FGEN FibroGen Inc

10.14
-1.1  -10%
Previous Close 11.24
Open 10.82
52 Week Low 11.08
52 Week High 57.2088
Market Cap $939,186,482
Shares 92,621,941
Float 81,614,674
Enterprise Value $641,580,275
Volume 2,050,138
Av. Daily Volume 1,766,607
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Upcoming Catalysts

Drug Stage Catalyst Date
Roxadustat (WHITNEY)
Chemotherapy-induced anemia (CIA)
Phase 2
Phase 2
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Pamrevlumab (LAPIS)
Pancreatic cancer
Phase 3
Phase 3
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Pamrevlumab - LELANTOS
Duchenne muscular dystrophy
Phase 3
Phase 3
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Roxadustat (MATTERHORN)
Myelodysplastic syndromes (MDS)
Phase 3
Phase 3
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Pamrevlumab - (ZEPHYRUS-1)
Idiopathic pulmonary fibrosis
Phase 3
Phase 3
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Drug Pipeline

Drug Stage Notes
Roxadustat
Anaemia in Chronic Kidney Disease
CRL
CRL
CRL announced August 11, 2021.
Pamrevlumab - LELANTOS-2
Duchenne Muscular Dystrophy
Phase 3
Phase 3
Phase 3 second trial initiation announced March 16, 2021.

Latest News

  1. SAN FRANCISCO, Aug. 25, 2021 (GLOBE NEWSWIRE) -- FibroGen, Inc. (NASDAQ: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 (HIF-PHI), for the treatment of chemotherapy-induced anemia (CIA).

    WHITNEY is a Phase 2, open label study investigating the efficacy and safety of roxadustat for treatment of anemia in patients receiving concurrent chemotherapy treatment for non-myeloid malignancies. The primary efficacy endpoint of maximum change in hemoglobin within 16 weeks from baseline without red blood cell transfusion was met.

    "Roxadustat is a promising new approach for treating chemotherapy induced…

    SAN FRANCISCO, Aug. 25, 2021 (GLOBE NEWSWIRE) -- FibroGen, Inc. (NASDAQ: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 (HIF-PHI), for the treatment of chemotherapy-induced anemia (CIA).

    WHITNEY is a Phase 2, open label study investigating the efficacy and safety of roxadustat for treatment of anemia in patients receiving concurrent chemotherapy treatment for non-myeloid malignancies. The primary efficacy endpoint of maximum change in hemoglobin within 16 weeks from baseline without red blood cell transfusion was met.

    "Roxadustat is a promising new approach for treating chemotherapy induced anemia, which complicates the treatment of many cancer patients," said Mark D. Eisner, MD, MPH, Chief Medical Officer, FibroGen. "Further studies will be necessary to evaluate whether roxadustat can effectively and safely treat this important type of anemia."

    In WHITNEY, ninety-two patients with non-myeloid malignancy (solid tumor) having a hemoglobin level at or below 10 g/dL were enrolled. Patients received a starting roxadustat dose of 2.0 mg/kg or 2.5 mg/kg, three times per week (TIW), during a treatment period of 16 weeks, with an additional 4-week follow-up period. Doses could be titrated every 4 weeks.

    Roxadustat was generally well tolerated and there were no substantive differences in treatment-emergent adverse events (TEAEs) between arms with different starting doses.

    The full results of the study will be presented at a medical meeting later this year.

    For more information regarding this study, please visit www.clinicaltrials.gov (NCT04076943).

    About Chemotherapy-Induced Anemia

    Although chemotherapy-induced anemia is one of the most common side effects of chemotherapy, it is often not recognized and is frequently undertreated. CIA can adversely affect long-term patient outcomes, as the anemia limits both quality of life and efficacy of chemotherapy treatment. The incidence and severity of CIA depends on a variety of factors. This includes the type of cancer and the treatment, including the type of chemotherapy, schedule, and intensity of therapy. It also depends on whether the patient has received prior myelosuppressive chemotherapy, radiation therapy, or both. An estimated 30% to 90% of cancer patients receiving chemotherapy develop anemia1. Approximately 650,000 cancer patients undergo chemotherapy every year in the United States2.

    About Roxadustat

    Roxadustat, an oral medication, is the first in a new class of medicines comprising HIF-PH inhibitors that promote erythropoiesis, or red blood cell production, through increased endogenous production of erythropoietin, improved iron absorption and mobilization, and downregulation of hepcidin. Roxadustat is also in clinical development for anemia of chronic kidney disease (CKD) and anemia associated with myelodysplastic syndromes (MDS).

