$ICPT News

Last published 2y ago

2y agoICPTIntercept Announces New PBC Data Analyses to be Presented at Digestive Disease Week® 2024 ConferenceGlobeNewswireMORRISTOWN, N.J., May 09, 2024 (GLOBE NEWSWIRE) -- Intercept Pharmaceuticals, Inc., a biopharmaceutical company and wholly owned subsidiary of Alfasigma S.p.A. focused on the development and commercialization of novel
2y agoICPTIntercept Announces FDA Acceptance of Supplemental New Drug Application for Ocaliva® (obeticholic acid) for the Treatment of PBCGlobeNewswiresNDA intended to satisfy post-marketing requirements to confirm a clinical benefit in patients with PBCPrecedent-setting submission includes data from post-marketing studies COBALT and Study 401 as well as real-world
2y agoICPTIntercept Announces New Phase 2 Data Showing Significant Impact of OCA-Bezafibrate Combination on Normalization of Multiple Key Biomarkers of PBC-Induced Liver Damage at AASLD The Liver Meeting® 2023GlobeNewswireData from two Phase 2 studies in PBC show combination of OCA + bezafibrate achieved biochemical remission (normalization of ALP, total bilirubin, GGT, ALT and AST) in 40-44% of patients in the first 12 weeks OCA 5 or
3y agoICPTIntercept Announces New Findings from Long-term Extension of Landmark POISE Trial in PBC Showing Importance of Biomarkers Beyond ALP at AASLD The Liver Meeting® 2023GlobeNewswireNew analysis demonstrates the impact of OCA on achievement of GGT <3.2×ULN and ALP <1.5×ULN Findings suggest that OCA has the potential to reduce the liver biomarker GGT, in addition to well-known effects on ALP,
3y agoICPTAlfasigma completes acquisition of Intercept Pharmaceuticals, Inc.GlobeNewswireBOLOGNA, Italy and MORRISTOWN, N.J., Nov. 08, 2023 (GLOBE NEWSWIRE) -- Alfasigma S.p.A. ("Alfasigma") and Intercept Pharmaceuticals, Inc. ("Intercept") announced today the completion of the acquisition of Intercept by
3y agoICPTAlfasigma S.p.A. successfully completes tender offer for all outstanding shares of common stock of Intercept Pharmaceuticals, Inc.Business WireAlfasigma S.p.A. ("Alfasigma") announced today that it has, through its wholly owned subsidiary Interstellar Acquisition Inc. ("Interstellar"), successfully completed its tender offer to purchase all outstanding shares
3y agoICPTStudy to Assess Efficacy, Safety, Tolerability, Pharmacokinetics (PK), and Pharmacodynamics (PD) of Obeticholic Acid (OCA) Compared to Placebo in Pediatric Participants With Biliary Atresia, Post-hepatoportoenterostomy - NCT06121375ClinicalTrials.govTime to the First Occurrence of Composite Endpoint, Plasma concentration of unconjugated OCA (parent), glyco-OCA, tauro-OCA, and total OCA (molar sum of OCA and its active conjugates), Change from Baseline in Gamma Glutamyl Transferase (GGT), (and 7 more...)
3y agoICPTAlfasigma S.p.A. Announces Expiration of Hart-Scott-Rodino Waiting Period in Connection with Pending Acquisition of Intercept Pharmaceuticals, Inc.Business WireAlfasigma S.p.A. ("Alfasigma") today announced that the required waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976 (the "HSR Act") with respect to Alfasigma's proposed acquisition of
3y agoCSTL EQ ICPTPersephone Biosciences Appoints Daniel Bradbury as Chair of the Board of DirectorsBusiness Wire-Mr. Bradbury has over 35 years of experience leading fast-growing life sciences companies- Persephone Biosciences Inc., a biotechnology company reimagining patient health through the development of microbiome-based
3y agoICPT SRT PCTI SPMoore Kuehn Encourages ICPT, SRT, PCTI, and SP Investors to Contact Law FirmPR NewswireMoore Kuehn, PLLC, a law firm focusing in securities litigation located on Wall Street in downtown New York City, is investigating potential claims...
