FibroGen

FibroGen, Inc. is a biopharmaceutical company, which engages in the discovery, development, and commercialization of novel therapeutics. It focuses on the hypoxia-inducible factor and connective tissue growth factor biology to develop medicines for the treatment of anemia, fibrotic disease, and cancer. The company was founded by Thomas B. Neff on September 29, 1993 and is headquartered in San Francisco, CA.

Earnings data Q1 2021

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Earnings data Q4 2024

FibroGen reports improved financials and readies for new therapy launches

FibroGen's financials improved in Q4 2022, with strong cash reserves.
Strategic focus on new therapy launches and pivotal Phase 3 data.
Progress in commercial manufacturing and readiness for potential launches.
Emphasis on FDA feedback for filing strategies and multiple efficacy endpoints.

FibroGen reports Q1 revenue growth, faces challenges in study results

FibroGen's Q1 2023 performance showed strong revenue but faced challenges with roxadustat's Phase 3 study results.
The company's strengths lie in commercial opportunities, financial stability, and adherence to rigorous data analysis methods.
Challenges include addressing study result concerns and uncertainties in funding tied to clinical milestones.
Opportunities exist in market expansion, especially in IPF treatment, and upcoming Phase 3 trials for pamrevlumab.

FibroGen reports revenue growth amidst challenges and promising opportunities

FibroGen's Q2 2023 performance showed revenue growth and cost reduction efforts.
The company faces challenges in pamrevlumab trials and patent validity issues in China.
However, opportunities lie in upcoming trial readouts and the early-stage oncology pipeline.
FibroGen's strategic pillars and commitment to cost savings are key strengths.

FibroGen reports robust Q3 earnings, eyes expansion amid market challenges

FibroGen's Q3 performance was strong, driven by revenue growth and promising trial results.
The company's strategic pillars and clear pricing strategies position it well for future growth.
While facing challenges like generic competition, FibroGen has opportunities for expansion and market differentiation.
Overall, FibroGen's financial health and pipeline developments indicate a positive outlook for the company.

FibroGen reports robust Q4 performance and eyes expansion opportunities

FibroGen's Q4 2023 earnings call showcased strong performance in China for roxadustat and provided a detailed financial update, addressing key inquiries from analysts.
The company's strategic pillars, emphasis on highest tolerable doses for efficacy, and promising Phase I results position FibroGen well for future growth and drug development.
While challenges exist in interpreting data and prioritizing studies, opportunities in expanding market reach, refining development strategies, and enhancing efficacy markers are evident.
Overall, FibroGen's proactive approach to addressing challenges and exploring opportunities underscores a commitment to innovation and growth in the pharmaceutical sector.

FibroGen reports robust earnings, eyes growth in China and oncology

FibroGen's Q1 2024 earnings call highlighted strong financial performance, promising drug developments, cost efficiencies, and strategic focus on future growth. Despite challenges like market competition and regulatory timelines, the company remains optimistic and proactive in pursuing opportunities for expansion.

FibroGen reports strong Q3 performance in China, eyes growth

FibroGen's Q3 2024 results reflect notable growth in Roxadustat sales in China, cost reductions, and improved financial performance, positioning the company for future success.
Despite facing challenges such as expense management and market uncertainties, FibroGen's strategic pillars, positive outlook, and cash reserves offer resilience and growth potential.
Opportunities lie in market expansion, innovation, and partnerships, signaling a promising trajectory for FibroGen to capitalize on its strengths and drive value creation.

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FibroGen, Inc. is a biopharmaceutical company, which engages in the discovery, development, and commercialization of novel therapeutics. It focuses on the hypoxia-inducible factor and connective tissue growth factor biology to develop medicines for the treatment of anemia, fibrotic disease, and cancer. The company was founded by Thomas B. Neff on September 29, 1993, and is headquartered in San Francisco, CA.

SAN FRANCISCO, Feb.  11, 2020  (GLOBE NEWSWIRE) -- FibroGen, Inc. (NASDAQ:FGEN) today announced that the U.S. Food and Drug Administration (FDA) has completed its filing review of its New Drug Application (NDA) for roxadustat for the treatment of anemia of chronic kidney disease (CKD), in both non-dialysis-dependent (NDD) and dialysis-dependent (DD) patients. The application will be considered filed on February 18, 2020. The FDA has set a Prescription Drug User Fee Act (PDUFA) date of December 20, 2020. 

FibroGen Announces U.S. FDA Acceptance of New Drug Application for Roxadustat for the Treatment of Anemia of Chronic Kidney Disease

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The former Eli Lilly executive will be tasked with launching the biotech's anemia drug roxadustat.

FibroGen Appoints Enrique Conterno as Its New CEO

Conterno brings global pharmaceutical leadership from his three decades of industry experience Conterno brings global pharmaceutical leadership from his three decades of industry experience

FibroGen Names Enrique Conterno as Chief Executive Officer

Investors need to pay close attention to FibroGen (FGEN) stock based on the movements in the options market lately.

Are Options Traders Betting on a Big Move in FibroGen (FGEN) Stock?

New Drug Application supported by positive global Phase 3 efficacy and safety results New Drug Application supported by positive global Phase 3 efficacy and safety results

FibroGen Submits New Drug Application to the U.S. FDA for Roxadustat in Patients With Anemia of Chronic Kidney Disease

SAN FRANCISCO, Dec.  02, 2019  (GLOBE NEWSWIRE) -- FibroGen, Inc. (NASDAQ: FGEN) today reported roxadustat has been included on the updated National Reimbursement Drug List (NRDL) released by China’s National Healthcare Security Administration (NHSA). Roxadustat is included on the NRDL for the treatment of anemia in chronic kidney disease (CKD), covering patients who are non-dialysis-dependent (NDD) as well as those who are dialysis-dependent (DD).

