic pulmonary fibrosis (IPF), locally advanced unresectable pancreatic cancer, Duchenne muscular dystrophy (DMD), and coronavirus (COVID-19). For more information, please visit www.fibrogen.com.

    Forward-Looking Statements

    This release contains forward-looking statements regarding our strategy, future plans and prospects, including statements regarding the development and commercialization of the company's product candidates. These forward-looking statements include, but are not limited to, statements about our plans, objectives, representations and contentions and are not historical facts and typically are identified by use of terms such as "may," "will", "should," "on track," "could," "expect," "plan," "anticipate," "believe," "estimate," "predict," "potential," "continue" and similar words, although some forward-looking statements are expressed differently. Our actual results may differ materially from those indicated in these forward-looking statements due to risks and uncertainties related to the continued progress and timing of our various programs, including the enrollment and results from ongoing and potential future clinical trials, and other matters that are described in our Annual Report on Form 10-K for the fiscal year ended December 31, 2019 and our Quarterly Report on Form 10-Q for quarter ended March 31, 2020 filed with the Securities and Exchange Commission (SEC), including the risk factors set forth therein. Investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this release, and we undertake no obligation to update any forward-looking statement in this press release, except as required by law.

    Contact:

    FibroGen, Inc.

    Media Inquiries:

    Sara Iacovino

    1.703.474.4452

    Investors:

    Michael Tung, M.D.

    Corporate Strategy / Investor Relations

    1.415.978.1434

     

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    • Roxadustat demonstrates non-inferiority to darbepoetin alfa in achievement of Hb correction in DOLOMITES Phase 3 study of anemia in non-dialysis dependent patients with chronic kidney disease

    SAN FRANCISCO, June 08, 2020 (GLOBE NEWSWIRE) -- FibroGen, Inc. (NASDAQ:FGEN) announced data from three roxadustat clinical trials, including the Phase 3 DOLOMITES study evaluating roxadustat for treatment of anemia in non-dialysis-dependent CKD patients compared to darbepoetin alfa, and ophthalmology findings from a Japan Phase 3 study evaluating roxadustat compared to darbepoetin alfa in patients on hemodialysis 1. These data were presented in virtual oral sessions of the 57th European Renal Association-European Dialysis and Transplant Association (ERA-EDTA…

    • Roxadustat demonstrates non-inferiority to darbepoetin alfa in achievement of Hb correction in DOLOMITES Phase 3 study of anemia in non-dialysis dependent patients with chronic kidney disease

    SAN FRANCISCO, June 08, 2020 (GLOBE NEWSWIRE) -- FibroGen, Inc. (NASDAQ:FGEN) announced data from three roxadustat clinical trials, including the Phase 3 DOLOMITES study evaluating roxadustat for treatment of anemia in non-dialysis-dependent CKD patients compared to darbepoetin alfa, and ophthalmology findings from a Japan Phase 3 study evaluating roxadustat compared to darbepoetin alfa in patients on hemodialysis 1. These data were presented in virtual oral sessions of the 57th European Renal Association-European Dialysis and Transplant Association (ERA-EDTA) Virtual Congress, taking place June 6 - 9, 2020. These trials were conducted by Astellas Pharma, Inc., FibroGen's collaboration partner for roxadustat in Europe, Japan and certain other markets.

    The Phase 3 DOLOMITES study evaluated the efficacy and safety of roxadustat compared to darbepoetin alfa for the treatment of anemia in non-dialysis dependent (NDD) patients with stage 3 - 5 chronic kidney disease (CKD). In the primary endpoint analysis, the study demonstrated non-inferiority of roxadustat to darbepoetin alfa in the proportion of patients achieving correction of hemoglobin (Hb) levels during the first 24 weeks of treatment (89.5% vs 78.0%; a difference of 11.51% [95% confidence interval (CI): 5.66%, 17.36%]), with a lower bound of 95% confidence interval >0%. The response in correction of hemoglobin levels was defined as achieving Hb ≥11g/dL and Hb increase from baseline of ≥1g/dL with baseline Hb >8g/dL, or Hb increase from baseline of ≥2.0 g/dL in patients with baseline Hb ≤8.0 g/dL.

