ICPT - Earnings announcements

MORRISTOWN, 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 serious liver diseases, will announce its second quarter 2023 financial results on Wednesday, August 2, 2023. The announcement will be followed by a conference call and audio webcast at 8:30 a.m. ET. Participants can access the conference call live via webcast which will be available on the investor page of the company's website at http://ir.interceptpharma.com. Participants who wish to ask a question may register here to receive dial-in numbers and a unique pin to join the

Company 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 planned actionsConference call scheduled for Friday, June 23, 2023, at 8:30 a.m. ET MORRISTOWN, N.J., June 22, 2023 (GLOBE NEWSWIRE) -- Intercept Pharmaceuticals, Inc. (NASDAQ:ICPT), a biopharmaceutical company focused on the development and commercialization of novel therapeutics to treat rare and serious liver diseases, today announced that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) in response to the Company's New Drug Applicat

12 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?" 15 of 16 voting-eligible advisors vote to "defer approval until clinical outcome data from trial 747-303 are submitted and reviewed, at which time the traditional approval pathway could be considered" PDUFA Target Action Date set for June 22, 2023 Company to host conference call on Monday, May 22, 2023, at 8:30 a.m. ET MORRISTOWN, N.J., May 19, 2023 (GLOBE NEWSWIRE) -- Intercept Pharmaceuticals, Inc. (NASDAQ:ICPT), a biopharmaceutical company focused on the development

MORRISTOWN, 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 progressive non-viral liver diseases, will announce its first quarter 2023 financial results on Thursday, April 27, 2023, and provide an update on the commercial launch strategy for obeticholic acid (OCA) in nonalcoholic steatohepatitis (NASH). The announcement will be followed by a conference call and webcast presentation from 8:00 a.m. to 9:30 a.m. ET. The Company, which has filed a New Drug Application (NDA) seeking accelerated approval of OCA for the treatment of patients with pre

U.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 $343.8 million for the full year 2022 As of December 31, 2022, Company has cash, cash equivalents, restricted cash, and investment debt securities available for sale of $490.9 million PDUFA target action date set for June 22, 2023, for OCA for the treatment of pre-cirrhotic liver fibrosis due to NASH Company has fully resolved the patent infringement litigation that was scheduled for trial on February 27, 2023; settlements protect Ocaliva market exclusivity into the 2030s Company to h

MORRISTOWN, 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 non-viral liver diseases, will announce its fourth quarter and full-year 2022 financial results on Thursday, March 2, 2023. The announcement will be followed by a conference call and audio webcast at 8:30 a.m. ET.   Participants can access the conference call live via webcast which will be available on the investor page of the company's website at http://ir.interceptpharma.com. Participants who wish to ask a question may register here to receive dial-in numbers and a unique

U.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 operating expense guidance to $350 million to $365 million  As of September 30, 2022, Company has cash, cash equivalents, restricted cash, and investment debt securities available for sale of $497.8 million Company remains on track to resubmit new drug application (NDA) for obeticholic acid (OCA) in liver fibrosis due to NASH by end of 2022 based on the positive Phase 3 REGENERATE study MORRISTOWN, N.J., Nov. 01, 2022 (GLOBE NEWSWIRE) -- Intercept Pharmaceuticals, Inc. (NASDA

MORRISTOWN, 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 non-viral liver diseases, will announce its third quarter 2022 financial results prior to market open on Tuesday, November 1, 2022. The announcement will be followed by a conference call and audio webcast at 8:30 a.m. ET.  Participants can access the conference call live via webcast which will be available on the investor page of our website at http://ir.interceptpharma.com. Participants who wish to ask a question may register here to receive dial-in numbers and a unique pi

Worldwide Ocaliva® non-GAAP adjusted net sales in PBC of $100.4 million; U.S. net sales of $71.8 million representing 5% growth over the prior year quarter Company reissues 2022 financial guidance to reflect impact of sale of international business: Ocaliva non-GAAP adjusted net sales guidance of $325 million to $345 million and non-GAAP adjusted operating expense guidance of $335 million to $365 million Intercept completed the sale of its international business for $405 million in upfront consideration on July 1, 2022 Following pre-submission meeting with FDA, Company to resubmit new drug application (NDA) in liver

