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 Q4 2020

Earnings data Q1 2021

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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.

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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, Nov. 04, 2024 (GLOBE NEWSWIRE) -- FibroGen, Inc. (NASDAQ: FGEN) will announce third quarter 2024 financial results on Tuesday, November 12 after the market close. FibroGen will also conduct a conference call on that day at 5:00 PM Eastern Time with the investment community to further detail the company's corporate and financial performance.

FibroGen to Report Third Quarter 2024 Financial Results

FibroGen, Inc. (NASDAQ:FGEN ) Q2 2024 Earnings Conference Call August 6, 2024 5:00 PM ET Company Participants David DeLucia - CFA Vice President, Corporate FP&A & Investor Relations Thane Wettig - Chief Executive Officer Deyaa Adib - Chief Medical Officer Juan Graham - Chief Financial Officer Chris Chung - Senior Vice President, China Operations Conference Call Participants Dalton Greenwood - William Blair Dina Ramadane - Bank of America Paul Choi - Goldman Sachs Operator Good day and welcome to the FibroGen Second Quarter 2024 Earnings Conference Call. All participants will be in a listen-only mode.

FibroGen, Inc. (FGEN) Q2 2024 Earnings Call Transcript

FibroGen (FGEN) came out with a quarterly loss of $0.16 per share versus the Zacks Consensus Estimate of a loss of $0.26. This compares to loss of $0.65 per share a year ago.

FibroGen (FGEN) Reports Q2 Loss, Tops Revenue Estimates

FibroGen Inc. FGEN saw its share price plummet after the release of topline results from two late-stage trials evaluating the efficacy and safety of pamrevlumab in pancreatic cancer patients.

One Year, Five Trial Failures: FibroGen Terminates Pancreatic Cancer Treatment Program

FibroGen (NASDAQ: FGEN ) layoffs are in the news Wednesday after the biopharmaceutical company announced plans to cut jobs after failed clinical trials. FibroGen says that it is going into a cost-saving mode that will result in layoffs for 75% of its U.S. employees.

FibroGen Layoffs 2024: What to Know About the Latest FGEN Job Cuts

FibroGen (NASDAQ: FGEN ) stock is falling hard on Wednesday after the biopharmaceutical company reported results from failed clinical trials. The first failed clinical trial covers the treatment of metastatic pancreatic cancer with pamrevlumab.

Why Is FibroGen (FGEN) Stock Down 44% Today?

SAN FRANCISCO, July 30, 2024 (GLOBE NEWSWIRE) -- FibroGen, Inc. (NASDAQ: FGEN) will announce second quarter 2024 financial results on Tuesday, August 6 after the market close. FibroGen will also conduct a conference call on that day at 5:00 PM Eastern Time with the investment community to further detail the company's corporate and financial performance.

FibroGen to Report Second Quarter 2024 Financial Results

FibroGen, Inc. top-line data from the phase 2/3 PanCAN Precision Promise study, using pamrevlumab for the treatment of patients with metastatic pancreatic cancer, expected mid-2024. Topline data from the phase 3 LAPIS study, using pamrevlumab for the treatment of patients with locally advanced unresectable pancreatic cancer, expected Q3 of 2024. Initiation of phase 2 monotherapy dose optimization study of FG-3246 for the treatment of patients with metastatic castration-resistant prostate cancer, expected 2nd half of 2024.

FibroGen: Two New In-Licensed Oncology Drugs To Carry It Forward

SAN FRANCISCO, June 03, 2024 (GLOBE NEWSWIRE) -- FibroGen, Inc. (NASDAQ: FGEN) today announced a clinical trial supply agreement with Regeneron Pharmaceuticals to evaluate FibroGen's immuno-oncology assets, FG-3165 and FG-3175, in combination with Regeneron's anti-PD-1 therapy, LIBTAYO® (cemiplimab), in patients with solid tumors.

