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 FibroGenFibroGen, 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 StatementsThis 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+1.415.978.1434mtung@fibrogen.com
Media:Jennifer
Harrington+1.610.574.9196Jennifer.Harrington@gcihealth.com
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