MORRISTOWN, N.J., July 27, 2022 (GLOBE NEWSWIRE) -- Intercept Pharmaceuticals, Inc. (NASDAQ:ICPT), a biopharmaceutical company focused on the development and commercialization of novel therapeutics to treat progressive non-viral liver diseases, will announce its second quarter 2022 financial results prior to market open on Wednesday, August 3, 2022. The announcement will be followed by a conference call and audio webcast hosted by Intercept management at 8:30 a.m. ET to discuss the results. Participants can access the conference call live via webcast which will be available on the investor page of our website at http://ir.interceptpharma.com. Participants who wish to ask a question may re

OCA 25 mg met the agreed primary endpoint of improvement in liver fibrosis without worsening of NASH at 18 months (p<0.0001), consistent with the original REGENERATE analysis OCA 25 mg demonstrated double the response rate in reduction of liver fibrosis without worsening of NASH vs. placebo Includes larger and more robust safety database of 2,477 patients with nearly 1,000 on study drug for 4 years Intercept to resubmit new drug application (NDA) in liver fibrosis due to NASH; pre-submission meeting with FDA scheduled later this month Company to host conference call at 8:30 a.m. ET today MORRISTOWN, N.J., July 07, 2022 (GLO

Worldwide Ocaliva® net sales of $88.6 million, representing 8% growth over the prior year quarter Nearing completion of new REGENERATE data analyses; planning for potential pre-submission meeting with FDA in June Continue to expect topline results from Phase 3 REVERSE study in compensated cirrhosis due to NASH in Q3 Advanz Pharma to acquire Ocaliva® (obeticholic acid) in PBC markets outside the U.S. for up to $450MM, including $405MM upfront and an additional $45MM in contingent payments Company to host conference call today at 8:30 a.m. ET MORRISTOWN, N.J, May 06, 2022 (GLOBE NEWSWIRE) -- Intercept Pharmaceuticals, Inc. (NASDAQ:ICPT), a biopharmaceutical company focused on the devel

Agreement includes rights for Advanz to commercialize orphan drug Ocaliva® for PBC outside the U.S., as well as the transition to Advanz of the international commercial and medical infrastructure of Intercept Additionally, Intercept will receive royalties on any future ex-U.S. net sales of obeticholic acid in NASH Intercept to discuss further details during Q1 2022 earnings call on Friday, May 6th at 8:30 a.m. ET MORRISTOWN, N.J., May 05, 2022 (GLOBE NEWSWIRE) -- Intercept Pharmaceuticals, Inc. (NASDAQ:ICPT), a biopharmaceutical company focused on the development and commercialization of novel therapeutics to treat progressive non-viral liver diseases, today announced it has entered i

MORRISTOWN, N.J., May 02, 2022 (GLOBE NEWSWIRE) -- Intercept Pharmaceuticals, Inc. (NASDAQ:ICPT), a biopharmaceutical company focused on the development and commercialization of novel therapeutics to treat progressive non-viral liver diseases, will announce its first quarter 2022 financial results prior to market open on Friday, May 6, 2022. The announcement will be followed by a conference call and audio webcast hosted by Intercept management at 8:30 a.m. ET to discuss the results. The conference call will be available on the investor page of our website at http://ir.interceptpharma.com or by calling (855) 232-3919 (toll-free) with passcode 7738727. Archived webcasts will be available on

Worldwide Ocaliva® net sales of $92.4 million and $363.5 million for the fourth quarter and full year 2021, representing 11% and 16% growth over the prior year Company provides 2022 Ocaliva net sales guidance of $375 million to $405 million and non-GAAP adjusted operating expense guidance of $360 million to $390 million Data package from REGENERATE Phase 3 study in fibrosis due to NASH being generated; targeting potential pre-submission meeting with FDA in 1H 2022 Topline results from REVERSE Phase 3 study in compensated cirrhosis due to NASH now expected in Q3 Company to host conference call today at 8:30 a.m. ET NEW YORK, March 02, 2022 (GLO

