FibroGen Announces Retirement of K. Peony Yu, M.D., and Appointment of Mark Eisner, M.D., M.P.H. as Chief Medical Officer
FibroGen, Inc. (NASDAQ: FGEN) has announced the retirement of Dr. K. Peony Yu as Chief Medical Officer, effective December 20, 2020, just ahead of the PDUFA date for roxadustat. Dr. Yu will assist in the transition as Executive Advisor to the CEO until March 15, 2021. Mark Eisner, with over 30 years of experience, will step in as the new Chief Medical Officer on December 21, 2020, overseeing global clinical development. This leadership change comes as the company aims to accelerate its development pipeline and achieve significant clinical milestones.
- Appointment of Mark Eisner as CMO expected to bring fresh perspectives and extensive expertise in clinical development.
- Dr. Eisner's background may enhance the company's ability to advance its clinical pipeline, especially with ongoing studies for roxadustat.
- Retirement of Dr. Peony Yu may raise concerns over continuity in leadership during a critical phase for the company.
SAN FRANCISCO, Dec. 01, 2020 (GLOBE NEWSWIRE) -- FibroGen, Inc. (NASDAQ: FGEN) today announced the retirement of K. Peony Yu, M.D., Chief Medical Officer, and appointment of Mark Eisner, M.D., M.P.H. in that role. Dr. Yu will continue as Chief Medical Officer through December 20, 2020, the roxadustat PDUFA date, and will remain with FibroGen through March 15, 2021 serving as Executive Advisor to the CEO to support the transition.
Dr. Yu joined FibroGen in 2008 and has provided key leadership for global clinical development across the company, leading the development of roxadustat in multiple indications and advancement of the overall portfolio.
“On behalf of the board, shareholders, and our employees, I want to thank Peony for her tremendous contributions as Chief Medical Officer of FibroGen,” said Enrique Conterno, Chief Executive Officer, FibroGen. “With her considerable expertise and leadership, roxadustat was approved in China and Japan for the treatment of CKD anemia with pending regulatory decisions in the US, EU, and additional countries, to potentially serve millions of patients worldwide.”
“It has been my privilege to work with many talented colleagues at FibroGen to make a difference in the lives of many," said Dr. Yu. "I look forward to our upcoming roxadustat U.S. PDUFA date, and expect FibroGen will continue to advance important new medicines.”
Mark Eisner, M.D., M.P.H. has joined FibroGen as of today, and will become Chief Medical Officer effective December 21, 2020, overseeing all global clinical development and regulatory affairs for FibroGen. Dr. Eisner has nearly 30 years of academic, biopharmaceutical, and drug development experience, from early clinical phase through post-commercialization.
“Mark’s extensive leadership, clinical development, and regulatory expertise come at a critical time for the company as we accelerate our development and look ahead to multiple significant clinical milestones. The depth and breadth of his therapeutic development experience is an ideal fit, and we are thrilled to welcome him to the FibroGen team,” said Enrique Conterno, Chief Executive Officer, FibroGen. “We look forward to Mark’s contributions as a proven business leader, clinician, and researcher in our continued evolution toward becoming a commercial-stage biopharmaceutical company with a maturing clinical pipeline.”
“I am excited to lead the clinical development organization during this important time at FibroGen, when the company is rapidly advancing its robust late-stage pipeline,” said Dr. Eisner. “I look forward to progressing the current clinical studies to bring valuable medicines to patients."
Dr. Eisner, who brings more than 10 years of experience in clinical drug development and 20 years as a practicing physician, has held leadership positions in academic medicine, clinical research, and pharmaceutical development. In 2010, he joined Genentech, a member of the Roche Group, and was most recently Senior Vice President and Global Head of Product Development Immunology, Infectious Disease, and Ophthalmology where he led clinical development for areas including respiratory medicine, rheumatology, nephrology, inflammatory bowel disease, virology, and retinal disease.
Prior to Genentech, Mark was Professor of Medicine and Anesthesia at the University of California San Francisco where he was an internationally recognized expert on clinical research in acute and chronic lung disease. He served as a steering committee member and ultimately UCSF Principal Investigator for the National Heart, Lung, and Blood Institute ARDS Clinical Trials Network which conducted several clinical landmark trials. Mark also built a world-class NIH-funded clinical research program focusing on the epidemiology and long-term health outcomes of obstructive lung disease. He was also an investigator in the UCSF Cardiovascular Research Institute. Mark published ~200 peer-reviewed articles, served on multiple NIH study sections, and was a member of the American Thoracic Society Board of Directors.
Mark graduated from Stanford University with an A.B. degree in Human Biology and then received his M.D. degree from the University of Pennsylvania School of Medicine. He completed residency training in internal medicine, served as Chief Medical Resident, and pursued advanced fellowship training in pulmonary and critical care medicine at the University of California, San Francisco. He also received a M.P.H. degree from the University of California, Berkeley School of Public Health.
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 idiopathic pulmonary fibrosis (IPF), locally advanced unresectable pancreatic cancer (LAPC), Duchenne muscular dystrophy (DMD), and coronavirus (COVID-19). 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, our clinical programs and regulatory events and those of our partners, and the commercial prospects of roxadustat. 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, 2019 and our Quarterly Report on Form 10-Q for quarter ended September 30, 2020 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.
Investor Relations
+1.415.978.1434
mtung@fibrogen.com
Media:
Jennifer Harrington
+1.610.574.9196
Jennifer.Harrington@gcihealth.com
FAQ
Who has been appointed as the new Chief Medical Officer of FibroGen?
What will Dr. K. Peony Yu's role be after her retirement from FibroGen?
Why is the appointment of Mark Eisner significant for FibroGen?
When is the PDUFA date for roxadustat?