3y agoICPTAlfasigma S.p.A. Tender Offer for Intercept Pharmaceuticals, Inc. CommencesBusiness WireAlfasigma S.p.A. ("Alfasigma") today announced that its wholly-owned subsidiary, Interstellar Acquisition Inc., a Delaware corporation ("Purchaser"), has commenced a cash tender offer to purchase all of the outstanding
3y agoAMTI CHS ICPT SPLKMoore Kuehn Encourages AMTI, SPLK, ICPT, and CHS Investors to Contact Law FirmPR NewswireNEW YORK, Oct. 4, 2023 /PRNewswire/ -- Moore Kuehn, PLLC, a law firm focusing in securities litigation located on Wall Street in downtown New York City, is investigating potential claims concerning whether the following
3y agoICPTICPT Alert: Monsey Firm of Wohl & Fruchter Investigating Fairness of the Proposed Sale of Intercept Pharmaceuticals to AlfasigmaGlobeNewswireMONSEY, N.Y., Sept. 26, 2023 (GLOBE NEWSWIRE) -- The law firm of Wohl & Fruchter LLP is investigating the fairness of the proposed sale of Intercept Pharmaceuticals, Inc. (NASDAQ:ICPT) ("Intercept") to Alfasigma
3y agoICPTAlfasigma to Acquire Intercept Pharmaceuticals for $19.00 per Share in Cash, Expanding the Global Footprint of Alfasigma Via a Leader in Rare and Serious Liver DiseasesGlobeNewswireProposed all-cash acquisition will materially expand Alfasigma's portfolio in gastroenterology and hepatology and its presence in the U.S. marketTransaction price represents an 82% premium to Intercept's closing price on
3y agoICPTIntercept Pharmaceuticals to Conduct Fireside Chats and One-on-One Meetings at Upcoming Investor ConferencesGlobeNewswireMORRISTOWN, N.J., Sept. 05, 2023 (GLOBE NEWSWIRE) -- Intercept Pharmaceuticals, Inc. (NASDAQ:ICPT), a biopharmaceutical company focused on the development and commercialization of novel therapeutics to treat rare and
3y agoICPTIntercept Pharmaceuticals, Inc. (ICPT) Q2 2023 Earnings Call TranscriptEarnings Call Transcripts
3y agoICPTIntercept Pharmaceuticals Reports Second Quarter 2023 Financial Results and Provides Business UpdatesGlobeNewswireOcaliva® (obeticholic acid or OCA) net sales of $83.7 million, representing 17% growth over the prior year quarterCompany updates full-year 2023 Ocaliva net sales guidance to $320 million to $340 million; reiterates
3y agoICPTIntercept to Announce Second Quarter 2023 Financial Results on August 2, 2023GlobeNewswireMORRISTOWN, N.J., July 26, 2023 (GLOBE NEWSWIRE) -- Intercept Pharmaceuticals, Inc. (NASDAQ:ICPT), a biopharmaceutical company focused on the development and commercialization of novel therapeutics to treat rare and
3y agoABEO ALLR ATXI ICPTAllarity Therapeutics Strengthens Board of Directors with Appointment of Three Accomplished Biotechnology ExecutivesGlobeNewswireNew appointments bring therapeutic development expertise and proven leadership to support continued progress of Allarity's multiple oncology clinical programs BOSTON (July 24, 2023) — Allarity Therapeutics, Inc.