NEW YORK, Feb. 23, 2022 (GLOBE NEWSWIRE) -- Intercept Pharmaceuticals, Inc. (NASDAQ:ICPT), a biopharmaceutical company focused on the development and commercialization of novel therapeutics to treat progressive non-viral liver diseases, will announce its fourth quarter and full year 2021 financial results prior to market open on Wednesday, March 2, 2022. The announcement will be followed by a conference call and audio webcast hosted by Intercept management at 8:30 a.m. ET to discuss the results. The conference call will be available on the investor page of our website at http://ir.interceptpharma.com or by calling (855) 232-3919 (toll-free) passcode 3258502. Archived webcasts will be avai

Worldwide Ocaliva® net sales of $92.8 million, representing 17% growth over the prior year quarter Company increases 2021 guidance of Ocaliva net sales to $355 million to $370 million and narrows Non-GAAP adjusted operating expense guidance to $380 to $395 million NASH data generation remains on track New PBC POISE long-term data accepted in a late-breaking presentation at The Liver Meeting® next month Completed successful debt exchange and share buy back Company to host conference call today at 8:30 a.m. ET NEW YORK, Nov. 03, 2021 (GLOBE NEWSWIRE) -- Intercept Pharmaceuticals, Inc. (NASDAQ:ICPT), a biopharmaceutical company focused on the development and commercialization of novel

NEW YORK, Oct. 27, 2021 (GLOBE NEWSWIRE) -- Intercept Pharmaceuticals, Inc. (NASDAQ:ICPT), a biopharmaceutical company focused on the development and commercialization of novel therapeutics to treat progressive non-viral liver diseases, will announce its third quarter 2021 financial results prior to market open on Wednesday, November 3, 2021. The announcement will be followed by a conference call and audio webcast hosted by Intercept management at 8:30 a.m. ET to discuss the results. The conference call will be available on the investor page of our website at http://ir.interceptpharma.com or by calling (855) 232-3919 (toll-free domestic) or (315) 625-6894 (international) passcode 6266006.

NEW YORK, July 19, 2021 (GLOBE NEWSWIRE) -- Intercept Pharmaceuticals, Inc. (NASDAQ:ICPT), a biopharmaceutical company focused on the development and commercialization of novel therapeutics to treat progressive non-viral liver diseases, will announce its second quarter 2021 financial results prior to market open on Thursday, July 29, 2021. The announcement will be followed by a conference call and audio webcast hosted by Intercept management at 8:30 a.m. ET to discuss the results. The conference call will be available on the investor page of our website at http://ir.interceptpharma.com or by calling (855) 232-3919 (toll-free domestic) or (315) 625-6894 (international) passcode 2919379. Ar

Worldwide Ocaliva® net sales of $81.7M, representing 12% growth over the prior year quarter Company narrows 2021 financial guidance; now expects worldwide Ocaliva net sales guidance of $325 million to $340 million and reiterates Non-GAAP adjusted operating expense guidance of $380 to $410 million Process between Intercept and FDA remains ongoing regarding updates to the Ocaliva U.S. Prescribing Information Intercept continues to work toward potential resubmission of OCA in NASH fibrosis in the U.S. Company to host conference call today at 8:30 a.m. ET NEW YORK, May 06, 2021 (GLOBE NEWSWIRE) -- Intercept Pharmaceuticals, Inc. (NASDAQ:ICPT), a biopharmaceutical company focused on the d

Worldwide Ocaliva® net sales of $83.3 million and $312.7 million for the fourth quarter and full year 2020, representing 18% and 25% growth over the prior year Intercept provides initial 2021 Worldwide Ocaliva Net Sales Guidance of $325 million to $355 million and Non-GAAP Adjusted Operating Expense Guidance of $380 to $410 million FDA interactions remain ongoing regarding newly identified safety signal (NISS) for liver disorder in a subset of PBC patients with cirrhosis; Update to Ocaliva label expected   Anticipated readout of REVERSE Phase 3 study in compensated cirrhosis due to NASH by end of 2021        Conference call scheduled for 8:30 a.m. ET today NEW YORK, Feb. 25, 2021 (GLO