FibroGen Announces Roxadustat Inclusion in China’s National Reimbursement Drug List

FibroGen, Inc. (FGEN) CEO James Schoeneck on Q3 2019 Results - Earnings Call Transcript

FibroGen Overcomes Safety Hurdle; Clear Path Towards FDA Approval For CKD Patients

FibroGen reported highly anticipated clinical data on Friday for its lead drug roxadustat in chronic kidney disease.

Here’s Why FibroGen’s Stock Popped Friday

FibroGen (FGEN) saw a big move last session, as its shares jumped nearly 10% on the day, amid huge volumes.

FibroGen (FGEN) Soars: Stock Adds 9.6% in Session

Roxadustat cardiovascular safety comparable to placebo in non-dialysis dependent (NDD) patients, as assessed by Major Adverse Cardiovascular Events (MACE) and MACE+

FibroGen Announces Positive Phase 3 Pooled Roxadustat Safety and Efficacy Results for Treatment of Anemia in Chronic Kidney Disease

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SAN FRANCISCO, Oct.  23, 2019  (GLOBE NEWSWIRE) -- FibroGen, Inc. (NASDAQ: FGEN), today announced the dosing of the first patient in the LAPIS Phase 3 clinical study of pamrevlumab in patients with unresectable locally advanced pancreatic cancer (LAPC).

FibroGen Announces First Patient Dosed in LAPIS, a Phase 3 Clinical Trial of Pamrevlumab for the Treatment of Patients With Locally Advanced Pancreatic Cancer  

Shares have risen by 80% since my initial recommendation, but are in the red by over 20% since my last update.

FibroGen: Updates To Thesis, Clinical And Regulatory Catalysts Loom

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Pooled efficacy and cardiovascular safety of roxadustat, compared to epoetin alfa (EPO) in CKD patients on dialysis and compared to placebo in CKD patients not on dialysis, to be presented as late-breaker Pooled efficacy and cardiovascular safety of roxadustat, compared to epoetin alfa (EPO) in CKD patients on dialysis and compared to placebo in CKD patients not on dialysis, to be presented as late-breaker

Roxadustat Global Phase 3 Results for Treatment of Chronic Kidney Disease (CKD) Anemia to be Presented at American Society of Nephrology Kidney Week 2019

SAN FRANCISCO, Oct.  07, 2019  (GLOBE NEWSWIRE) -- FibroGen, Inc. (NASDAQ: FGEN) is pleased to announce that William G. Kaelin, Jr., who serves on the company’s Scientific Advisory Board, has been awarded the 2019 Nobel Prize in Physiology or Medicine.

FibroGen Congratulates Dr. William G.

FibroGen, Inc. (FGEN) has been on a bit of a cold streak lately, but there might be light at the end of the tunnel for this overlooked stock.

FibroGen Enters Oversold Territory

SAN FRANCISCO, Sept.  30, 2019  (GLOBE NEWSWIRE) -- FibroGen, Inc. (NASDAQ: FGEN) today announced that roxadustat received the 2019 Dushu Lake Prize 独墅湖杯in China for “On-Market Innovative Drug with Highest Clinical Value.”  The award was received by its subsidiary FibroGen (China) Medical Technology Development Company, Ltd., of Beijing.

FibroGen Receives One of China Pharmaceutical Industry’s Highest Awards for Clinical Innovation for Roxadustat

-- Novel Human Antibody Targets CTGF, A Central Mediator in Fibrosis --   SAN FRANCISCO, Sept.  30, 2019  (GLOBE NEWSWIRE) -- FibroGen, Inc. (NASDAQ: FGEN) today announced publication in The Lancet Respiratory Medicine of positive results from the company’s PRAISE Phase 2 clinical study of the efficacy and safety of pamrevlumab, a fully human recombinant monoclonal antibody against connective tissue growth factor (CTGF), for treatment of idiopathic pulmonary fibrosis (IPF). The publication, entitled, “Pamrevlumab (FG-3019), an anti-connective tissue growth factor therapy for idiopathic pulmonary fibrosis: a randomized, double-blind, placebo-controlled trial,” is available online.1

FibroGen Announces Publication in the Lancet Respiratory Medicine of Positive Pamrevlumab Efficacy and Safety Data for the Praise Phase 2 Study in Idiopathic Pulmonary Fibrosis

FibroGen (FGEN) doses the first patient in a phase II study on roxadustat for the treatment of anemia in cancer patients receiving chemotherapy.

FibroGen Begins Study on Roxadustat for Chemo-Induced Anemia

SAN FRANCISCO, Sept.  26, 2019  (GLOBE NEWSWIRE) -- FibroGen, Inc. (NASDAQ: FGEN) today announced first patient dosed in the company’s Phase 2 clinical study of roxadustat, a first-in-class hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI), for the treatment of chemotherapy-induced anemia (CIA) in cancer patients receiving chemotherapy.

FibroGen Announces Initiation of Phase 2 Clinical Trial of Roxadustat for the Treatment of Anemia in Cancer Patients Receiving Chemotherapy

FibroGen's (FGEN) Evrenzo (roxadustat) wins a marketing approval in Japan for treating anemia caused by chronic kidney disease in dialysis-dependent patients.

News for FibroGen Stock (FGEN)