Intercept to Provide Update on Phase 3 REGENERATE Trial of Obeticholic Acid for the Treatment of NASH Patients with Liver Fib...
February 10 2017 - 7:00AM
Intercept Pharmaceuticals, Inc. (Nasdaq:ICPT) (Intercept), a
biopharmaceutical company focused on the development and
commercialization of novel therapeutics to treat progressive
non-viral liver diseases, will provide an update on the Phase 3
REGENERATE trial of obeticholic acid (OCA) in NASH patients with
liver fibrosis during a conference call today, Friday February 10
at 8:30 a.m. ET.
The live event will be available on the investor page of the
Intercept website at http://ir.interceptpharma.com or by calling
(855) 232-3919 (toll-free domestic) or (315) 625-6894
(international) five minutes prior to the start time (no passcode
is required). A replay of the call will be available on the
Intercept website approximately two hours after the completion of
the call and will be archived for two weeks.
About Nonalcoholic SteatohepatitisNASH is a
serious progressive liver disease caused by excessive fat
accumulation in the liver that induces chronic inflammation,
resulting in progressive fibrosis (scarring) that can lead to
cirrhosis, eventual liver failure, cancer and death. There are
currently no medications approved for the treatment of NASH. The
proportion of liver transplants attributable to NASH has increased
rapidly in past years and by 2020 the disease is projected to
become the leading indication for liver transplant.
About the Phase 3 REGENERATE TrialREGENERATE is
Intercept’s ongoing international Phase 3 trial studying OCA in
NASH patients with liver fibrosis. REGENERATE is expected to enroll
approximately 2,000 patients at approximately 350 qualified centers
worldwide. The U.S. Food and Drug Administration (FDA) has
designated OCA as a breakthrough therapy in NASH patients with
fibrosis and REGENERATE was designed in accordance with advice from
the FDA and European Medicines Agency (EMA).
About InterceptIntercept is a biopharmaceutical
company focused on the development and commercialization of novel
therapeutics to treat progressive non-viral liver diseases,
including primary biliary cholangitis (PBC), nonalcoholic
steatohepatitis (NASH), primary sclerosing cholangitis (PSC) and
biliary atresia. Founded in 2002 in New York, Intercept now has
operations in the United States, Europe and Canada. For more
information about Intercept, please visit www.interceptpharma.com.
Safe Harbor Statements This press release
contains "forward-looking statements" within the meaning of the
Private Securities Litigation Reform Act of 1995, including, but
not limited to, statements regarding the continued development of
OCA and Intercept's other product candidates in NASH and other
indications and timelines related thereto, and our strategic
directives under the caption "About Intercept." These
"forward-looking statements" are based on management's current
expectations of future events and are subject to a number of
important risks and uncertainties that could cause actual results
to differ materially and adversely from those set forth in or
implied by such forward-looking statements. These risks and
uncertainties include, but are not limited to: Intercept's ability
to successfully commercialize Ocaliva in PBC, and Intercept's
ability to maintain its regulatory approval in jurisdictions in
which Ocaliva is approved for use in PBC; the initiation, cost,
timing, progress and results of Intercept's development activities,
preclinical studies and clinical trials, including Intercept’s
development program in NASH; the timing of and Intercept's ability
to obtain and maintain regulatory approval of OCA in PBC in
countries outside the ones in which it is approved and in
indications other than PBC and any other product candidates it may
develop such as INT-767; conditions that may be imposed by
regulatory authorities on Intercept's marketing approvals for its
product candidates such as the need for clinical outcomes data (and
not just results based on achievement of a surrogate endpoint), and
any related restrictions, limitations, and/or warnings in the label
of any approved product candidates; Intercept's plans to research,
develop and commercialize its product candidates; Intercept's
ability to obtain and maintain intellectual property protection for
its product candidates; Intercept's ability to successfully
commercialize OCA in indications other than PBC and its other
product candidates; the size and growth of the markets for
Intercept's product candidates and its ability to serve those
markets; the rate and degree of market acceptance of any of
Intercept's products, which may be affected by the reimbursement
that it may receive for its products from payors; the success of
competing drugs that are or become available; the election by
Intercept's collaborators to pursue research, development and
commercialization activities; Intercept's ability to attract
collaborators with development, regulatory and commercialization
expertise; regulatory developments in the United States and other
countries; the performance of third-party suppliers and
manufacturers; Intercept's need for and ability to obtain
additional financing; Intercept's estimates regarding expenses,
future revenues and capital requirements and the accuracy thereof;
Intercept's use of cash, short-term investments and the proceeds
from the offering; Intercept's ability to attract and retain key
scientific or management personnel; and other factors discussed
under the heading "Risk Factors" contained in our annual report on
Form 10-K for the year ended December 31, 2015 filed on February
29, 2016 as well as any updates to these risk factors filed from
time to time in our other filings with the Securities and Exchange
Commission. All information in this press release is as of the date
of the release, and Intercept undertakes no duty to update this
information unless required by law.
Contact
For more information about Intercept Pharmaceuticals, please contact:
Mark Vignola
+1-646-747-1000
investors@interceptpharma.com
Christopher Frates
+1-646-757-2371
media@interceptpharma.com
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