FibroGen Announces Clinical Trial Supply Agreement with Regeneron Pharmaceuticals to Evaluate FibroGen's Immuno-Oncology Assets, FG-3165 (anti-Galectin 9) and FG-3175 (anti-CCR8), in Combination with LIBTAYO® in Upcoming Clinical Trials

SAN FRANCISCO, June 03, 2024 (GLOBE NEWSWIRE) -- FibroGen, Inc. (NASDAQ: FGEN) today announced that the U.S. Food and Drug Administration (FDA) has cleared the Company's Investigational New Drug (IND) of FG-3165, a galectin-9 (Gal9) targeted monoclonal antibody under development for treatment of solid tumors characterized by high Gal9 levels of expression.

FibroGen Announces FDA Clearance of Investigational New Drug Application for FG-3165, a Galectin-9 Targeting Monoclonal Antibody, for the Treatment of Patients with Solid Tumors

Affimed

Anixa Biosciences Inc

Genenta Science S.P.A.

Lipocine

Nuvectis Pharma

Relmada Therapeutics Inc

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SAN FRANCISCO, May 23, 2024 (GLOBE NEWSWIRE) -- FibroGen, Inc. (NASDAQ: FGEN) today announced positive interim results from the dose escalation portion of the investigator-sponsored Phase 1b/2 study conducted by the University of California San Francisco of FG-3246 (FOR46), a potential first-in-class anti-CD46 antibody drug conjugate (ADC) with a MMAE-containing payload, in combination with enzalutamide in patients with metastatic castration resistant prostate cancer (mCRPC) at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting.

FibroGen Announces Presentation of Positive Interim Data from the Phase 1b Study of FG-3246 (FOR46) in Combination with Enzalutamide in Patients with Metastatic Castration Resistant Prostate Cancer (mCRPC) at the 2024 American Society of Clinical Oncology

SAN FRANCISCO, May 07, 2024 (GLOBE NEWSWIRE) -- FibroGen, Inc. (NASDAQ: FGEN) today announced that the company's management will participate in the following investor conferences:

FibroGen to Participate in Upcoming Investor Conferences

FibroGen, Inc. (NASDAQ:FGEN ) Q1 2024 Earnings Conference Call May 6, 2024 5:00 PM ET Company Participants David DeLucia - VP, Corporate FP&A and IR Thane Wettig - CEO Deyaa Adib - CMO Juan Graham - CFO Chris Chung - SVP, China Operations Conference Call Participants Andy Hsieh - William Blair Paul Choi - Goldman Sachs Operator Good day and thank you for standing by. Welcome to the FibroGen's First Quarter 2024 Earnings Conference Call.

FibroGen, Inc. (FGEN) Q1 2024 Earnings Call Transcript

SAN FRANCISCO, May 06, 2024 (GLOBE NEWSWIRE) -- FibroGen, Inc. (NASDAQ: FGEN) today reported financial results for the first quarter 2024 and provided an update on the company's recent developments.

FibroGen Reports First Quarter 2024 Financial Results

SAN FRANCISCO, April 29, 2024 (GLOBE NEWSWIRE) -- FibroGen, Inc. (NASDAQ: FGEN) will announce first quarter 2024 financial results on Monday, May 6 after the market close. FibroGen will also conduct a conference call on that day at 5:00 PM Eastern Time with the investment community to further detail the company's corporate and financial performance.

FibroGen to Report First Quarter 2024 Financial Results

SAN FRANCISCO, April 24, 2024 (GLOBE NEWSWIRE) -- FibroGen, Inc. (NASDAQ: FGEN) today announced that clinical data from the dose escalation portion of the Phase 1b/2 study of FG-3246 in combination with enzalutamide in patients with metastatic castration resistant prostate cancer have been selected for a poster presentation at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting taking place May 31-June 4, 2024 in Chicago, Illinois.