    Secondary endpoints were hierarchically tested for non-inferiority and superiority. Roxadustat was superior to darbepoetin alfa in decreasing low-density lipoprotein cholesterol with a least square mean (LSM) difference of -0.403 mmol/L (95% CI -0.510, -0.296; [P<0.01]) and superior in time to first intravenous iron use with a hazard ratio (HR) of 0.45 (95% CI: 0.26, 0.78; [P=0.004]). The non-inferiority of roxadustat to darbepoetin alfa on hypertension risk was demonstrated for mean arterial pressure change from baseline to weeks 12-28 with a LSM difference of -0.372 mmHg (95% CI: -1.587, 0.842) and time to occurrence of hypertension HR 0.83 (95% CI: 0.56, 1.22). Regarding safety, the overall incidence of treatment-emergent adverse events was comparable between roxadustat and darbepoetin alfa (91.6% and 92.5%, respectively).

    With a relatively small sample size (roxadustat n=323, darbepoetin n=293), non-confirmatory analysis of adjudicated major adverse cardiovascular events (MACE), and MACE plus hospitalized unstable angina and hospitalized congestive heart failure (MACE+) outcomes showed HR point estimates of 0.81 (95% CI: 0.52, 1.25) and 0.90 (95% CI: 0.61, 1.32).

    "The goal of treatment for anemia in CKD is to ensure sufficient oxygenation to vital organs in the body. The vast majority of CKD patients, however, continue to suffer from moderate to severe anemia with low hemoglobin levels which are associated with a higher risk of blood transfusions and with debilitating symptoms that can make daily activities extremely challenging," said K. Peony Yu, M.D., Chief Medical Officer, FibroGen. "The results for roxadustat presented at this year's ERA-EDTA meeting represent the breadth of our clinical development program and our commitment to the continued evaluation of roxadustat as a potential treatment for anemia in chronic kidney disease across a spectrum of patients and treatment settings." 

    "The DOLOMITES data adds to the comprehensive body of evidence supporting the safety and efficacy of roxadustat in adult chronic kidney disease patients with anemia who are non-dialysis dependent (NDD)," said Enrique Conterno, Chief Executive Officer, FibroGen. "The studies presented at the ERA-EDTA Virtual Congress 2020 reinforce our commitment to turning innovative science into valued therapeutic medicines for patients."

    Ophthalmological effects of roxadustat from a Phase 3, randomized, double-blind, active-comparator study in Japanese patients on dialysis converted from ESA therapy (Study 1517-CL-307) 2 were also presented at the ERA-EDTA Virtual Congress 2020. The primary endpoint of the study was achieved as roxadustat maintained hemoglobin within 10–12 g/dL in patients on hemodialysis and was non-inferior to darbepoetin alfa. Treatment-emergent adverse events were consistent with previous reports and overall study results were recently published in the Journal of the American Society of Nephrology. This presentation at ERA-EDTA focused on a prospective analysis of ophthalmological/retinal-related events observed during this Phase 3 study. During the 24-week treatment period, these data suggest that dialysis dependent CKD patients who were treated with roxadustat were not at an increased risk of ophthalmic abnormalities, compared with patients treated with darbepoetin alfa. This includes retinal hemorrhages or increased retinal thickness.

    About the DOLOMITES Trial (Abstract MO001)

    DOLOMITES is a Phase 3, randomized, open-label, active-controlled study to evaluate the efficacy and safety of roxadustat in comparison to darbepoetin alfa in the treatment of anemia in adult NDD CKD patients. The study enrolled 616 adult anemia patients with stage 3-5 CKD, of which 323 received roxadustat and 293 received darbepoetin alfa. The response in correction of hemoglobin levels was defined as achieving Hb ≥11g/dL and Hb increase from baseline of ≥1g/dL with baseline Hb >8g/dL, or Hb increase from baseline of ≥2.0 g/dL in patients with baseline Hb ≤8.0 g/dL. For more information about this study, visit www.clinicaltrials.gov [NCT02021318].

    About Study 1517-CL-0307 (Abstract MO002)

    Study 1517-CL-0307 is a Phase 3, randomized, double-blind, active-controlled clinical trial, conducted at 58 Japanese sites to evaluate the non-inferiority of roxadustat to darbepoetin alfa when both drugs are titrated to maintain Hb levels of 10-12g/dL in Japanese CKD patients on hemodialysis. The study randomized 303 patients to receive either roxadustat (n=151) or darbepoetin alfa (n=152) for 24 weeks. The safety of roxadustat was assessed by monitoring treatment emergent adverse events and through detailed ophthalmologic investigations, including adjudicated examination of retinal vascular findings before and after treatment. For more information about this study, visit www.clinicaltrials.gov. [NCT02952092].