3y agoICPTIntercept Announces Restructuring to Strengthen Focus on Rare and Serious Liver Diseases and Significantly Reduce Operating ExpensesGlobeNewswireMeasures reinforce Company's ability to drive growth in PBC business and continue developing innovative new medicines Company to discontinue all NASH-related investment and reduce workforce by approximately one third
3y agoICPTIntercept Presents New Data Showing Significant Impact of OCA-bezafibrate Combination on Normalization of Multiple Biomarkers of PBC-Induced Liver DamageGlobeNewswirePlanned interim analysis from the first of two Phase 2 studies shows combination of OCA 5-10 mg + bezafibrate 400 mg normalized a range of biomarkers of PBC (ALP, total bilirubin, GGT, ALT and AST) in 58% of patients at
3y agoICPTIntercept Receives Complete Response Letter from FDA for Obeticholic Acid as a Treatment for Pre-Cirrhotic Fibrosis due to NASHGlobeNewswireCompany to discontinue all NASH-related investment and restructure the Company's operations to strengthen its focus on rare and serious liver diseasesCompany anticipates achieving profitability in 2024 as a result of
3y agoICPTIntercept Announces New Data Showing Potential of Fixed-Dose Combination of OCA and Bezafibrate to Normalize Multiple Biomarkers in PBC to be Featured in Podium Presentation at EASL Congress 2023GlobeNewswireInterim analysis of ongoing Phase 2 study shows combination of OCA 5-10 mg + bezafibrate 400 mg improved levels of multiple biochemical markers associated with clinical outcomes in PBC including ALP, total bilirubin,
3y agoICPTIntercept Pharmaceuticals to Conduct One-on-One Meetings with Investors at the Jefferies Healthcare Conference June 7-8, 2023GlobeNewswireMORRISTOWN, N.J., May 31, 2023 (GLOBE NEWSWIRE) -- Intercept Pharmaceuticals, Inc. (NASDAQ:ICPT), a biopharmaceutical company focused on the development and commercialization of novel therapeutics to treat progressive
3y agoICPTKaplan Fox Investigates Intercept Pharmaceuticals, Inc. (NASDAQ: ICPT)GlobeNewswireNEW YORK, May 22, 2023 (GLOBE NEWSWIRE) -- Kaplan Fox & Kilsheimer LLP (www.kaplanfox.com) is investigating potential claims on behalf of investors who purchased Intercept Pharmaceuticals, Inc. (NASDAQ:ICPT)
3y agoICPTIntercept Announces Outcome of FDA Advisory Committee Meeting for Obeticholic Acid as a Treatment for Pre-Cirrhotic Fibrosis due to NASHGlobeNewswire12 of 16 voting-eligible advisors vote "no" (with two abstentions) on question, "given the available efficacy and safety data, do the benefits of OCA 25 mg outweigh the risks in NASH patients with stage 2 or 3 fibrosis?"
3y agoICPTIntercept Pharmaceuticals Stock Trading Halted Today; FDA Advisory Committee to Review Obeticholic Acid as a Treatment for Pre-Cirrhotic Fibrosis due to NASHGlobeNewswireMORRISTOWN, N.J., May 19, 2023 (GLOBE NEWSWIRE) -- Intercept Pharmaceuticals, Inc. (NASDAQ:ICPT), a biopharmaceutical company focused on the development and commercialization of novel therapeutics to treat progressive
3y agoICPTIntercept Pharmaceuticals Receives FDA Orphan Drug Designation for the Fixed-Dose Combination of OCA and Bezafibrate for the Treatment of Primary Biliary Cholangitis (PBC)GlobeNewswireCompany on track to complete planned interim analyses from two ongoing Phase 2 studies of the OCA-bezafibrate combination in 2023 Results from planned interim analysis of Phase 2 study evaluating the effects of OCA and
3y agoICPTIntercept Pharmaceuticals Reports First Quarter 2023 Financial Results and Provides Update on Commercial Launch Strategy for NASHGlobeNewswireOcaliva® net sales of $68.0 million, representing 15% growth over the prior year quarter Gastrointestinal Drugs Advisory Committee (GIDAC) Meeting set for May 19, 2023, to review obeticholic acid (OCA) as a
3y agoICPTIntercept Announces New Data to be Presented at The European Association for the Study of the Liver (EASL) Congress 2023 and Provides Update on OCA-bezafibrate Fixed-Dose Combination (FDC) Development ProgramGlobeNewswireSeven abstracts in primary biliary cholangitis (PBC) and nonalcoholic steatohepatitis (NASH) accepted at EASL 2023 Accepted abstracts include podium presentation of new data from the planned interim analysis of a Phase