    Roxadustat is approved in European Union (EU) member states, including the European Economic Area (EEA) countries, as well as in Japan, China, Chile and South Korea for the treatment of anemia of CKD in adult patients on dialysis (DD) and not on dialysis (NDD). Several other licensing applications for roxadustat have been submitted by partners, Astellas and AstraZeneca to regulatory authorities across the globe, and are currently under review.

    Astellas and FibroGen are collaborating on the development and commercialization of roxadustat for the potential treatment of anemia in territories including Japan, Europe, Turkey, Russia and 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 U.S., China, other markets in the Americas, in Australia/New Zealand, and Southeast Asia.

    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 for the treatment of unmet needs. The Company is currently developing and commercializing roxadustat, an oral small molecule inhibitor of HIF prolyl hydroxylase activity, for anemia associated with myelodysplastic syndromes (MDS) and for chemotherapy-induced anemia (CIA). Pamrevlumab, an anti-CTGF human monoclonal antibody, is in clinical development for the treatment of locally advanced unresectable pancreatic cancer (LAPC), Duchenne muscular dystrophy (DMD), and idiopathic pulmonary fibrosis (IPF). 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. These include, 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, 2020 and our Quarterly Report on Form 10-Q for quarter ended June 30, 2021 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.

    References:

    1. https://www.cdc.gov/cancer/preventinfections/providers.htm
    2. National Cancer Institute estimates of annual diagnoses from 2007 to 2011

    Contacts:

    FibroGen, Inc.

    Investors:

    Michael Tung, M.D.

    Corporate Strategy / Investor Relations

    415.978.1434

    mtung@fibrogen.com

    Media:

    GCI Health

    FibroGenMedia@gcihealth.com 



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  2. TOKYO, Aug. 19, 2021 /PRNewswire/ -- Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., "Astellas") and FibroGen, Inc. (NASDAQ:FGEN, CEO: Enrique Conterno, ", FibroGen", ))) today announced that the European Commission (EC) has approved EVRENZO (roxadustat) for the treatment of adult patients with symptomatic anemia associated with chronic kidney disease (CKD).

    "We are very pleased EVRENZO has been approved as the first oral HIF-PH inhibitor to treat adult patients with symptomatic anemia associated with CKD in the European Union," said Steven Benner, M.D., M.H.S., President of Development, Astellas. "Today's approval provides patients, regardless of dialysis status, with a first-in-class treatment option to address…

    TOKYO, Aug. 19, 2021 /PRNewswire/ -- Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., "Astellas") and FibroGen, Inc. (NASDAQ:FGEN, CEO: Enrique Conterno, ", FibroGen", ))) today announced that the European Commission (EC) has approved EVRENZO (roxadustat) for the treatment of adult patients with symptomatic anemia associated with chronic kidney disease (CKD).

    "We are very pleased EVRENZO has been approved as the first oral HIF-PH inhibitor to treat adult patients with symptomatic anemia associated with CKD in the European Union," said Steven Benner, M.D., M.H.S., President of Development, Astellas. "Today's approval provides patients, regardless of dialysis status, with a first-in-class treatment option to address the multifaceted nature of this condition. We look forward to making roxadustat available to adult patients with anemia of CKD in countries across the European Union."

    CKD impacts one in 10 people globally, of whom one in five are affected by anemia.1, 2 Anemia of CKD is often untreated or not treated to target, and is associated with reduced quality of life and progression to adverse cardiovascular (CV) and renal outcomes.3-5 

    "Anemia is a significant and early complication of CKD that occurs with greater frequency and impact as CKD worsens, affecting patients' day-to-day living, self-care and mobility," said Jonathan Barratt, Ph.D., FRCP, Consultant Nephrologist and the Mayer Professor of Renal Medicine at the University of Leicester, United Kingdom. "This approval represents a step forward in providing patients with an efficient and simple option to manage anemia symptoms and maintain target hemoglobin levels to minimize the impact on their quality of life."

    Roxadustat is the first orally administered HIF-PH inhibitor available in the European Union. Roxadustat increases hemoglobin (Hb) levels through a different mechanism of action compared to injectable erythropoiesis-stimulating agents (ESAs) which are typically co-administered with intravenous iron. As a HIF-PH inhibitor, roxadustat activates the body's natural response to reduced oxygen levels in the blood. This response involves the regulation of multiple, coordinated processes that allow management of anemia with a reduced use of intravenous iron.

    "HIF-PH inhibitors represent a major advance in the treatment of anemia of CKD," said Mark Eisner, M.D., M.P.H., Chief Medical Officer, FibroGen. "Roxadustat provides a novel breakthrough for patients who suffer from this condition."