    About Anemia Associated with CKD

    Chronic kidney disease (CKD) is generally a progressive disease characterized by gradual loss of kidney function that may eventually lead to kidney failure or end stage renal disease, requiring dialysis or kidney transplant. CKD is estimated to occur in approximately 10-12% of adults worldwide3 and is predicted to become the fifth most common cause of premature death globally by 2040.4

    Anemia, a serious medical condition in which patients have insufficient red blood cells and low levels of hemoglobin, is a common early complication of CKD,5 affecting approximately 20% of CKD patients.6 Anemia in CKD is associated with an increased risk of hospitalization, cardiovascular complications and death, and can also cause significant fatigue, cognitive dysfunction and reduced quality of life. Blood transfusions are used for treating severe anemia, however, they may reduce a patient's opportunity for kidney transplant and can increase the risk of infection and/or complications such as heart failure and allergic reactions.

    About Roxadustat

    Roxadustat is a first-in-class, orally administered small molecule HIF-PH inhibitor that promotes erythropoiesis through increasing endogenous production of erythropoietin, and improved iron absorption, transport and mobilization. Roxadustat is approved in China for the treatment of anemia in CKD patients on dialysis and patients not on dialysis, and is approved in Japan for the treatment of anemia in CKD patients on dialysis, and a supplemental NDA for the treatment of anemia in CKD patients not on dialysis is under regulatory review. The roxadustat NDA for the treatment of anemia in CKD is under review by the U.S. Food and Drug Administration with a Prescription Drug User Fee Act date of December 20, 2020. The Marketing Authorization Application for roxadustat for the treatment of anemia in CKD was filed by our partner Astellas and accepted by the European Medicines Agency for review on May 21, 2020. Roxadustat is also in clinical development for anemia associated with myelodysplastic syndromes (MDS) and for chemotherapy-induced anemia.

    Astellas and FibroGen are collaborating on the development and commercialization of roxadustat for the treatment of anemia in territories including Japan and Europe. AstraZeneca and FibroGen are collaborating on the development and commercialization of roxadustat for the treatment of anemia in the U.S., China, and other markets.

    About FibroGen

    FibroGen, Inc. is a biopharmaceutical company committed to discovering, developing and commercializing a pipeline of first-in-class therapeutics. The company applies its pioneering expertise in hypoxia-inducible factor (HIF) and connective tissue growth factor (CTGF) biology to advance innovative medicines to treat unmet needs. The Company is currently developing and commercializing roxadustat, an oral small molecule inhibitor of HIF prolyl hydroxylase activity, for anemia associated with chronic kidney disease (CKD). Roxadustat is also in clinical development for anemia associated with myelodysplastic syndromes (MDS) and for chemotherapy-induced anemia. Pamrevlumab, an anti-CTGF human monoclonal antibody, is in clinical development for the treatment of idiopathic pulmonary fibrosis (IPF), locally advanced unresectable pancreatic cancer, and Duchenne muscular dystrophy (DMD). For more information, please visit www.fibrogen.com.

    Forward-Looking Statements

    This release contains forward-looking statements regarding our strategy, future plans and prospects, including statements regarding the development and commercialization of the company's product candidates, the potential safety and efficacy profile of our product candidates, our clinical programs and regulatory events, and those of our partners. These forward-looking statements include, but are not limited to, statements about our plans, objectives, representations and contentions and are not historical facts and typically are identified by use of terms such as "may," "will", "should," "on track," "could," "expect," "plan," "anticipate," "believe," "estimate," "predict," "potential," "continue" and similar words, although some forward-looking statements are expressed differently. Our actual results may differ materially from those indicated in these forward-looking statements due to risks and uncertainties related to the continued progress and timing of our various programs, including the enrollment and results from ongoing and potential future clinical trials, and other matters that are described in our Annual Report on Form 10-K for the fiscal year ended December 31, 2019 and our Quarterly Report on Form 10-Q for quarter ended March 31, 2020 filed with the Securities and Exchange Commission (SEC), including the risk factors set forth therein. Investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this release, and we undertake no obligation to update any forward-looking statement in this press release, except as required by law.

    Contacts:

    FibroGen, Inc.

    Media:

    Sara Iacovino

    1.703.474.4452

    Investors:

    Michael Tung, M.D.

