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Ocaliva® (obeticholic acid or OCA) net sales of $83.7 million, representing 17% growth over the prior year quarter Company 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 $...
2023-08-01 11:17:37 ET Intercept Pharma ( NASDAQ: ICPT ) is scheduled to announce Q2 earnings results on Wednesday, August 2nd, before market open. The consensus EPS Estimate is -$0.46 (+32.4% Y/Y) and the consensus Revenue Estimate is $79.57M (+10.9% Y/Y). Over the la...
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 res...
2023-07-13 17:30:00 ET Summary Madrigal Pharmaceuticals, Inc. dual surrogate Primary endpoint being met in phase 3 MAESTRO-NASH study allowed for the rolling NDA submission of resmetirom for the treatment of patients with NASH. Potential for rolling NDA submission of resmetirom to...
2023-07-13 08:04:34 ET Intercept Pharmaceuticals ( NASDAQ: ICPT ) gained ~10% pre-market Thursday after H.C. Wainwright upgraded it to Buy from Sell, citing a novel drug combination the company is developing for an autoimmune disease called primary biliary cholangitis (PBC). ...
2023-06-29 10:48:14 ET Viking Therapeutics ( NASDAQ: VKTX ) traded higher for the second straight session on Thursday after analysts defended the biotech following a selloff triggered by strong data from Eli Lilly’s ( LLY ) experimental drug retatrutide for non-alcoholic ...
2023-06-29 08:29:48 ET Eco Wave Power ( WAVE ) +56% . RenovoRx ( RNXT ) +24% . Kintara Therapeutics ( KTRA ) +22% . Intelligent Living Application ( ILAG ) +15% . Joby Aviation ( JOBY ) +14% rallies 10% to new 52-week h...
2023-06-23 12:03:39 ET Summary The FDA confirmed the news everybody had been expecting yesterday - Intercept's obeticholic acid ("OCA") was rejected for approval in NASH. Safety data evaluated by the agency failed to establish a positive risk/benefit profile and the drug was rejec...
2023-06-23 07:33:10 ET A day after the FDA rejected its lead asset, obeticholic acid (OCA) for nonalcoholic steatohepatitis (NASH), Intercept Pharmaceuticals ( NASDAQ: ICPT ) announced Friday that the company will halt all NASH-related investments and cut approximately a third of it...
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 2024 ...
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MORRISTOWN, 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 therapeutics to treat rare and serious liver diseases, today announced five abs...
sNDA intended to satisfy post-marketing requirements to confirm a clinical benefit in patients with PBC Precedent-setting submission includes data from post-marketing studies COBALT and Study 401 as well as real-world evidence from a claims database and patient registries FDA has assign...
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% ...