    This approval follows the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) positive opinion to authorize roxadustat in June6 based on results from a comprehensive pivotal Phase 3 program comprising of eight multicenter and randomized studies, which involved 9,600 patients worldwide.7-12 The results of this program showed roxadustat was efficacious in achieving and maintaining target Hb levels (10-12g/dL) in patients with symptomatic anemia of CKD regardless of dialysis status and irrespective of prior ESA treatment.7-11 The safety profile observed in the roxadustat development program is reflective of the CKD populations studied and comparable to ESAs.7-12

    The EC has the authority to approve medicines for European Union member states, as well as in the European Economic Area (EEA) countries Iceland, Norway, Liechtenstein.13

    The EC approval of roxadustat triggers a milestone payment of $120 million by Astellas to FibroGen, and FibroGen will also receive royalties based upon European net sales.

    About CKD and Anemia of CKD

    Chronic kidney disease (CKD) is 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.14 Many patients with CKD die of cardiovascular complications before progressing to kidney failure and as such the prevalence of early kidney disease is much greater than end-stage disease.14, 15 CKD impacts one in 10 people globally and is predicted to become the fifth most common cause of premature death globally by 2040.1, 16 

    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 affecting approximately 20% of CKD patients.2, 17 Anemia of 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.4, 18 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.19, 20

    About Roxadustat

    Roxadustat, an oral medicine, is the first in a new class of medicines, HIF-PH inhibitors, that promote erythropoiesis, or red blood cell production, through increased endogenous production of erythropoietin; improved iron absorption and mobilization; and downregulation of hepcidin. Roxadustat is also in Phase 3 clinical development for anemia associated with myelodysplastic syndromes (MDS) and Phase 2 for chemotherapy-induced anemia (CIA).

    Roxadustat is approved in EU member states, including the EEA countries, as well as in Japan, China, Chile and South Korea for the treatment of anemia of CKD in adult patients on dialysis (DD) and not on dialysis (NDD). Several other licensing applications for roxadustat have been submitted by Astellas and AstraZeneca to regulatory authorities across the globe and are currently in review.

    Astellas and FibroGen are collaborating on the development and commercialization of roxadustat for the potential treatment of anemia of CKD in territories including Japan, Europe, Turkey, Russia and 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 of CKD in the U.S., China, other markets in the Americas, in Australia/New Zealand, and Southeast Asia.

    Important Safety Information

    The full European Summary of Product Characteristics (SPC/SmPC) for roxadustat will be available from the European Medicines Agency at www.ema.europa.eu 21

    About Astellas

    Astellas Pharma Inc., is a pharmaceutical company conducting business in more than 70 countries around the world. We are promoting the Focus Area Approach that is designed to identify opportunities for the continuous creation of new drugs to address diseases with high unmet medical needs by focusing on Biology and Modality. Furthermore, we are also looking beyond our foundational Rx focus to create Rx+® healthcare solutions that combine our expertise and knowledge with cutting-edge technology in different fields of external partners. Through these efforts, Astellas stands on the forefront of healthcare change to turn innovative science into value for patients. For more information, please visit our website at https://www.astellas.com/en.

    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 for the treatment of 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 (CIA). Pamrevlumab, an anti-CTGF human monoclonal antibody, is in clinical development for the treatment of locally advanced unresectable pancreatic cancer (LAPC), Duchenne muscular dystrophy (DMD), and idiopathic pulmonary fibrosis (IPF). 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 our strategy, future plans and prospects, including statements regarding the development and commercialization of the Company's product candidates, the prevalence of CKD and anemia, the potential safety and efficacy profile of our product candidates, our clinical and regulatory events. 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 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, 2020 and our Quarterly Report on Form 10-Q for the quarter ended June 30, 2021 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.

    References

    1. Nephrology ISo. Chronic kidney disease. Global kidney health atlas 2019 [Accessed August 2021]. Available from: https://www.theisn.org/wp-content/uploads/2021/05/GKHAtlas_2019_WebFIle-1.pdf.

    2. Dmitrieva O, de Lusignan S, Macdougall IC, Gallagher H, Tomson C, Harris K, 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.

    3. Wong MMY, Tu C, Li Y, Perlman RL, Pecoits-Filho R, Lopes AA, et al. Anemia and iron deficiency among chronic kidney disease Stages 3-5ND patients in the Chronic Kidney Disease Outcomes and Practice Patterns Study: often unmeasured, variably treated. Clin Kidney J. 2020;13(4):613-24.

    4. Schmidt RJ, Dalton CL. Treating anemia of chronic kidney disease in the primary care setting: cardiovascular outcomes and management recommendations. Osteopath Med Prim Care. 2007;1:14.

    5. Stauffer ME, Fan T. Prevalence of anemia in chronic kidney disease in the United States. PLoS One. 2014;9(1):e84943.

    6. European Medicines Agency. Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) June 2021  [Accessed August 2021]. Available from: https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-21-24-june-2021.

