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ACCESSWIRE
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Active-Investors: Wired News - FDA Granted Fast Track Designation to FibroGen's Pamrevlumab for Locally Advanced Unresectable Pancreatic Cancer

Stock Monitor: G1 Therapeutics Post Earnings Reporting

LONDON, UK / ACCESSWIRE / March 05, 2018 / Active-Investors.com has just released a free research report on FibroGen, Inc. (NASDAQ: FGEN). If you want access to this report all you need to do is sign up now by clicking the following link www.active-investors.com/registration-sg/'symbol=FGEN as the Company's latest news hit the wire. On March 01, 2018, the Company declared that the US Food and Drug Administration (FDA) has granted Fast Track designation for the company's anti-CTGF antibody, pamrevlumab, for the treatment of patients with locally advanced unresectable pancreatic cancer. This follows review of the Phase-2 clinical trial evaluating pamrevlumab in combination with gemcitabine and nab-paclitaxel. Register today and get access to over 1,000 Free Research Reports by joining our site below:

www.active-investors.com/registration-sg

Active-Investors.com is currently working on the research report for G1 Therapeutics, Inc. (NASDAQ: GTHX), which also belongs to the Healthcare sector as the Company FibroGen. Do not miss out and become a member today for free to access this upcoming report at:

www.active-investors.com/registration-sg/'symbol=GTHX

Active-Investors.com is focused on giving you timely information and the inside line on companies that matter to you. This morning, FibroGen most recent news is on our radar and our team decided to put out a fantastic report on the company that is now available for free below:

www.active-investors.com/registration-sg/'symbol=FGEN

Fast Track designation is intended to facilitate the development and review of drugs used to treat serious conditions and to fill an unmet medical need.

The Designation is an Important Milestone for Pamrevlumab Program

Peony Yu, M.D., Chief Medical Officer of FibroGen, stated that the Company is encouraged by its Phase-2 study results, where the combination of pamrevlumab with chemotherapy changed eligibility for surgical resection in most treated patients who were previously not candidates for surgery.

Peony added that this designation is an important milestone for pamrevlumab program and has the potential to speed FibroGen's ability to advance pamrevlumab to patients.

FDA Granted Orphan Drug Designation Status to Pamrevlumab for Treatment of Pancreatic Cancer

In June 2017, the FDA also granted Orphan Drug Designation status to pamrevlumab for the treatment of pancreatic cancer. Orphan Drug Designation qualifies the sponsor for various development incentives of the Orphan Drug Act, including tax credits for qualified clinical testing, to advance the evaluation and development of products that demonstrate promise for the diagnosis and treatment of rare diseases or conditions.

FibroGen Announced Publication of Pamrevlumab Clinical Data in Pancreatic Cancer in Combination with Chemotherapy

In February 2017, the Company announced clinical results from its open-label, dose-escalation Phase-1/2 study of pamrevlumab in pancreatic cancer. The results supported a dose-related increase in survival in advanced pancreatic cancer, and that pamrevlumab could be safely combined with chemotherapy. In the trial, the safety and efficacy of increasing doses of pamrevlumab were evaluated in combination with two chemotherapy agents, gemcitabine and erlotinib, in 75 patients with previously untreated Stage III or Stage IV pancreatic ductal adenocarcinoma. Pamrevlumab was well tolerated with no dose-limiting toxicity observed and no dose-related trends observed in type or incidence of serious adverse events.

About Locally Advanced Pancreatic Cancer (LAPC)

Pancreatic cancer arises when cells in the pancreas, a glandular organ behind the stomach, begin to multiply out of control and form a mass. These cancerous cells have the ability to invade other parts of the body. There are several types of pancreatic cancer. In locally advanced pancreatic cancer, the patient's tumor typically involves structures, particularly blood vessels that are closely associated with the pancreas such as the superior mesenteric artery and superior mesenteric vein. Involvement of the cancer around these blood vessels precludes surgical removal of the tumor.

About Pamrevlumab

Pamrevlumab is a first-in-class antibody developed by FibroGen to inhibit the activity of connective tissue growth factor (CTGF), a common factor in fibrotic and proliferative disorders. Fibrosis is characterized by persistent and excessive scarring that can lead to organ dysfunction and failure. In desmoplastic, or fibrotic cancers, fibrous tissue promotes abnormal proliferation of tumor cells and associated stromal cells. Pamrevlumab is advancing towards Phase-3 clinical development for the treatment of idiopathic pulmonary fibrosis (IPF) and pancreatic cancer and is currently in a Phase-2 trial for Duchenne muscular dystrophy (DMD).

About FibroGen, Inc.

Founded in 1993, FibroGen is a leading science-based biopharmaceutical company discovering and developing a pipeline of first-in-class therapeutics. The company applies its pioneering expertise in fibrosis and hypoxia-inducible factor (HIF) biology and clinical development to advance innovative medicines for the treatment of anemia, fibrotic disease, and cancer. Headquartered in San Francisco, California, FibroGen has subsidiary offices in Beijing and Shanghai, China.

Stock Performance Snapshot

March 02, 2018 - At Friday's closing bell, FibroGen's stock slightly climbed 0.82%, ending the trading session at $55.40.

Volume traded for the day: 730.96 thousand shares, which was above the 3-month average volume of 637.49 thousand shares.

Stock performance in the last three-month - up 18.00%; previous six-month period - up 19.27%; past twelve-month period - up 119.84%; and year-to-date - up 16.88%

After last Friday's close, FibroGen's market cap was at $4.54 billion.

The stock is part of the Healthcare sector, categorized under the Biotechnology industry. This sector was up 1.2% at the end of the session.

Active-Investors:

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The non-sponsored content contained herein has been prepared by a writer (the "Author") and is fact checked and reviewed by a third-party research service company (the "Reviewer") represented by a credentialed financial analyst [for further information on analyst credentials, please email info@active-investors.com. Rohit Tuli, a CFA® charterholder (the "Sponsor"), provides necessary guidance in preparing the document templates. The Reviewer has reviewed and revised the content, as necessary, based on publicly available information which is believed to be reliable. Content is researched, written and reviewed on a reasonable effort basis. The Reviewer has not performed any independent investigations or forensic audits to validate the information herein. The Reviewer has only independently reviewed the information provided by the Author according to the procedures outlined by A-I. A-I is not entitled to veto or interfere in the application of such procedures by the third-party research service company to the articles, documents or reports, as the case may be. Unless otherwise noted, any content outside of this document has no association with the Author or the Reviewer in any way.

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