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.

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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.

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Photo credit sergeitokmakov @ Pixabay Trading against the trend can be a very difficult way to generate returns in the market, yet there usually comes a time when a stock in a downtrend simply runs out of sellers.

3 Beaten Down Stocks that Could be Ready to Bounce

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.

FibroGen Announces Retirement of Pat Cotroneo and Appointment of Juan Graham as Chief Financial Officer

NDA for roxadustat, FibroGen's (FGEN) candidate for anemia of chronic kidney disease, fails to secure approval as the FDA requests additional clinical data on the drug. The stock declines resultantly.

FibroGen's (FGEN) Drug for Anemia of CKD Gets CRL From FDA

The FDA has issued a complete response letter regarding the marketing application for FibroGen Inc's (NASDAQ: FGEN) roxadustat for anemia of chronic kidney disease (CKD). The letter indicates the FDA will not approve the roxadustat NDA in its present form and has requested an additional clinical study of roxadustat be conducted.

FibroGen Shares Are Trading Lower As FDA Shoots Down Roxadustat Application, Asks For Additional Trial

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).

FibroGen Receives Complete Response Letter from the FDA for Roxadustat for Anemia of Chronic Kidney Disease

FibroGen, Inc. (FGEN) CEO Enrique Conterno on Q2 2021 Results - Earnings Call Transcript

FibroGen (FGEN) delivered earnings and revenue surprises of -202.08% and -68.93%, respectively, for the quarter ended June 2021. Do the numbers hold clues to what lies ahead for the stock?

FibroGen (FGEN) Reports Q2 Loss, Lags Revenue Estimates

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

FibroGen Reports Second Quarter 2021 Financial Results

FibroGen (FGEN) is seeing favorable earnings estimate revision activity and has a positive Zacks Earnings ESP heading into earnings season.

Why FibroGen (FGEN) Might Surprise This Earnings Season

FibroGen (FGEN) possesses the right combination of the two key ingredients for a likely earnings beat in its upcoming report. Get prepared with the key expectations.

FibroGen (FGEN) Expected to Beat Earnings Estimates: What to Know Ahead of Q2 Release

FDA approval of roxadustat seems unlikely.

What's Next for FibroGen After an FDA Vote Against Its Anemia Drug?

Eluminex Biosciences (Suzhou) Limited has exclusively licensed global rights to develop and commercialize a biosynthetic cornea from FibroGen Inc (NASDAQ: FGEN). The biosynthetic cornea is derived from recombinant human collagen Type III and is intended to treat patients with corneal blindness.

FibroGen Out-Licenses Recombinant Human Collagen-Based Biosynthetic Cornea

SUZHOU, China and SAN FRANCISCO, July 19, 2021 (GLOBE NEWSWIRE) -- Eluminex Biosciences (Suzhou) Limited (Eluminex), an ophthalmology-focused biotechnology company headquartered in Suzhou, China with a US-subsidiary office in San Francisco Bay Area, California, announced today that it has exclusively licensed global rights for the development and commercialization of an investigational biosynthetic cornea derived from recombinant human collagen Type III intended to treat patients with corneal blindness, from FibroGen, Inc. (FibroGen; NASDAQ: FGEN).

Eluminex Biosciences Exclusively Licenses FibroGen's Biosynthetic Cornea Technology and Recombinant Collagen III Platform

An FDA advisory committee made it clear that they don't want the agency to approve roxadustat due to safety concerns.

Here's Why FibroGen Stock Is Plunging Today

FibroGen (FGEN) stock is falling hard on Friday after the company received the results of an FDA review for one of its drugs. The post FGEN Stock: The Huge FDA News Causing FibroGen Shares to Free Fall appeared first on InvestorPlace.

FGEN Stock: The Huge FDA News Causing FibroGen Shares to Free Fall

FibroGen (FGEN) is seeking approval for roxadustat as potential treatment of anemia of chronic kidney disease in the United States. Stock down on unfavorable advisory committee outcome.

FibroGen (FGEN) Roxadustat Fails to Win FDA Advisory Panel Vote

FibroGen, Inc. (NASDAQ: FGEN) shares are trading lower after an FDA Advisory Committee panel voted against approval of the company's New Drug Application for roxadustat to treat anemia due to chronic kidney disease in adult patients. 'While we are disappointed with today's outcome,' said CEO Enrique Conterno, 'we believe the scientific evidence supports roxadustat approval in the U.S. and will work with the FDA as it completes its review of the New Drug Application for roxadustat.

