reports
Intercept Announces FDA Acceptance of Supplemental New Drug Applicatio...
Intercept Announces FDA Acceptance of Supplemental New Drug Application for Ocaliva® (obeticholic acid) for the Treatment of PBC sNDA 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 evidence from a claims database and patient registriesFDA has assigned a PDUFA target action date of October 15, 2024 MORRISTOWN, N.J., Feb. 29, 2024 (GLOBE NEWSWIRE) -- Intercept Pharmaceuticals, Inc., a biopharmaceutical company and wholly owned...
Intercept Announces New Phase 2 Data Showing Significant Impact of OCA...
Intercept 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® 2023 Data 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 5-10 mg + bezafibrate 400 mg cohorts in both studies showed a >60% reduction from baseline in serum ALP (primary endpoint) Treatment-emergent adverse events were generally balan...
Intercept Announces New Findings from Long-term Extension of Landmark ...
Intercept Announces New Findings from Long-term Extension of Landmark POISE Trial in PBC Showing Importance of Biomarkers Beyond ALP at AASLD The Liver Meeting® 2023 New analysis demonstrates the impact of OCA on achievement of GGT
Alfasigma completes acquisition of Intercept Pharmaceuticals, Inc.
Alfasigma completes acquisition of Intercept Pharmaceuticals, Inc. BOLOGNA, 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 Alfasigma through its wholly owned subsidiary Interstellar Acquisition Inc. Following the completion of Alfasigma’s successful tender offer to purchase all outstanding shares of common stock of Intercept for USD 19.00 per share, net to the seller thereof in cash, without interest, less any applicable withh...
Alfasigma to Acquire Intercept Pharmaceuticals for $19.00 per Share in...
Alfasigma 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 Diseases Proposed 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 September 25, 2023Alfasigma adds Ocaliva®, the only FDA approved second-line treatment for PBC, a progressive autoimmune disease affecting the liver, which generated revenue of $152 million in 1H 2023Strengt...
Intercept Pharmaceuticals to Conduct Fireside Chats and One-on-One Mee...
Intercept Pharmaceuticals to Conduct Fireside Chats and One-on-One Meetings at Upcoming Investor Conferences MORRISTOWN, 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 serious liver diseases, today announced that Jerry Durso, President and Chief Executive Officer of Intercept, and Andrew Saik, Chief Financial Officer of Intercept, will participate in fireside chats and investor meetings at the following upcoming investor conferences...
Intercept Pharmaceuticals Reports Second Quarter 2023 Financial Result...
Intercept Pharmaceuticals Reports Second Quarter 2023 Financial Results and Provides Business Updates Ocaliva® (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 non-GAAP adjusted operating expense guidance of $350 million to $370 millionRestructuring plan is on track to reduce operating expenses by approximately $140 millionCompany expects to achieve meaningful profitability in 2024OCA-bezafibrate combination making considerable progres...
Intercept to Announce Second Quarter 2023 Financial Results on August ...
Intercept to Announce Second Quarter 2023 Financial Results on August 2, 2023 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 inves...
Intercept Announces Restructuring to Strengthen Focus on Rare and Seri...
Intercept Announces Restructuring to Strengthen Focus on Rare and Serious Liver Diseases and Significantly Reduce Operating Expenses Measures 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 Company anticipates achieving profitability in 2024R&D investment prioritized on fixed-dose combination of OCA and bezafibrate with potential to establish best-in-class clinical benefits in the treatment of PBCCompany lowers 2023 non-GAAP adjusted...
Intercept Presents New Data Showing Significant Impact of OCA-bezafibr...
Intercept Presents New Data Showing Significant Impact of OCA-bezafibrate Combination on Normalization of Multiple Biomarkers of PBC-Induced Liver Damage Planned 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 12 weeks ALP normalized in 75% of patients in the OCA 5-10 mg + bezafibrate 400 mg arm at 12 weeks Combination well-tolerated with lowest rates of pruritus observed in OCA 5-10 mg + bezafibrate 400 mg treatment arm Resul...