3y agoICPTIntercept to Announce First Quarter 2023 Financial Results and Provide Update on Commercial Launch Strategy for NASH on April 27, 2023GlobeNewswireMORRISTOWN, N.J., April 13, 2023 (GLOBE NEWSWIRE) -- Intercept Pharmaceuticals, Inc. (NASDAQ:ICPT), a biopharmaceutical company focused on the development and commercialization of novel therapeutics to treat
3y agoICPTIntercept Announces FDA Advisory Committee Meeting Date for Obeticholic Acid as a Treatment for Pre-Cirrhotic Liver Fibrosis due to NASHGlobeNewswireAdvisory Committee Meeting scheduled for May 19, 2023 PDUFA Target Action Date is June 22, 2023 MORRISTOWN, N.J., March 10, 2023 (GLOBE NEWSWIRE) -- Intercept Pharmaceuticals, Inc. (NASDAQ:ICPT), a biopharmaceutical
3y agoICPTIntercept Pharmaceuticals to Conduct One-on-One Meetings with Investors at the Barclays Global Healthcare Conference March 14, 2023GlobeNewswireMORRISTOWN, N.J., March 09, 2023 (GLOBE NEWSWIRE) -- Intercept Pharmaceuticals, Inc. (NASDAQ:ICPT), a biopharmaceutical company focused on the development and commercialization of novel therapeutics to treat
3y agoICPTIntercept Pharmaceuticals Reports Fourth Quarter and Full Year 2022 Financial Results and Provides Business Updates; Issues 2023 Financial GuidanceGlobeNewswireU.S. Ocaliva® net sales of $77.2 million and $285.7 million for the fourth quarter and full year 2022, representing 13% and 10% growth over the prior year Worldwide Ocaliva® non-GAAP adjusted net sales of
3y agoICPTIntercept Pharmaceuticals to Participate in Cowen's 43rd Annual Health Care Conference on March 7, 2023GlobeNewswireMORRISTOWN, N.J., Feb. 27, 2023 (GLOBE NEWSWIRE) -- Intercept Pharmaceuticals, Inc. (NASDAQ:ICPT), a biopharmaceutical company focused on the development and commercialization of novel therapeutics to treat progressive
3y agoICPTIntercept to Announce Fourth Quarter and Full Year 2022 Financial Results on March 2, 2023GlobeNewswireMORRISTOWN, N.J., Feb. 23, 2023 (GLOBE NEWSWIRE) -- Intercept Pharmaceuticals, Inc. (NASDAQ:ICPT), a biopharmaceutical company focused on the development and commercialization of novel therapeutics to treat progressive
3y agoICPTFDA Accepts Intercept's New Drug Application for OCA for the Treatment of Pre-Cirrhotic Liver Fibrosis Due to NASHGlobeNewswireNDA is supported by robust NASH clinical development program, including two positive interim analyses from the Phase 3 REGENERATE study demonstrating OCA's improvement in liver fibrosis without worsening of NASHPDUFA
3y agoICPTIntercept Pharmaceuticals to Present at J.P. Morgan 41st Annual Healthcare Conference on January 12, 2023GlobeNewswireMORRISTOWN, N.J., Jan. 05, 2023 (GLOBE NEWSWIRE) -- Intercept Pharmaceuticals, Inc. (NASDAQ:ICPT), a biopharmaceutical company focused on the development and commercialization of novel therapeutics to treat progressive
3y agoICPTIntercept Announces Efficacy and Safety Data from Phase 3 REGENERATE Study in Liver Fibrosis due to NASH to be Presented at NASH-TAG Conference 2023GlobeNewswireMORRISTOWN, N.J., Jan. 04, 2023 (GLOBE NEWSWIRE) -- Intercept Pharmaceuticals, Inc. (NASDAQ:ICPT), a biopharmaceutical company focused on the development and commercialization of novel therapeutics to treat progressive
3y agoICPTIntercept Resubmits New Drug Application to U.S. FDA for Obeticholic Acid in Patients with Liver Fibrosis due to NASHGlobeNewswireNDA supported by robust NASH clinical development program, including two positive interim analyses from the Phase 3 REGENERATE study NDA includes detailed safety analysis of 2,477 patients with nearly 1,000 patients
3y agoICPTNew Study Published in The American Journal of Pathology Suggests Obeticholic Acid (OCA) May Improve Cognitive Impairment Associated with Cholestatic Liver DiseaseGlobeNewswireMORRISTOWN, N.J., Dec. 08, 2022 (GLOBE NEWSWIRE) -- Intercept Pharmaceuticals, Inc. (NASDAQ:ICPT), a biopharmaceutical company focused on the development and commercialization of novel therapeutics to treat progressive
3y agoICPTFXR Effect on Severe Alcohol-Associated Hepatitis (FRESH) Study - NCT05639543ClinicalTrials.govDifference in Lille score response by treatment group, Change from baseline in MELD-Na at 28-days by treatment group, Difference in 28-day, 56-day, and 84-day mortality or liver transplantation between INT-787 and placebo, (and 6 more...)