    7. Clinicaltrials.Gov. Roxadustat in the Treatment of Anemia in End Stage Renal Disease (ESRD) Patients on Stable Dialysis (Pyrenees). NCT02278341.  [Accessed August 2021]. Available from: https://clinicaltrials.gov/ct2/show/NCT02278341.

    8. Shutov E, Sułowicz W, Esposito C, Tataradze A, Andric B, Reusch M, et al. Roxadustat for the treatment of anemia in chronic kidney disease patients not on dialysis: a phase 3, randomized, double-blind, placebo-controlled study (ALPS). Nephrol Dial Transplant. 2021; 1-11. doi: 10.1093/ndt/gfab057.

    9. Coyne DW, Roger SD, Shin SK, Kim SG, Cadena AA, Moustafa MA, et al. Roxadustat for CKD-related Anemia in Non-dialysis Patients. Kidney Int Rep. 2021;6(3):624-35.

    10. Provenzano R, Shutov E, Eremeeva L, Korneyeva S, Poole L, Saha G, et al. Roxadustat for anemia in patients with end-stage renal disease incident to dialysis. Nephrol Dial Transplant. 2021. doi: 10.1093/ndt/gfab051.

    11. Fishbane S, El-Shahawy MA, Pecoits-Filho R, Van BP, Houser MT, Frison L, et al. Roxadustat for Treating Anemia in Patients with CKD Not on Dialysis: Results from a Randomized Phase 3 Study. J Am Soc Nephrol. 2021;32(3):737-55.

    12. Barratt J, Andric B, Tataradze A, Schömig M, Reusch M, Valluri U, et al. Roxadustat for the treatment of anaemia in chronic kidney disease patients not on dialysis: a phase 3, randomised, open-label, active-controlled study (DOLOMITES). Nephrol Dial Transplant. 2021. 1-13. doi: 10.1093/ndt/gfab191.

    13. European Medicines Agency. Authorizations of Medicines  [Accessed August 2021]. Available from: https://www.ema.europa.eu/about-us/what-we-do/authorisation-medicines

    14. Ojo A. Addressing the global burden of chronic kidney disease through clinical and translational research. Trans Am Clin Climatol Assoc. 2014;125:229-43; discussion 43-6.

    15. Subbiah AK, Chhabra YK, Mahajan S. Cardiovascular disease in patients with chronic kidney disease: a neglected subgroup. Heart Asia. 2016;8(2):56-61.

    16. Institute for Health Metrics and Evaluation (IHME). Findings from the Global Burden of Disease Study 2017 2018 [Accessed August 2021]. Available from: http://www.healthdata.org/sites/default/files/files/policy_report/2019/GBD_2017_Booklet.pdf.

    17. National Kidney Foundation. Anemia and Chronic Kidney Disease  [Accessed August 2021]. Available from: https://www.kidney.org/atoz/content/what_anemia_ckd.

    18. Eriksson D, Goldsmith D, Teitsson S, Jackson J, van Nooten F. Cross-sectional survey in CKD patients across Europe describing the association between quality of life and anaemia. BMC Nephrol. 2016;17(1):97.

    19. Disease NIoDaDaK. Anemia in Chronic Kidney Disease: National Institute of Diabetes and Digestive and Kidney Disease;  [Accessed August 2021]. Available from: https://www.niddk.nih.gov/health-information/kidney-disease/anemia.

    20. Sahu S, Hemlata, Verma A. Adverse events related to blood transfusion. Indian J Anaesth. 2014;58(5):543-51.

    21. Data on file. Northbrook, III. Astellas Pharma Inc.

    Cision View original content:https://www.prnewswire.com/news-releases/astellas-receives-european-commission-approval-for-first-in-class-evrenzo-roxadustat-for-adult-patients-with-symptomatic-anemia-of-chronic-kidney-disease-301359297.html

    SOURCE Astellas Pharma Inc.

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  3. SAN FRANCISCO, Aug. 16, 2021 (GLOBE NEWSWIRE) -- FibroGen, Inc. (NASDAQ:FGEN) announced the retirement of Pat Cotroneo, Chief Financial Officer, and the appointment of Juan Graham in that role. Pat will continue as Chief Financial Officer through September 6, 2021, and will remain with FibroGen through March 31, 2022 serving as Executive Advisor to the CEO to ensure a smooth transition.

    "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. "With his leadership, FibroGen transitioned from a private to public company, and from a development stage to commercial stage…

    SAN FRANCISCO, Aug. 16, 2021 (GLOBE NEWSWIRE) -- FibroGen, Inc. (NASDAQ:FGEN) announced the retirement of Pat Cotroneo, Chief Financial Officer, and the appointment of Juan Graham in that role. Pat will continue as Chief Financial Officer through September 6, 2021, and will remain with FibroGen through March 31, 2022 serving as Executive Advisor to the CEO to ensure a smooth transition.

