Welcome to our dedicated page for Intercept Pharmaceuticals news (Ticker: ICPT), a resource for investors and traders seeking the latest updates and insights on Intercept Pharmaceuticals stock.
Intercept Pharmaceuticals, Inc. (ICPT) is a leading biopharmaceutical company dedicated to the development and commercialization of innovative therapeutics aimed at treating progressive, non-viral liver diseases. Intercept's core focus is primarily on conditions such as primary biliary cholangitis (PBC), nonalcoholic steatohepatitis (NASH), primary sclerosing cholangitis (PSC), and biliary atresia. With its headquarters in New York and additional offices in San Diego, London, and Perugia, Intercept is well-positioned globally to drive forward its ambitious healthcare initiatives.
The company's flagship product, Ocaliva® (obeticholic acid), is a farnesoid X receptor (FXR) agonist, approved for the treatment of adults with PBC, either in combination with ursodeoxycholic acid (UDCA) for those with an inadequate response to UDCA or as monotherapy for patients who cannot tolerate UDCA. The recent developments include a landmark Phase 3 POISE trial revealing significant impacts on key biomarkers for PBC treatment, demonstrating Ocaliva's potential to not only reduce gamma-glutamyl transferase (GGT) and alkaline phosphatase (ALP) levels but also improve clinical outcomes.
In addition, Intercept is actively engaged in advancing the investigational combination of OCA and bezafibrate, shown in Phase 2 studies to affect multiple key serum biomarkers predictive of clinical outcomes. This combination therapy targets both FXR and peroxisome proliferator-activated receptor (PPAR) pathways, offering potential enhanced therapeutic benefits.
Financially stable, Intercept continues to invest significantly in R&D, highlighted by recent presentations at the American Association for the Study of Liver Diseases (AASLD) and Digestive Disease Week® (DDW). As of February 2024, the FDA has accepted a supplemental New Drug Application (sNDA) for Ocaliva, further solidifying its position in the liver disease treatment market. Intercept remains committed to improving patient outcomes and enhancing the quality of life for those affected by these serious conditions.
For the most current news and developments, visit the Intercept Pharmaceuticals website or follow their updates on LinkedIn and Twitter.
Intercept Pharmaceuticals (Nasdaq: ICPT) will announce its fourth quarter and full year 2020 financial results on February 25, 2021, before market opening. The announcement will be followed by a conference call at 8:30 a.m. ET, where management will discuss the results. The conference call can be accessed via the investor website or through dedicated phone lines for domestic and international callers. Intercept focuses on therapeutics for progressive non-viral liver diseases such as primary biliary cholangitis and nonalcoholic steatohepatitis.
Intercept Pharmaceuticals (Nasdaq:ICPT) announced that an analyst's note on the FDA Adverse Event Reporting System regarding a newly identified safety signal (NISS) for Ocaliva® (obeticholic acid) was deemed incorrect by the company. Intercept emphasizes that the absence of a listed medicine in the FDA's updates does not indicate the completion of its evaluation. Ongoing discussions with the FDA aim to clarify the NISS, which is classified as a potential risk but does not imply a causal relationship with Ocaliva. The FDA's review focuses on advanced Primary Biliary Cholangitis patients taking Ocaliva.
Intercept Pharmaceuticals has appointed Jared M. Freedberg as General Counsel and Secretary. Freedberg, formerly of Immunomedics, brings extensive legal and business development experience. His role is critical as the company aims to enhance its primary biliary cholangitis (PBC) business and advance its nonalcoholic steatohepatitis (NASH) regulatory processes in the U.S. and Europe. The leadership change is part of Intercept's strategy to strengthen its pipeline and support ongoing clinical trials.
Intercept Pharmaceuticals (Nasdaq:ICPT) has announced that Jerry Durso, President and CEO, will present at the 39th Annual J.P. Morgan Virtual Healthcare Conference on January 14, 2021, at 11:40 a.m. ET. The event will be available via a live webcast on the investor page of Intercept’s website, with an audio archive accessible for two weeks following the event.
Intercept focuses on developing therapeutics for progressive non-viral liver diseases, including primary biliary cholangitis and nonalcoholic steatohepatitis.
Intercept Pharmaceuticals has announced the appointment of Jerome (Jerry) Durso as its new CEO, effective January 1, 2021. Durso, currently the Chief Operating Officer, will also join the Board of Directors. Founder and former CEO Mark Pruzanski will remain a board member and advisor. The leadership transition is expected to enhance the growth of Intercept's primary biliary cholangitis (PBC) business and support the regulatory process for nonalcoholic steatohepatitis (NASH) in the U.S. and Europe. Durso brings over 25 years of experience in life sciences.
Intercept Pharmaceuticals (Nasdaq:ICPT) announced its participation in the Piper Sandler 32nd Annual Virtual Healthcare Conference on December 1, 2020, from 3:30 to 3:55 p.m. ET. Key executives, including President and CEO Mark Pruzanski and CFO Sandip Kapadia, will engage in a fireside chat. A live webcast will be accessible on Intercept's investor page, with an audio archive available for two weeks post-event. Intercept focuses on novel therapeutics for progressive non-viral liver diseases, particularly primary biliary cholangitis and nonalcoholic steatohepatitis.
Intercept Pharmaceuticals has presented new analyses at The Liver Meeting Digital Experience, reinforcing the clinical value of noninvasive tests (NITs) for identifying and monitoring advanced fibrosis due to NASH. The analyses revealed that the treatment with obeticholic acid (OCA) achieved significant reductions in liver enzyme levels and stiffness compared to placebo. The REGENERATE Phase 3 study showed that OCA met its primary endpoint of fibrosis improvement with high statistical significance. Additional findings support that sequential NITs could reduce the need for liver biopsies.
Intercept Pharmaceuticals reported Ocaliva net sales of $79.5 million for Q3 2020, a 29% increase year-over-year. The company narrowed its 2020 net sales guidance for Ocaliva to $310 million to $320 million and adjusted operating expenses guidance to $460 million to $480 million. A constructive meeting with the FDA was held regarding the NASH fibrosis program, aiming for a potential NDA resubmission next year. The firm reported a net loss of $66.5 million, improving from $84.8 million the previous year. Cash and investments stood at approximately $496.8 million as of Q3 2020.
Intercept Pharmaceuticals (Nasdaq: ICPT) is set to release its Q3 2020 financial results on November 9, 2020, before the market opens. This announcement will be followed by a conference call at 8:30 a.m. ET to discuss the results in detail. Investors can access the conference through the company's investor webpage or via phone. Intercept focuses on developing treatments for progressive non-viral liver diseases, including primary biliary cholangitis (PBC) and nonalcoholic steatohepatitis (NASH), and has operations across North America and Europe.
Intercept Pharmaceuticals (Nasdaq: ICPT) announced that multiple abstracts related to obeticholic acid (OCA) for treating primary biliary cholangitis (PBC) and fibrosis due to non-alcoholic steatohepatitis (NASH) will be presented at The Liver Meeting Digital Experience™ from November 13-16, 2020. Significant findings will include long-term efficacy and safety data from the POISE trial and a post hoc analysis from the REGENERATE study, highlighting OCA's antifibrotic effects. The company's ongoing commitment to advancing treatment options for liver diseases is emphasized by these presentations.
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