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Introduction For two decades, the scientific advance of investigative drug candidates for PBC into clinical development seemed like an illusion. FDA approval of obeticholic acid (i.e. ocaliva) in 2016 as a breakthrough therapeutics developed by Intercept ( ICPT ) for patients with mild PBC...
Intercept Pharmaceuticals, Inc. (NASDAQ:ICPT) Q2 2019 Earnings Conference Call August 7, 2019 8:30 AM ET Company Participants Justine O'Malley - Vice President, Corporate Affairs Mark Pruzanski - Chief Executive Officer Jerry Durso - Chief Operating Officer Sandip Kapadia - C...
Intercept Pharma ( ICPT ) Q2 results : Revenues: $66.3M (+52.1%); Ocaliva net sales: $65.9M (+52.5%); Licensing revenue: $0.4M (unch). More news on: Intercept Pharmaceuticals, Inc., Healthcare stocks news, Earnings news and commentary, Stocks on the move, Read more ...
Intercept Pharma (NASDAQ: ICPT ): Q2 GAAP EPS of -$2.28 beats by $0.33 . More news on: Intercept Pharmaceuticals, Inc., Earnings news and commentary, Healthcare stocks news, Read more ...
Company delivers strongest quarter to date with worldwide Ocaliva ® net sales of $65.9 million in the second quarter of 2019, representing 53% growth versus the prior year quarter U.S. NDA filing for NASH on track for third quarter of 2019; EU MAA filing for NASH projec...
AMAG , ANIP , ATHM , ATKR , AVA , BCOR , BV , CNP , CORE , CPRI , CSTE , CVS , CYBR , DNR , DOC , ETM , EVOP , FUN , GOLF , GTN , HL , HZNP , ICPT , INGN , INXN , IONS , JELD , KELYA , LAMR , LL , LXP , MFA , MIDD , NRG , NVMI , NXST , NYT , ODP , OMI ...
NEW YORK, July 31, 2019 (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 2019 financial result...
Introduction Intercept Pharmaceutical's ( ICPT ) Ocaliva was FDA-approved in 2016, under the accelerated approval program, for primary biliary cirrhosis [PBC], a rare disease that lacks sufficient options. Ocaliva is the second drug approved for PBC. Approved in 1997, " UDCA is effecti...
Introduction: Theory Versus Reality Source Anyone who has run a clinical trial, treated a patient, started a new medical practice, etc., knows that many good ideas are just not as effective in reality as they are on paper- the difference between those ideas and well-executed plans alwa...
With several licenses acquired from well-known pharmaceutical companies, Mirum Pharmaceuticals ( MIRM ) is a name to be followed carefully after the IPO. The most appealing is its pipeline. The company owns two product candidates at Phase 3 of development and several candidates at Phase 2 of d...
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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% ...