    "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. "With his leadership, FibroGen transitioned from a private to public company, and from a development stage to commercial stage company."

    Juan Graham will become Chief Financial Officer effective September 7, 2021, overseeing all finance operations. Mr. Graham has nearly two decades of global biopharmaceutical financial management and strategic planning experience.

    "Juan's extensive financial leadership and strategic planning come at a critical time for FibroGen as we look ahead to multiple significant clinical milestones," said Mr. Conterno. "The depth and breadth of his financial experience is an ideal fit, and we are thrilled to welcome him to the FibroGen team."

    "I am excited about joining FibroGen and helping deliver the Company's vision in the advancement of breakthrough science and novel medicines in areas of high unmet clinical need for patients around the world," said Mr. Graham.

    Mr. Graham was most recently Global Chief Financial Officer / Vice President Finance Supply Chain at Johnson & Johnson, Inc. Juan spent the last 20 years at Johnson & Johnson, Inc. in a variety of roles including VP Finance & Business Development, Senior Finance Director, J&J Development Corporation / J&J Innovation, and Finance Director, Mergers & Acquisitions to name a few. Juan received his bachelor's degree in Business Administration from the Monterrey Institute of Technology and Higher Education. He received his Master's in Business Administration from the McGill University Graduate School of Business.

    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 for the treatment of 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 (CIA). Pamrevlumab, an anti-CTGF human monoclonal antibody, is in clinical development for the treatment of locally advanced unresectable pancreatic cancer (LAPC), Duchenne muscular dystrophy (DMD), and idiopathic pulmonary fibrosis (IPF). 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, 2020 and our Quarterly Report on Form 10-Q for quarter ended June 30, 2021 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.

    Investors:

    Michael Tung, M.D.

    Corporate Strategy / Investor Relations

    415.978.1434

    mtung@fibrogen.com

    Media:

    GCI Health

    FibroGenMedia@gcihealth.com



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  4. SAN FRANCISCO, Aug. 11, 2021 (GLOBE NEWSWIRE) -- FibroGen, Inc. (NASDAQ:FGEN) today announced that the U.S. Food and Drug Administration (FDA) has issued a complete response letter regarding the New Drug Application (NDA) for roxadustat for the treatment of anemia of chronic kidney disease (CKD).

    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.  

    "We are deeply disappointed with this result, and this is an unfortunate day for patients suffering from anemia of CKD in the United States," said Enrique Conterno, Chief Executive Officer, FibroGen. "Roxadustat is changing the lives of patients around the world, and…

    SAN FRANCISCO, Aug. 11, 2021 (GLOBE NEWSWIRE) -- FibroGen, Inc. (NASDAQ:FGEN) today announced that the U.S. Food and Drug Administration (FDA) has issued a complete response letter regarding the New Drug Application (NDA) for roxadustat for the treatment of anemia of chronic kidney disease (CKD).

    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.  

    "We are deeply disappointed with this result, and this is an unfortunate day for patients suffering from anemia of CKD in the United States," said Enrique Conterno, Chief Executive Officer, FibroGen. "Roxadustat is changing the lives of patients around the world, and we and our partner AstraZeneca will discuss next steps in the U.S."

    Roxadustat is approved in China, Japan, Chile, and South Korea for the treatment of anemia of CKD in both non-dialysis-dependent (NDD) and dialysis-dependent (DD) adult patients and has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP), the European Medicines Agency's committee responsible for human medicines. The European Commission decision is expected by the end of August.

    About Anemia of 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 percent of adults worldwide and is predicted to become the fifth most common cause of premature death globally by 2040.

    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, affecting approximately 20 percent of CKD patients. Anemia of 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, an oral medicine, is the first in a new class of medicines, HIF-PH inhibitors that promote erythropoiesis, or red blood cell production, through increased endogenous production of erythropoietin; improved iron absorption and mobilization; and downregulation of hepcidin. Roxadustat is also in clinical development for anemia associated with myelodysplastic syndromes (MDS) and for chemotherapy-induced anemia (CIA).

    Roxadustat is approved in China, Japan, Chile, and South Korea for the treatment of anemia of CKD in adult patients on dialysis (DD) and not on dialysis (NDD). In Europe, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) 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 (CKD). Several other licensing applications for roxadustat have been submitted by Astellas and AstraZeneca to regulatory authorities across the globe, and are currently in review.