    Investor Relations

    1.415.978.1434

    References

    1. Clinicaltrials.gov. Roxadustat in the Treatment of Anemia in Chronic Kidney Disease (CKD) Patients, Not on Dialysis, in Comparison to Darbepoetin Alfa (Dolomites). Available from: https://clinicaltrials.gov/ct2/show/NCT02021318 [Last accessed: June 2020].
    2. Clinicaltrials.gov. A Phase 3, Multi-center, Randomized, 2-arm Parallel, Double-blind, Active-comparator (Darbepoetin Alfa) Conversion Study of Intermittent Oral Dosing of ASP1517 in Hemodialysis Chronic Kidney Disease Patients with Anemia. Available from: https://clinicaltrials.gov/ct2/show/NCT02952092 [Last accessed: June 2020].
    3. International Society of Nephrology. Chronic kidney disease. Global kidney health atlas. Available from: www.theisn.org/global-atlas [Last accessed: January 2020].
    4. Institute for Health Metrics and Evaluation (IHME). Findings from the Global Burden of Disease Study 2017. Seattle, WA: IHME, 2018. Available from: http://www.healthdata.org/sites/default/files/files/policy_report/2019/GBD_2017_Booklet.pdf [Last accessed: January 2020].
    5. McClellan W, Aronoff SL, Bolton WK, et al. The prevalence of anemia in patients with chronic kidney disease. Curr Med Res Opin 2004;20:1501–1510.
    6. Dmitrieva O, de Lusignan S, Macdougall IC, et al. Association of anaemia in primary care patients with chronic kidney disease: cross sectional study of quality improvement in chronic kidney disease (QICKD) trial data. BMC Nephrol 2013;14:24.

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  3. SAN FRANCISCO, June 08, 2020 (GLOBE NEWSWIRE) -- FibroGen, Inc. (NASDAQ:FGEN) today announced the initiation of an open-label, randomized, parallel-arm study investigating the efficacy and safety of pamrevlumab versus standard of care in patients with severe coronavirus 2019 (COVID-19) infection. The trial is being conducted by Professor Luca Richeldi, M.D., Ph.D., Head of the Division of Pulmonary Medicine at Fondazione Policlinico Universitario A. Gemelli IRCCS, and Professor of Respiratory Medicine at Catholic University of the Sacred Heart in Rome, Italy.

    BOREA is a Phase 2/3 investigator-initiated clinical trial investigating the efficacy and safety of pamrevlumab in approximately 68 patients hospitalized with COVID-19. The primary…

    SAN FRANCISCO, June 08, 2020 (GLOBE NEWSWIRE) -- FibroGen, Inc. (NASDAQ:FGEN) today announced the initiation of an open-label, randomized, parallel-arm study investigating the efficacy and safety of pamrevlumab versus standard of care in patients with severe coronavirus 2019 (COVID-19) infection. The trial is being conducted by Professor Luca Richeldi, M.D., Ph.D., Head of the Division of Pulmonary Medicine at Fondazione Policlinico Universitario A. Gemelli IRCCS, and Professor of Respiratory Medicine at Catholic University of the Sacred Heart in Rome, Italy.

    BOREA is a Phase 2/3 investigator-initiated clinical trial investigating the efficacy and safety of pamrevlumab in approximately 68 patients hospitalized with COVID-19. The primary objective of this study is to assess the effect of pamrevlumab on blood oxygenation in patients with COVID-19 infection. Patients will be randomized to treatment with pamrevlumab or standard of care in a 1:1 ratio. Based on the investigator's decision, a subgroup of patients may continue treatment for up to 12 weeks.

    "Recent data indicate the presence of interstitial pneumonia in the majority of hospitalized patients infected with COVID-19. The interstitial pneumonia is usually bilateral and leads to decreased blood oxygen levels, respiratory failure, intubation, and, ultimately, death in a significant proportion of patients who require mechanical ventilation," said Elias Kouchakji, M.D., Senior Vice President, Clinical Development, Drug Safety, and Pharmacovigilance, FibroGen. "Connective tissue growth factor (CTGF) may promote vascular leakage and lead to pulmonary edema. Administration of pamrevlumab, an anti-CTGF monoclonal antibody, may reverse this edema, and thus improve oxygenation in patients with COVID-19-induced pneumonia."

    Pamrevlumab is a first-in-class antibody developed by FibroGen to inhibit the activity of CTGF, a common factor in fibrotic and proliferative disorders characterized by persistent and excessive scarring that can lead to organ dysfunction and failure. This trial will assess pamrevlumab's effect on patient time to and on ventilatory support, currently the most urgent need, and its potential to reduce mortality and fibrotic sequelae in the lung.