Intercept Receives Complete Response Letter from FDA for Obeticholic A...
Intercept Receives Complete Response Letter from FDA for Obeticholic Acid as a Treatment for Pre-Cirrhotic Fibrosis due to NASH 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 comme...
Intercept Announces New Data Showing Potential of Fixed-Dose Combinati...
Intercept 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 2023 Interim 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, ALT, and GGT at 12 weeks OCA 5-10 mg + bezafibrate 400 mg also showed rapid biochemical response of mean ALP to within normal range at 4 weeks Combination was well tolerated with l...
Intercept Pharmaceuticals to Conduct One-on-One Meetings with Investor...
Intercept Pharmaceuticals to Conduct One-on-One Meetings with Investors at the Jefferies Healthcare Conference June 7-8, 2023 MORRISTOWN, 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 non-viral liver diseases, today announced that it will be participating in investor meetings at the Jefferies Healthcare Conference at the Marriott Marquis in New York City on June 7-8, 2023. Meeting Details For investors attending the conference w...
Intercept Announces Outcome of FDA Advisory Committee Meeting for Obet...
Intercept Announces Outcome of FDA Advisory Committee Meeting for Obeticholic Acid as a Treatment for Pre-Cirrhotic Fibrosis due to NASH 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 Jun...
Intercept Pharmaceuticals Stock Trading Halted Today; FDA Advisory Com...
Intercept Pharmaceuticals Stock Trading Halted Today; FDA Advisory Committee to Review Obeticholic Acid as a Treatment for Pre-Cirrhotic Fibrosis due to NASH MORRISTOWN, 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 non-viral liver diseases, today announced that NASDAQ has halted trading of the company’s common stock. The U.S. Food and Drug Administration’s (FDA) Gastrointestinal Drugs Advisory Committee (GIDAC) is meeting toda...
Intercept Pharmaceuticals Receives FDA Orphan Drug Designation for the...
Intercept Pharmaceuticals Receives FDA Orphan Drug Designation for the Fixed-Dose Combination of OCA and Bezafibrate for the Treatment of Primary Biliary Cholangitis (PBC) Company 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 bezafibrate on serum biomarkers in PBC to be presented at EASL Congress 2023 MORRISTOWN, N.J., May 16, 2023 (GLOBE NEWSWIRE) -- Intercept Pharmaceuticals, Inc. (Nasdaq: ICPT), a biopharmaceutical compan...
Intercept Pharmaceuticals Reports First Quarter 2023 Financial Results...
Intercept Pharmaceuticals Reports First Quarter 2023 Financial Results and Provides Update on Commercial Launch Strategy for NASH Ocaliva® 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 treatment for pre-cirrhotic fibrosis due to NASH; PDUFA Target Action Date set for June 22, 2023 Company updates progress of OCA-bezafibrate fixed-dose combination development program in PBC, including acceptance of new Phase 2 data at EASL Congress ...
Intercept Announces New Data to be Presented at The European Associati...
Intercept 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 Program Seven 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 2 study of investigational combination of obeticholic acid (OCA) and bezafibrate in PBC Company expects to complete planned interim analyses from two ongoing Phase 2 s...
Intercept to Announce First Quarter 2023 Financial Results and Provide...
Intercept to Announce First Quarter 2023 Financial Results and Provide Update on Commercial Launch Strategy for NASH on April 27, 2023 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...
Intercept Announces FDA Advisory Committee Meeting Date for Obeticholi...
Intercept Announces FDA Advisory Committee Meeting Date for Obeticholic Acid as a Treatment for Pre-Cirrhotic Liver Fibrosis due to NASH Advisory 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 company focused on the development and commercialization of novel therapeutics to treat progressive non-viral liver diseases, today announced that the Gastrointestinal Drugs Advisory Committee (GIDAC) of the U.S. Food and Drug Administrati...
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