3y agoICPTIntercept Pharmaceuticals to Participate in Piper Sandler's 34th Annual Healthcare Conference on December 1, 2022GlobeNewswireMORRISTOWN, N.J., Nov. 22, 2022 (GLOBE NEWSWIRE) -- Intercept Pharmaceuticals, Inc. (NASDAQ:ICPT), a biopharmaceutical company focused on the development and commercialization of novel therapeutics to treat progressive
4y agoICPTKomodo Health's Real-World Evidence and Technology Platform Powers Two Real-World Analyses in Primary Biliary Cholangitis for Intercept PharmaceuticalsBusiness WireToday, Komodo Health announced a collaboration with Intercept Pharmaceuticals (NASDAQ:ICPT), powering clinical research and new real-world evidence with Komodo's platform. Intercept leveraged Komodo's technology to fuel
4y agoICPTIntercept Announces Development Program for Next-Generation FXR Agonist INT-787 in Severe Alcohol-Associated HepatitisGlobeNewswireFirst-in-human data shared at The Liver Meeting® 2022 supported a favorable safety and tolerability profile for INT-787 in healthy adults Company announces severe alcohol-associated hepatitis (sAH), a disease with
4y agoICPTIntercept Announces Additional Positive Data in Fibrosis due to NASH from New Analysis of Phase 3 REGENERATE Study at AASLD The Liver Meeting® 2022GlobeNewswireOCA 25 mg demonstrated double the response rate of placebo in reduction of liver fibrosis without worsening of NASH; consistent antifibrotic effect shown across multiple analyses OCA 25 mg showed increased antifibrotic
4y agoICPTIntercept Announces Two Analyses Demonstrating Improvement in Outcomes, Including Transplant-Free Survival, for PBC Patients Treated with OCA to be Presented at AASLD The Liver Meeting® 2022GlobeNewswireEfficacy of OCA vs. placebo and external controls accepted as a late-breaker poster HEROES-US data to be presented in oral session on Sunday, November 6 MORRISTOWN, N.J., Nov. 06, 2022 (GLOBE NEWSWIRE) -- Intercept
4y agoICPTIntercept Pharmaceuticals Reports Third Quarter 2022 Financial Results and Provides Business UpdateGlobeNewswireU.S. Ocaliva® net sales of $77.6 million; 16.4% growth over the prior year quarter Company increases 2022 Ocaliva non-GAAP adjusted net sales guidance to $340 million to $350 million and narrows non-GAAP adjusted
4y agoICPTIntercept Announces New Data to be Presented in PBC, Liver Fibrosis due to NASH and Pipeline at AASLD The Liver Meeting® 2022GlobeNewswireData from Phase 3 REGENERATE study supporting positive benefit-risk profile of obeticholic acid (OCA) in liver fibrosis due to NASH to be featured in late-breaker podium presentation Analysis demonstrating improvement
4y agoICPTIntercept to Announce Third Quarter 2022 Financial Results on November 1, 2022GlobeNewswireMORRISTOWN, N.J., Oct. 25, 2022 (GLOBE NEWSWIRE) -- Intercept Pharmaceuticals, Inc. (NASDAQ:ICPT), a biopharmaceutical company focused on the development and commercialization of novel therapeutics to treat progressive