    FibroGen today also announced the planned initiation of two additional randomized, double-blind, placebo-controlled Phase 2 studies investigating the efficacy and safety of pamrevlumab versus standard of care in patients with severe COVID-19 infection in the United States.

    • The Investigational New Drug (IND) application for the first trial has been approved by the U.S. Food and Drug Administration (FDA), and it will assess the efficacy and safety of pamrevlumab in approximately 130 patients hospitalized with COVID-19 in the acute setting.

    ° This is a randomized, double-blind, placebo-controlled study, to assess the efficacy and safety of pamrevlumab in hospitalized patients with acute COVID-19 infection, in a 1:1 ratio.

    ° The primary efficacy assessment is the proportion of hospitalized COVID-19 patients who never receive mechanical ventilation and/or extracorporeal membrane oxygenation (ECMO) and remain alive at day 28.

    • The second planned U.S. trial, under discussion with the FDA, is expected to assess the longer term efficacy and safety of pamrevlumab in patients who recovered or are recovering from COVID-19 infection with evidence of interstitial lung disease.    

    "Given our expertise in CTGF biology and its potential application in lung disease, we have a unique approach to the treatment of patients suffering from severe pulmonary involvement of COVID-19. The Italy and U.S. trials will determine if pamrevlumab treatment of hospitalized COVID-19 patients improves patient outcomes, both during the acute phase of infection and longer term with improved outcomes in interstitial lung disease," said Enrique Conterno, Chief Executive Officer, FibroGen. "In these devastating times, we are grateful for the collaboration of health authorities, health care providers, and patients in enabling the conduct of these trials."

    About Pamrevlumab

    Pamrevlumab is a first-in-class antibody developed by FibroGen that inhibits the activity of connective tissue growth factor (CTGF), a common factor in fibrotic and proliferative disorders. Pamrevlumab is in Phase 3 clinical development for the treatment of idiopathic pulmonary fibrosis (IPF) and locally advanced unresectable pancreatic cancer (LAPC), and in Phase 2 clinical development for the treatment of Duchenne muscular dystrophy (DMD) and coronavirus (COVID-19). For information about pamrevlumab studies currently recruiting patients, please visit www.clinicaltrials.gov.

    About FibroGen

    FibroGen, Inc. is a biopharmaceutical company committed to discovering, developing and commercializing a pipeline of first-in-class therapeutics. The company applies its pioneering expertise in hypoxia-inducible factor (HIF) and connective tissue growth factor (CTGF) biology to advance innovative medicines to treat unmet needs. The Company is currently developing and commercializing roxadustat, an oral small molecule inhibitor of HIF prolyl hydroxylase activity, for anemia associated with chronic kidney disease (CKD). Roxadustat is also in clinical development for anemia associated with myelodysplastic syndromes (MDS) and for chemotherapy-induced anemia. Pamrevlumab, an anti-CTGF human monoclonal antibody, is in clinical development for the treatment of idiopathic pulmonary fibrosis (IPF), locally advanced unresectable pancreatic cancer, Duchenne muscular dystrophy (DMD), and coronavirus (COVID-19). For more information, please visit www.fibrogen.com.

    Forward-Looking Statements

    This release contains forward-looking statements regarding our strategy, future plans and prospects, including statements regarding the development and commercialization of the company's product candidates, the potential safety and efficacy profile of our product candidates, our clinical programs and regulatory events, and those of our partners. These forward-looking statements include, but are not limited to, statements about our plans, objectives, representations and contentions and are not historical facts and typically are identified by use of terms such as "may," "will", "should," "on track," "could," "expect," "plan," "anticipate," "believe," "estimate," "predict," "potential," "continue" and similar words, although some forward-looking statements are expressed differently. Our actual results may differ materially from those indicated in these forward-looking statements due to risks and uncertainties related to the continued progress and timing of our various programs, including the enrollment and results from ongoing and potential future clinical trials, and other matters that are described in our Annual Report on Form 10-K for the fiscal year ended December 31, 2019 and our Quarterly Report on Form 10-Q for quarter ended March 31, 2020 filed with the Securities and Exchange Commission (SEC), including the risk factors set forth therein. Investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this release, and we undertake no obligation to update any forward-looking statement in this press release, except as required by law.

    Contact:

    FibroGen, Inc.

    Media Inquiries:

    Sara Iacovino

    1.703.474.4452



    Investors:

    Michael Tung, M.D.