    Astellas and FibroGen are collaborating on the development and commercialization of roxadustat for the potential treatment of anemia of CKD in territories including Japan, Europe, Turkey, Russia, and 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 of CKD in the U.S., China, other markets in the Americas, in Australia/New Zealand, and Southeast Asia.

    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 for the treatment of unmet needs. The Company is currently developing and commercializing roxadustat, an oral small molecule inhibitor of HIF prolyl hydroxylase activity, for anemia of chronic kidney disease (CKD). Roxadustat is also in clinical development for anemia associated with myelodysplastic syndromes (MDS) and for chemotherapy-induced anemia (CIA). Pamrevlumab, an anti-CTGF human monoclonal antibody, is in clinical development for the treatment of locally advanced unresectable pancreatic cancer (LAPC), Duchenne muscular dystrophy (DMD), and idiopathic pulmonary fibrosis (IPF). 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 and product, the potential safety and efficacy profile of our product candidates and product, our clinical programs and regulatory events, and those of our partners, and the commercial and clinical success of HIFRENZO (roxadustat) in anemia of CKD. 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, 2020 and our Quarterly Report on Form 10-Q for quarter ended June 30, 2021 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.

    Investors:

    Michael Tung, M.D.

    Corporate Strategy / Investor Relations

    +1.415.978.1434

    mtung@fibrogen.com

    Media:

    GCI Health

    FibroGenMedia@gcihealth.com



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

    • Total roxadustat net sales in China of $52.8 million1 by FibroGen and the distribution entity jointly owned by FibroGen and AstraZeneca

    • Roxadustat Receives Positive Opinion from the CHMP of EMA for Patients with Anemia of CKD

    • Roxadustat Receives Negative Vote from FDA Advisory Committee for Patients with Anemia of CKD

    SAN FRANCISCO, Aug. 09, 2021 (GLOBE NEWSWIRE) -- FibroGen, Inc. (NASDAQ:FGEN) today reported financial results for the second quarter 2021 and provided an update on the Company's recent developments.

    "We continue to be energized by the performance of roxadustat in China, where we are seeing impressive adoption of roxadustat in a rapidly…

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

    • Total roxadustat net sales in China of $52.8 million1 by FibroGen and the distribution entity jointly owned by FibroGen and AstraZeneca

    • Roxadustat Receives Positive Opinion from the CHMP of EMA for Patients with Anemia of CKD

    • Roxadustat Receives Negative Vote from FDA Advisory Committee for Patients with Anemia of CKD

    SAN FRANCISCO, Aug. 09, 2021 (GLOBE NEWSWIRE) -- FibroGen, Inc. (NASDAQ:FGEN) today reported financial results for the second quarter 2021 and provided an update on the Company's recent developments.

    "We continue to be energized by the performance of roxadustat in China, where we are seeing impressive adoption of roxadustat in a rapidly expanding anemia of CKD market. In addition, the positive CHMP opinion in Europe brings roxadustat one step closer to patients in this important region," said Enrique Conterno, Chief Executive Officer, FibroGen. "We look forward to the European Commission decision following the positive CHMP opinion. On the other hand, we are disappointed with the FDA Cardiovascular and Renal Drugs Advisory Committee negative vote, and we will continue to work with our partner AstraZeneca and the FDA on a path forward."

    Recent Key Events and Other Developments

    Regulatory:

    • In June, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion relating to the use of roxadustat for the treatment of adult patients with symptomatic anemia associated with chronic kidney disease (CKD). A European Commission decision is expected in August 2021.
    • In July, the U.S. Food and Drug Administration (FDA) Cardiovascular and Renal Drugs Advisory Committee (CRDAC) voted to recommend not approving roxadustat for the treatment of anemia due to CKD. An FDA action on the new drug application is expected in the near future.

    _____________________________

    1 Total roxadustat net sales in China includes sales made by the distribution entity as well as FibroGen China's direct sales, each to its own distributors. The distribution entity jointly owned by AstraZeneca and FibroGen is not consolidated into FibroGen's financial statements.

    Clinical:

    China:

    • Roxadustat net product revenue in China of $13.4 million, on a US GAAP basis, including revenue generated from our sales to the distribution entity and FibroGen China's direct sales, compared to $15.4 million last quarter.
    • Total roxadustat net sales in China of $52.8 million by FibroGen and the distribution entity jointly owned by FibroGen and AstraZeneca, compared to $43.5 million last quarter.
    • Hospital listings at the end of the second quarter represented approximately 81% of the CKD anemia market opportunity in China versus 74% last quarter.