FibroGen Announces Clinical Data from Dose Escalation Phase 1b Study of FG-3246 (FOR46) in Combination with Enzalutamide in Patients with Metastatic Castration Resistant Prostate Cancer will be Presented at the 2024 American Society of Clinical Oncology A

SAN FRANCISCO, April 02, 2024 (GLOBE NEWSWIRE) -- FibroGen, Inc. (NASDAQ: FGEN) today announced topline data from the Fortis Therapeutics-sponsored Phase 1 study of FG-3246 (also known as FOR46), a potential first-in-class anti-CD46 antibody drug conjugate (ADC) with an MMAE-containing payload, in a dose-escalation and dose-expansion trial enrolling patients with metastatic castration-resistant prostate cancer (mCRPC) whose tumors have progressed on at least one androgen receptor-signaling inhibitor (ARSI).

FibroGen Announces Topline Results from Phase 1 Monotherapy Study of FG-3246 in Patients with Metastatic Castration-Resistant Prostate Cancer

SAN FRANCISCO, March 26, 2024 (GLOBE NEWSWIRE) -- FibroGen, Inc. (NASDAQ: FGEN) today announced that Thane Wettig, Chief Executive Officer, will participate in a corporate presentation at the 23rd Annual Needham Virtual Healthcare Conference on Tuesday, April 9, 2024, from 3:00-3:40 PM Eastern Time. Company management will also participate in virtual one-on-one meetings with investors during the conference.

FibroGen to Present at 23rd Annual Needham Virtual Healthcare Conference

TrustCo Bank

Xerox

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SAN FRANCISCO, March 11, 2024 (GLOBE NEWSWIRE) -- FibroGen, Inc. (NASDAQ: FGEN) today announced the appointment of Deyaa Adib, M.D., an executive leader with almost three decades of oncology development experience, as Senior Vice President & Chief Medical Officer to oversee all global clinical development activities. The appointment is effective March 11, 2024.

FibroGen Appoints Deyaa Adib, M.D. as Chief Medical Officer

FibroGen, Inc. (FGEN) Q4 2023 Earnings Call Transcript

AstraZeneca

FibroGen Inc said on Monday it is regaining rights to the anemia drug, roxadustat, from AstraZeneca after the companies mutually agreed to terminate their collaboration agreement.

FibroGen regains rights to anemia drug from AstraZeneca

•   Topline data from two pivotal pamrevlumab pancreatic cancer trials anticipated in 2Q 2024 •   Additional data from Phase 1 monotherapy study of FG-3246 in metastatic castration-resistant prostate cancer (mCRPC) expected in 1Q 2024 •   FibroGen regains rights to roxadustat from AstraZeneca in the United States and other AstraZeneca territories, except China and South Korea •   FY 2023 total net revenue of $147.8 million, an increase of 5% year over year •   Robust roxadustat volume growth of 41% in China in FY 2023 compared to FY 2022 •   Successful execution of cost reduction plan; $248.1 million in cash provides cash runway into 2026 SAN FRANCISCO, Feb. 26, 2024 (GLOBE NEWSWIRE) -- FibroGen, Inc. (NASDAQ: FGEN) today reported financial results for the fourth quarter and full year 2023 and provided an update on the company's recent developments. “We are extremely excited about the company's prospects in 2024,” said Thane Wettig, Chief Executive Officer, FibroGen.

FibroGen Reports Fourth Quarter and Full Year 2023 Financial Results

The FibroGen – AstraZeneca China Agreement for Roxadustat remains in place FibroGen to explore licensing opportunities for Roxadustat SAN FRANCISCO, Feb. 26, 2024 (GLOBE NEWSWIRE) -- FibroGen, Inc. (NASDAQ: FGEN) announced today that FibroGen and AstraZeneca have agreed to terminate the U.S./RoW roxadustat collaboration agreement entered into on July 30, 2013, under which AstraZeneca held development and commercialization rights in the United States and other territories outside of China not licensed to Astellas Pharma Inc. Pursuant to a termination and transition agreement entered into between the parties, AstraZeneca is returning all U.S./RoW roxadustat rights to FibroGen (with the exception of South Korea) and providing certain assistance during a transition period. FibroGen's collaboration agreement with AstraZeneca for roxadustat in China remains in place and roxadustat remains the leader in China by brand value share in the chronic kidney disease (CKD) anemia category.

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