    Corporate Strategy / Investor Relations

    1.415.978.1434



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  4. TOKYO and SAN FRANCISCO, May 21, 2020 (GLOBE NEWSWIRE) -- Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., "Astellas") and FibroGen, Inc. (NASDAQ:FGEN, CEO: Enrique Conterno, "FibroGen")) today announced the marketing authorization application (MAA) for roxadustat for the treatment of anemia in adult patients with chronic kidney disease (CKD) has been accepted by the European Medicines Agency (EMA) for regulatory review.

    The MAA is supported by positive results from a pivotal Phase 3 program, which involved more than 9,000 patients worldwide.1-7 The MAA dossier includes the DOLOMITES study, the results of which will be disclosed later this year.8,9 Results from these studies support roxadustat as efficacious in increasing…

    TOKYO and SAN FRANCISCO, May 21, 2020 (GLOBE NEWSWIRE) -- Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., "Astellas") and FibroGen, Inc. (NASDAQ:FGEN, CEO: Enrique Conterno, "FibroGen")) today announced the marketing authorization application (MAA) for roxadustat for the treatment of anemia in adult patients with chronic kidney disease (CKD) has been accepted by the European Medicines Agency (EMA) for regulatory review.

    The MAA is supported by positive results from a pivotal Phase 3 program, which involved more than 9,000 patients worldwide.1-7 The MAA dossier includes the DOLOMITES study, the results of which will be disclosed later this year.8,9 Results from these studies support roxadustat as efficacious in increasing and maintaining target hemoglobin levels with reduced use of intravenous iron in adult patients with CKD anemia, both those who are dialysis dependent (DD) and those non-dialysis dependent (NDD). These data also support a favorable risk:benefit profile with cardiovascular (CV) and general safety of roxadustat reflective of the underlying conditions of the CKD population.1-6

    "This acceptance marks a significant milestone for roxadustat, which we believe has the potential to offer an important new oral therapeutic option in the EU for the management of anemia in adults with chronic kidney disease," said Bernhardt G. Zeiher, M.D., Chief Medical Officer, Astellas. "Chronic kidney disease impacts one in eight people in Europe, of whom one in five are affected by anemia that is often untreated or not treated to target. We look forward to the review and assessment by EMA in the hope of bringing this innovative treatment to patients across the EU."

    "There is significant unmet medical need for patients with anemia of CKD, a serious and often life-threatening disease," said K. Peony Yu, M.D., Chief Medical Officer, FibroGen. "This submission and FibroGen's recent submission of a New Drug Application in the U.S. are supported by positive results from the largest global phase 3 program in patients with CKD anemia. We look forward to working with Astellas during the EMA's review of the MAA, and to the potential of roxadustat as a new therapeutic option for treating anemia in CKD patients on dialysis and not on dialysis across Europe."

    EMA's acceptance of the roxadustat MAA for treatment of anemia in adult patients with CKD on dialysis and not on dialysis triggers a milestone payment of $130 million by Astellas to FibroGen.

    About Clinical Trials
    For more information about the clinical trials associated with the accepted MAA (1517-CL-0613 (PYRENEES),1 1517-CL-0608 (ALPS),2 FGCL-4592-060 (ANDES),3 FGCL-4592-063 (HIMALAYAS),4 FGCL-4592-064 (SIERRAS),5 D5740C00001 (OLYMPUS),6 D5740C00002 (ROCKIES),7 1517-CL-0610 (DOLOMITES)8,9), please visit www.clinicaltrials.gov or clinicaltrialsregister.eu.

    About CKD and Anemia
    CKD is a progressive loss of kidney function caused by damage to the kidneys resulting from conditions such as hypertension, diabetes or immune-regulated inflammatory conditions.10 Worldwide 1 in 10 people are living with CKD.11 In Europe 1 in 8 people are living with CKD,11 of whom 1 in 5 are affected by anemia, this rises to 1 in 2 in people with the most severe CKD (CKD stage 5).12 CKD is predicted to become the fifth most common cause of premature death globally by 2040.13 It is a critical worldwide healthcare issue that represents a large and growing unmet medical need.