    Clinical Presentations / Publications:

    • FibroGen and its partners presented three roxadustat oral presentations and ten mini-oral presentations at the recent 58th European Renal Association-European Dialysis and Transplant Association (ERA-EDTA) Virtual Congress.
    • Two additional roxadustat Phase 3 manuscripts on the treatment of anemia of CKD were published in a peer-reviewed medical journal, bringing the total to 7:
    • FibroGen presented one oral presentation and one poster presentation of two-year data from a Phase 2 trial of pamrevlumab in non-ambulatory DMD patients at the recent Parent Project Muscular Dystrophy (PPMD) Annual Conference.

    Upcoming Data Milestones:

    • Data from the Phase 2 WHITNEY study of roxadustat in chemotherapy-induced anemia (CIA) expected 3Q 2021 versus prior 2H 2021.
    • Topline data from the Phase 3 MATTERHORN study of roxadustat in anemia of myelodysplastic syndromes (MDS) now expected 2H 2022 / 1H 2023 versus prior 1H 2022.
    • Interim analysis of event free survival for potential accelerated approval of Phase 3 LAPIS study of pamrevlumab in locally advanced pancreatic cancer (LAPC) will be completed in 2H 2022.
    • Topline data from the Phase 3 LELANTOS-1 study of pamrevlumab in Duchenne muscular dystrophy (DMD) now expected 1H 2023 versus prior 2H 2022.
    • Topline data from the Phase 3 ZEPHYRUS-1 study of pamrevlumab in idiopathic pulmonary fibrosis (IPF) expected mid-2023.

    Corporate

    • Appointed John Hunter, Ph.D. as Chief Scientific Officer.
    • FibroGen and HiFiBiO announced partnership to advance next-generation therapies for patients with cancer and autoimmune disease. FibroGen exclusively licensed HiFiBiO's Galectin-9 program, and obtained an exclusive option to their CXCR5 and CCR8 programs.
    • Eluminex Biosciences exclusively licensed worldwide rights to develop and commercialize FibroGen's investigational biosynthetic cornea program and the underlying recombinant human collagen Type III technology.
    • The Company has completed its internal review of the events leading to our April 6, 2021 disclosures in which we clarified that certain cardiovascular safety analyses from the roxadustat Phase 3 program for the treatment of anemia of chronic kidney disease included post-hoc changes to the stratification factors.

    Financial:

    • Total revenue for the second quarter of 2021 was $24.4 million, as compared to $42.9 million for the second quarter of 2020. The current quarter revenue includes $13.4 million net product revenue for roxadustat sales in China, and $19.6 million in development revenue. The current quarter also includes $(8.6) million drug product revenue as a result of the recent unfavorable CRDAC vote.
    • Operating costs and expenses for the second quarter of 2021 included a one-time charge of $25 million related to our partnership with HiFiBio, and an increase of approximately $20 million driven primarily by pamrevlumab development expenses compared to one year ago.
    • Net loss for the second quarter of 2021 was $134.0 million, or $1.45 net loss per basic and diluted share, compared to a net loss of $85.3 million, or $0.95 net loss per basic and diluted share one year ago.

    Conference Call and Webcast Details

    FibroGen will host a conference call and webcast today, Monday, August 9, 2021, at 5:00 p.m. Eastern Time (2:00 p.m. Pacific Time) to discuss financial results and provide a business update. A live audio webcast of the call may be accessed in the investor section of the Company's website, www.fibrogen.com. To participate in the conference call by telephone, please dial 1 (877) 658-9081 (U.S. and Canada) or 1 (602) 563-8732 (international), reference the FibroGen second quarter 2021 financial results conference call, and use confirmation number 4951789. A replay of the webcast will be available shortly after the call for a period of four weeks. To access the replay, please dial 1 (855) 859-2056 (domestic) or 1 (404) 537-3406 (international), and use passcode 4951789.

    About Roxadustat

    Roxadustat, an oral medicine, is the first in a new class of medicines, HIF-PH inhibitors, that promote erythropoiesis, or red blood cell production, through increased endogenous production of erythropoietin; improved iron absorption and mobilization; and downregulation of hepcidin. Roxadustat is also in clinical development for anemia associated with myelodysplastic syndromes (MDS) and for chemotherapy-induced anemia (CIA).

    Roxadustat is approved in China, Japan, Chile, and South Korea for the treatment of anemia of CKD in adult patients on dialysis (DD) and not on dialysis (NDD). In Europe, the Marketing Authorisation Application is under review by the European Medicines Agency (EMA). In the U.S., the New Drug Application is under review by the U.S. Food and Drug Administration. Several other licensing applications for roxadustat have been submitted by Astellas and AstraZeneca to regulatory authorities across the globe, and are currently in review.

    Astellas and FibroGen are collaborating on the development and commercialization of roxadustat for the potential treatment of anemia in territories including Japan, Europe, Turkey, Russia and 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 U.S., China, other markets in the Americas, in Australia/New Zealand, and Southeast Asia.