Why FibroGen's Stock Is Getting Hammered Today

AstraZeneca

AstraZeneca PLC has disclosed Friday that a U.S. Food and Drug Administration advisory committee has voted 13 to 1 not to support approval of roxadustat for the treatment of anaemia in chronic kidney disease (CKD) in non-dialysis dependent adult patients. Shares of FibroGen Inc. , which was AstraZeneca's partner in developing roxadustat, plummeted 34.1% in premarket trading, while AstraZeneca's U.S.-listed shares edged up 0.4%.

AstraZeneca says FDA advisory committee won't support CKD treatment for approval, partner FibroGen stock plunges

FibroGen, Inc.'s (NASDAQ: FGEN) shares are sinking to their lowest level since late June 2016. FibroGen's AdCom Snub  FibroGen said late Thursday the Food and Drug Administration's Cardiovascular and Renal Drugs Advisory Committee met to discuss the new drug application for roxadustat, voted against approval of the drug.

FibroGen Staring At Multi-Year Lows Following Adverse Roxadustat AdCom Verdict; How Hard Will The Stock Likely Fall?

Yesterday, the U.S. FDA voted not to approve Roxadustat for the treatment of anemia due to chronic kidney disease in adult patients.

FibroGen Stock Craters After Roxadustat Setback, But There Is A Silver Lining

AstraZeneca PLC (LON:AZN) is facing rejection from the US drug regulator for its application for a novel new drug to treat anaemia resulting from chronic kidney disease. The Food and Drug Administration's (FDA) Cardiovascular and Renal Drugs Advisory Committee voted against approving Roxadustat on the basis of its benefit-risk profile for both non-dialysis dependent and dialysis-dependent adult patients.

AstraZeneca and FibroGen face FDA red light over anaemia drug

SAN FRANCISCO, July 15, 2021 (GLOBE NEWSWIRE) -- FibroGen, Inc. (NASDAQ: FGEN) today announced that the U.S. Food and Drug Administration (FDA) Cardiovascular and Renal Drugs Advisory Committee (CRDAC) voted to recommend not approving roxadustat, an oral hypoxia-inducible factor prolyl hydroxylase (HIF-PH) inhibitor, for the treatment of anemia due to chronic kidney disease (CKD) in adult patients. The Committee based its recommendation on data from a global Phase 3 program encompassing more than 8,000 patients. While the FDA is not required to follow the Committee's vote, the agency considers the Committee's non-binding recommendations when making its decision.

FibroGen Announces Outcome of FDA Advisory Committee Review of Roxadustat for Treatment of Anemia of Chronic Kidney Disease

FibroGen, Inc. (NASDAQ:FGEN) has a key catalyst Thursday when FDA's Cardiovascular and Renal Drugs Advisory Committee will issue its recommendation on the company's new drug application for roxadustat. The committee is scheduled to meet between 9:30 a.m.

What 3 FibroGen Analysts Are Expecting From Thursday's Roxadustat Adcom Verdict

Ahead of Thursday's meeting of the FDA's Cardiovascular and Renal Drugs Advisory Committee, the agency is raising fresh doubts on the safety of AstraZeneca Plc's (NASDAQ: AZN) and FibroGen Inc's (NASDAQ: FGEN) anemia drug roxadustat. FDA staffers flagged concerning evidence of blood clotting, when compared with placebo in nondialysis-dependent patients but also when compared against Amgen Inc (NASDAQ: AMGN) and Johnson & Johnson's (NYSE: JNJ) Epogen/Procrit, "which is itself known to pose these risks," in dialysis-dependent patients.

Ahead Of AdComm AstraZeneca, FibroGen's Roxadustat Hit With Safety, Efficacy Questions

SAN FRANCISCO, July 12, 2021 (GLOBE NEWSWIRE) -- FibroGen, Inc. (NASDAQ: FGEN) announced the appointment of John Hunter, Ph.D., to the position of Chief Scientific Officer, where he will lead FibroGen's research efforts, leveraging more than 20 years of global biopharmaceutical leadership and experience.

News for FibroGen Stock (FGEN)