    Anemia is a common complication of CKD,14 resulting from the failing kidneys' diminished ability to produce erythropoietin, which stimulates red blood cell production in the bone marrow. It is associated with significant morbidity and mortality in dialysis and non-dialysis populations, increasing in both prevalence and severity as kidney disease worsens.15,16 Anemia associated with CKD increases the risk of adverse cardiovascular events, worsens renal outcomes and can negatively impact patients' quality of life.16–18

    About Roxadustat
    Roxadustat is a first-in-class orally administered inhibitor of hypoxia-inducible factor (HIF) prolyl­ hydroxylase (PH), which increases hemoglobin levels with a mechanism of action that is different from that of erythropoiesis-stimulating agents. As a HIF-PH inhibitor, roxadustat activates a response that occurs naturally when the body responds to reduced oxygen levels in the blood. This response involves the regulation of multiple, complementary processes to promote erythropoiesis and to increase the blood's oxygen-carrying capacity.

    Roxadustat is approved and launched for the treatment of anemia associated with CKD in Japan in DD patients and in China in both DD and NDD patients. A supplemental New Drug Application (sNDA) has been submitted to Japan's Pharmaceuticals and Medical Devices Agency for NDD patients and a New Drug Application (NDA) has been submitted in the US in both DD and NDD patients.

    Astellas and FibroGen are collaborating on the development and commercialization of roxadustat for the potential treatment of anemia in territories including Japan, Europe, the Commonwealth of Independent States, the Middle East and South Africa. FibroGen and AstraZeneca are collaborating on the development and commercialization of roxadustat for the potential treatment of anemia in the US, China and other markets in the Americas and in Australia/New Zealand as well as Southeast Asia.

    About Astellas
    Astellas Pharma Inc., based in Tokyo, Japan, is a company dedicated to improving the health of people around the world through the provision of innovative and reliable pharmaceutical products. For more information, please visit https://www.astellas.com/en.

    About FibroGen
    FibroGen, Inc., headquartered in San Francisco, with subsidiary offices in Beijing and Shanghai, is a leading biopharmaceutical company discovering, developing, and commercializing a pipeline of first-in-class therapeutics. The company applies its pioneering expertise in hypoxia-inducible factor, connective tissue growth factor biology and clinical development to advance innovative medicines for the treatment of anemia, fibrotic disease and cancer. For more information, please visit www.fibrogen.com.

    Astellas Cautionary Notes
    In this press release, statements made with respect to current plans, estimates, strategies and beliefs, and other statements that are not historical facts are forward-looking statements about the future performance of Astellas. These statements are based on management's current assumptions and beliefs in light of the information currently available to it and involve known and unknown risks and uncertainties. A number of factors could cause actual results to differ materially from those discussed in the forward-looking statements. Such factors include, but are not limited to: (i) changes in general economic conditions and in laws and regulations, relating to pharmaceutical markets, (ii) currency exchange rate fluctuations, (iii) delays in new product launches, (iv) the inability of Astellas to market existing and new products effectively, (v) the inability of Astellas to continue to effectively research and develop products accepted by customers in highly competitive markets and (vi) infringements of Astellas' intellectual property rights by third parties.

    Information about pharmaceutical products (including products currently in development) that is included in this press release is not intended to constitute an advertisement or medical advice.

    FibroGen Forward-Looking Statements
    This release contains forward-looking statements regarding FibroGen's strategy, future plans and prospects, including statements regarding the development of the company's product candidates, the potential safety and efficacy profile of our product candidates, our clinical and regulatory plans and those of our partners. These forward-looking statements include, but are not limited to, statements about our plans, objectives, representations and contentions and are not historical facts and typically are identified by use of terms such as "may", "will", "should", "on track", "could", "expect", "plan", "anticipate", "believe", "estimate", "predict", "potential", "continue" and similar words, although some forward-looking statements are expressed differently. Our actual results may differ materially from those indicated in these forward-looking statements due to risks and uncertainties related to the continued progress and timing of our various programs, including the enrollment and results from ongoing and potential future clinical trials, and other matters that are described in our Annual Report on Form 10-K for the fiscal year that ended December 31, 2019 and our quarterly report on 10-Q for the fiscal quarter that ended March 31, 2020 filed with the Securities and Exchange Commission, including the risk factors set forth therein. Investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this release, and we undertake no obligation to update any forward-looking statement in this press release, except as required by law.

    Contacts for inquiries or additional information:
    Astellas Portfolio Communications
    Anna Otten
    TEL: +1 (224) 205-6651 | Email:

    FibroGen, Inc.
    Media Inquiries:
    Sara Iacovino
    TEL: 1.703.474.4452 | Email:  
    Investors:
    Michael Tung, M.D.
    Corporate Strategy / Investor Relations
    TEL: 1.415.978.1434 | Email:

    REFERENCES

    1 Clinicaltrials.gov. Roxadustat in the Treatment of Anemia in End Stage Renal Disease (ESRD) Patients on Stable Dialysis (Pyrenees) Available from: https://clinicaltrials.gov/ct2/show/NCT02278341 [Last accessed: April 2020].