    About Pamrevlumab

    Pamrevlumab is a first-in-class antibody developed by FibroGen that inhibits the activity of connective tissue growth factor (CTGF), an important biological mediator in fibrotic and proliferative disorders. Pamrevlumab is in Phase 3 clinical development for the treatment of locally advanced unresectable pancreatic cancer (LAPC), Duchenne muscular dystrophy (DMD), and idiopathic pulmonary fibrosis (IPF). 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 for the treatment of 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 (CIA). Pamrevlumab, an anti-CTGF human monoclonal antibody, is in clinical development for the treatment of locally advanced unresectable pancreatic cancer (LAPC), Duchenne muscular dystrophy (DMD), and idiopathic pulmonary fibrosis (IPF). 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, 2020 and our Quarterly Report on Form 10-Q for quarter ended June 30, 2021 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.

    Condensed Consolidated Balance Sheets

    (In thousands)

     June 30, 2021  December 31, 2020 
     (Unaudited)  (1) 
    Assets       
    Current assets:       
    Cash and cash equivalents$353,361  $678,393  
    Short-term investments 153,851   8,144  
    Accounts receivable, net 24,266   41,883  
    Inventory 24,530   16,530  
    Prepaid expenses and other current assets 8,458   10,160  
    Total current assets 564,466   755,110  
            
    Restricted time deposits 2,072   2,072  
    Long-term investments 105,758   244  
    Property and equipment, net 30,670   33,647  
    Finance lease right-of-use assets 861   29,606  
    Equity method investment in unconsolidated variable interest entity 3,083   2,728  
    Operating lease right-of-use assets 97,091   2,043  
    Other assets 4,617   1,390  
    Total assets$808,618  $826,840  
            
    Liabilities, stockholders' equity and non-controlling interests       
    Current liabilities:       
    Accounts payable$48,988  $24,789  
    Accrued and other liabilities 147,801   118,333  
    Deferred revenue 25,234   6,547  
    Finance lease liabilities, current 23   12,330  
    Operating lease liabilities, current 10,718   1,188  
    Total current liabilities 232,764   163,187  
            
    Product development obligations 18,277   18,697  
    Deferred revenue, net of current 152,865   138,474  
    Finance lease liabilities, non-current 6   25,391  
    Operating lease liabilities, non-current 94,196   853  
    Other long-term liabilities 30,659   38,789  
    Total liabilities 528,767   385,391  
            
    Total stockholders' equity 260,580   422,178  
    Non-controlling interests 19,271   19,271  
    Total equity 279,851   441,449  
    Total liabilities, stockholders' equity and non-controlling interests$808,618  $826,840  

    (1)   The condensed consolidated balance sheet amounts at December 31, 2020 are derived from audited financial statements.





    Condensed Consolidated Statements of Operations

    (In thousands, except per share data)

     Three Months Ended June 30,  Six Months Ended June 30, 
     2021  2020  2021  2020 
     (Unaudited) 
    Revenue:               
    License revenue$  $  $  $ 
    Development and other revenue 19,641   18,957   34,228   38,402 
    Product revenue, net 13,371   15,693   28,733   20,648 
    Drug product revenue (8,648)  8,238   (168)  8,238 
    Total revenue 24,364   42,888   62,793   67,288 
    Operating costs and expenses:               
    Cost of goods sold 3,078   3,076   6,479   4,047 
    Research and development 122,567   61,414   197,243   116,315 
    Selling, general and administrative 32,554   63,535   63,334   113,138 
    Total operating costs and expenses 158,199   128,025   267,056   233,500 
    Loss from operations (133,835)  (85,137)  (204,263)  (166,212)
    Interest and other, net:               
    Interest expense (355)  (651)  (856)  (1,284)
    Interest income and other income (expenses), net (363)  644   (817)  3,810 
    Total interest and other, net (718)  (7)  (1,673)  2,526 
    Loss before income taxes (134,553)  (85,144)  (205,936)  (163,686)
    Provision for income taxes (3)  169   130   (25)
    Investment income in unconsolidated variable interest entity 562      323    
    Net loss$(133,988) $(85,313) $(206,066) $(163,661)
                    
    Net loss per share - basic and diluted$(1.45) $(0.95) $(2.24) $(1.84)
                    
    Weighted average number of common shares used to calculate net loss per share - basic and diluted 92,276   89,451   91,983   88,835 

    Contacts:

    FibroGen, Inc.

    Investors:

    Michael Tung, M.D.

    Corporate Strategy / Investor Relations

    415.978.1434

    mtung@fibrogen.com

    Media:

    GCI Health

    FibroGenMedia@gcihealth.com



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