    2 Clinicaltrials.gov. Roxadustat in the Treatment of Anemia in Chronic Kidney Disease Patients Not Requiring Dialysis (ALPS). Available from: https://clinicaltrials.gov/ct2/show/NCT01887600 [Last accessed: April 2020].

    3 Clinicaltrials.gov. A Study of FG-4592 for the Treatment of Anemia in Chronic Kidney Disease Patients Not Receiving Dialysis. Available from: https://clinicaltrials.gov/ct2/show/NCT01750190 [Last accessed: April 2020].

    4 Clinicaltrials.gov. Safety and Efficacy Study for Treatment of Anemia in ESRD Newly Initiated Dialysis Patients (Himalayas). Available from: https://clinicaltrials.gov/ct2/show/NCT02052310 [Last accessed: April 2020].

    5 Clinicaltrials.gov. Evaluation of Efficacy and Safety of Roxadustat in the Treatment of Anemia in Stable Dialysis Subjects. Available from: https://clinicaltrials.gov/ct2/show/NCT02273726 [Last accessed: April 2020].

    6 Clinicaltrials.gov. Safety and Efficacy Study of Roxadustat to Treat Anemia in Patients With Chronic Kidney Disease (CKD), Not on Dialysis. Available from: https://clinicaltrials.gov/ct2/show/NCT02174627 [Last accessed: April 2020].

    7 Clinicaltrials.gov. Safety and Efficacy Study of Roxadustat to Treat Anemia in Patients With Chronic Kidney Disease, on Dialysis. Available from: https://clinicaltrials.gov/ct2/show/NCT02174731 [Last accessed: April 2020].

    8 Clinicaltrials.gov. Roxadustat in the Treatment of Anemia in Chronic Kidney Disease (CKD) Patients, Not on Dialysis, in Comparison to Darbepoetin Alfa (Dolomites). Available from: https://clinicaltrials.gov/ct2/show/NCT02021318 [Last accessed: April 2020].

    9 Clinicaltrialsregister.eu. A Phase 3, Randomized, Open-Label, Active-Controlled Study to Evaluate the Efficacy and Safety of Roxadustat in the Treatment of Anaemia in Chronic Kidney Disease Patients Not on Dialysis. Available from: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2013-000951-42 [Last accessed: April 2020]

    10 Ojo A. Addressing the Global Burden of Chronic Kidney Disease Through Clinical and Translational Research. Trans Am Clin Climatol Assoc 2014;125:229–246.

    11 International Society of Nephrology. Chronic kidney disease. Global kidney health atlas. Available from: www.theisn.org/global-atlas [Last accessed: April 2020].

    12 Dmitrieva O, de Lusignan S, Macdougall IC, et al. Association of anaemia in primary care patients with chronic kidney disease: cross sectional study of quality improvement in chronic kidney disease (QICKD) trial data. BMC Nephrol 2013;14:24.

    13 Institute for Health Metrics and Evaluation (IHME). Findings from the Global Burden of Disease Study 2017. Seattle, WA: IHME, 2018. Available from: http://www.healthdata.org/sites/default/files/files/policy_report/2019/GBD_2017_Booklet.pdf [Last accessed: April 2020].

    14 McClellan W, Aronoff SL, Bolton WK, et al. The prevalence of anemia in patients with chronic kidney disease. Curr Med Res Opin 2004;20:1501–1510.

    15 Stauffer M and Fan T. Prevalence of Anemia in Chronic Kidney Disease in the United States. PLoS One 2014;9:e84943.

    16 Mohanram A, Zhang Z, Shahinfar S, et al. Anemia and end-stage renal disease in patients with type 2 diabetes and nephropathy. Kidney Int 2004;66:1131–1138.

    17 Weiner DE, Tighiouart H, Stark PC, et al. Kidney disease as a risk factor for recurrent cardiovascular disease and mortality. Am J Kidney Dis 2004;44:198–206.

    18 Eriksson D, Goldsmith D, Teitsson S, et al. Cross-sectional survey in CKD patients across Europe describing the association between quality of life and anaemia. BMC Nephrol 2016;17:97.

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